Timing the First Pediatric Tracheostomy Tube Change: A Randomized Controlled Trial

Abstract

Objective

The first pediatric tracheostomy tube change often occurs within 7 days after placement; however, the optimal timing is not known. The primary objective was to determine the rate of adverse events of an early tube change. Secondary objectives compared rates of significant peristomal wounds, sedation requirements, and expedited intensive care discharges.

Study Design

Prospective randomized controlled trial.

Setting

Tertiary children’s hospital between October 2018 and April 2020.

Methods

A randomized controlled trial enrolled children under 24 months to early (day 4) or late (day 7) first tracheostomy tube changes.

Results

Sixteen children were enrolled with 10 randomized to an early change. Median age was 5.9 months (interquartile range, 5.4-8.3), and 86.7% required tracheostomy for respiratory failure. All tracheostomy tube changes were performed without adverse events. There were no accidental decannulations. Significant wounds developed in 10% of children with early tracheostomy tube changes and 83.3% of children with late tracheostomy tube changes (odds ratio [OR], 45.0; 95% CI, 2.3-885.6; P = .01). This significant reduction in wound complications justified concluding trial enrollment. Hours of dexmedetomidine sedation (P = .11) and boluses of midazolam during the first 7 days (P = .08) were no different between groups. After the first change, 90% of the early group were discharged from intensive care within 5 weeks compared to 33.3% of patients in the late group (OR, 18.0; 95% CI, 1.2-260.9; P = .03).

Conclusion

The first tracheostomy tube change in children can occur without adverse events on day 4, resulting in fewer significant peristomal wounds and earlier intensive care discharge.

Keywords

pediatric peristomal wounds tracheostomy tracheostomy tube change

The first tracheostomy tube change occurs after the tracheotomy tract has adequately matured to safely allow subsequent tube changes.^1,2 Complication rates after pediatric tracheostomy range from 20% to 51%,^3-8 with many developing in the first 7 days.^4,6,7 During this early postoperative period, concern for accidental decannulation⁹ is balanced with increased peristomal or cervical wound complications.^6,10-12 Furthermore, attempting to replace a tube through an immature tract raises concern of creating a false passage into the mediastinum.^13,14 Consequently, the first tracheostomy tube change is a critically important milestone in the care of these children.

The optimal time to perform the first tracheostomy tube change is unknown. Factors influencing this decision include specific anatomic or medical considerations for the individual patient.¹⁵ Historically, most surgeons select between 5 and 7 days after placement.^16,17 Several retrospective reviews have suggested that changes as early as postoperative day 2 or 3 is safe in pediatric patients.^2,18,19 A consensus panel convened by the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) felt that waiting until days 5 to 7 was necessary to establish a mature tract.²⁰ Ultimately, the timing of the first tracheostomy tube change should occur at the discretion and tradition of the surgeon.^14,18,21

This study compared outcomes of an early first tracheostomy change on postoperative day 4 with a later first change on day 7 in children. The primary outcome was the development of any adverse event in the interval between tracheostomy placement and the first tube change. Secondary outcomes included length of intensive care admission, amount of sedation, and presence of significant peristomal or cervical skin wounds.

Methods

Trial Design

This single-center study was a prospective, randomized controlled trial conducted between 2018 and 2020. The Children’s Hospital of Philadelphia (CHOP) Institutional Review Board (IRB) approved this project (IRB 17-014348) beginning October 26, 2018, and a registration at ClinicalTrials.gov was created (NCT04105387). The Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement²² provided guidance for the reporting of this trial. Close monitoring of outcomes and safety commenced continuously and at a scheduled 12-month review by the IRB.

Participants

A CONSORT flowchart of participants is shown in Figure 1 . Children 24 months and younger at the time of tracheostomy placement were eligible. Patients were recruited from the neonatal intensive care unit (NICU), pediatric intensive care unit (PICU), and cardiac intensive care unit (CICU) at CHOP between October 2018 and March 2020. This tertiary children’s hospital is an international referral center with over 100 NICU beds, 68 PICU beds, and 32 CICU beds. Critical care services approved offering enrollment to caregivers within the first 72 hours after tracheostomy placement.

Exclusion criteria included any anatomical or physiological anomalies identified preoperatively or intraoperatively that could increase the difficulty of performing an early tracheostomy tube change. This included previous neck surgery, concomitant surgery near the tracheostomy site, inability to be confidently intubated by the critical care service, or anatomy that made oral intubation difficult for an experienced pediatric otolaryngologist. A short or thick neck, significant cervical adiposity, extreme body mass index (BMI), kyphosis, or mass overlying the trachea were anatomical reasons for exclusion. Any child receiving immunotherapy, chemotherapy, radiation, or with a known diagnosis contributing to poor wound healing such as malnutrition or epidermolysis bullosa was excluded for physiologic reasons. In-person written consent from caregivers needed to be obtained by the study team before enrollment. Initially, if tracheostomy placement occurred on a Tuesday or Wednesday, an eligible child was not offered participation in order to avoid an early change on a Saturday or Sunday. However, several adjustments to enrollment criteria occurred at the 12-month IRB review to allow for increased eligibility. Specifically, the trial offered participation to tracheostomies performed Monday through Friday, obtained telephone consent with written signature before postoperative day 4, and defined difficult intubation as at least grade 3 subglottic stenosis or inability for mask ventilation.

After caregiver permission for enrollment, subjects were assigned to treatment groups by simple (1:1) randomization. Assignment to control or intervention group was written and contained within individual sealed envelopes that were drawn by hand in a random order. The lead investigator (S.R.C.) removed the envelope and notified the family and clinical team of the group, and therefore no blinding to study arm occurred.

Interventions

The intervention was a first tracheostomy tube change on postoperative day 4 classified as early. A control group had the first tracheostomy tube change on postoperative day 7, which is the standard at this institution. All tracheostomy procedures included the placement of right and left stay sutures that were removed at the conclusion of the first tube change. Although a small amount of cervical adipose tissue was removed at the time of surgery, no stoma maturation sutures were placed. Tracheostomy tubes were secured with soft ties, and no sutures were used to secure the tube. During the first week after tracheostomy placement, the stoma and cervical skin were meticulously assessed daily by a team of 5 advanced practice registered nurses from the pediatric otolaryngology service. Soiled ties could be replaced prior to the first tracheostomy tube change by the advanced practice nurses. After 7 days, these assessments occurred at least twice weekly for the next 2 weeks unless wound concerns warranted closer monitoring. Logistically, blinding to the group could not occur, but this source of potential bias was mitigated by using the same schedule of wound assessments and same team of experienced registered nurses regardless of trial arm. As required by the IRB and study team, all early changes were performed by a pediatric otolaryngology nurse practitioner with a pediatric otolaryngology fellow or attending present. All control group changes occurred by a pediatric otolaryngology nurse practitioner with an otolaryngology resident. A standard protocol to the first tracheostomy tube change was used. These procedures include a tracheoscopy, meticulous cleaning of the incision site, and the involvement of respiratory therapy, critical care, and nursing staff. Silicone dressings were used universally and silver-impregnated dressings were used for advanced peristomal wounds, if necessary.

Outcomes

There were no changes to the primary or secondary outcome measures during the course of this study. Demographics including age, sex, gestational age, birth weight, and weight were recorded along with indication for tracheostomy. Complications included, but were not limited to, the development of skin wounds, accidental decannulation, placement of the tracheostomy tube into a false passage, tube occlusion, significant ventilation issues, cardiopulmonary arrest, or death. Significant cervical or peristomal wound complications were characterized by measurable depth, multiple wounds, length greater than 5 mm, or grossly infected wounds. Medications commonly used for sedation and chemical paralysis were recorded during the first 7 days after tracheostomy placement. Length of intensive care unit (ICU) admission, time until tracheostomy placement, and ICU discharges at 2 and 5 weeks were identified. Children were followed until hospital discharge or discharge from the ICU.

Statistical Methods

An a priori power analysis was performed to estimate an appropriately sized study population. The analysis was designed to detect a difference in tracheostomy complication rates between the 2 groups. Previously published complication rates can vary between 20% and 50%,^5,6 and therefore, a difference in complications of 30% was proposed as clinically significant. To achieve 80% power using a 2-sided test with an α of 0.05, the control and treatment arms would need approximately 38 subjects. In addition, the study group monitored outcomes during the trial and if a significant difference between treatment arms emerged before reaching the anticipated sample size enrollment would conclude.

Analysis was performed using SPSS Statistics for Windows (version 25.0; SPSS, Inc). Normality of data was determined using a Shapiro-Wilk test. For normally distributed continuous variables, means and 95% confidence intervals were shown along with parametric testing of significance using 2-tailed Student t tests. If continuous variables were not normally distributed, medians and interquartile ranges (IQRs) were shown, and nonparametric comparison by 2-tailed Mann-Whitney U testing was used. Categorical values were represented by the absolute number along with percentage. Testing for statistical significance for categorical values was performed by Fisher exact tests including odds ratios (ORs) with 95% confidence intervals. An intention-to-treat analysis included all randomized patients, and significance levels were set at P < .05.

Results

Table 1 compares baseline demographics between the day 7 and day 4 change groups. A total of 16 children were enrolled with 10 (62.5%) randomized to a day 4 change. The median age at tracheostomy was 5.9 months (IQR, 5.4-8.3), 56.3% were male, and median gestational age was 32.1 weeks (IQR, 25.1-37.5). Indication for tracheostomy was respiratory failure in 87.5% of children. The groups were statistically similar with respect to baseline characteristics. There was no attrition or exclusion after randomization, and all children enrolled were included for analysis. Eligible participants were recruited for a total of 18 months between October 2018 and April 2020.

Table 1.

Patient Characteristics Separated by Treatment Arm.^a

Patient Characteristic	All patients	Day 7 change	Day 4 change	P value
Total No. (%)	16 (100)	6 (37.5)	10 (62.5)
Age at tracheostomy, mo	5.9 (5.4-8.3)	6.0 (5.5-8.0)	5.8 (5.3-8.2)	.91
Males, No. (%)	9 (56.3)	3 (50)	6 (60)	1.0
Weight, kg	6.3 (5.3-8.1)	5.7 (5.1-7.7)	7.0 (5.5-7.9)	.59
Gestational age, wk	32.1 (25.1-37.5)	28.5 (25.4-37.4)	33.0 (24.6-36.5)	1.0
Birth weight, kg	1.7 (0.7-2.5)	0.9 (0.6-2.7)	2.2 (0.8-2.5)	.56
Race, No. (%)
White	5 (31.3)	3 (50)	2 (20)	.34
Black or African American	4 (25)	2 (33.3)	2 (20)
Other^b	7 (43.7)	1 (16.7)	6 (60)
Indication for tracheostomy, No. (%)
Respiratory failure^c	14 (87.5)	4 (66.7)	10 (100)	.13
Airway obstruction^d	2 (12.5)	2 (33.3)	0 (0)

Continuous data represented as median with interquartile range.

Includes Asian, other, or refused.

Includes bronchopulmonary dysplasia and central apnea.

Includes tracheomalacia and obstructive sleep apnea.

No major complications or significant adverse events occurred among any child in this study. There were no unintended harms or consequences in either group. All early and late tracheostomy tube changes were successfully performed without difficulty. Qualitative concerns over the formalization of the tracheostomy stoma on day 4 could not be identified ( Figure 2 ). The development of peristomal skin wounds ( Figure 3 ) remained the only postoperative complication recorded in this trial. As shown in Table 2 , 80% of significant peristomal wounds were identified on postoperative day 4 or later. In addition, only 1 child in the early change group had a significant wound, and this was recorded on the day of the first tracheostomy tube change. All wounds were managed conservatively using regular dressing changes, with or without packing of the wound depth using silver-impregnated dressings. No skin cellulitis or abscess requiring antibiotics developed.

Table 2.

Timing and Description of Significant Peristomal Skin Wounds.

Patient No.	Group	Age, mo	Sex	Day noted	Description
1	Day 4	9.1	Male	4	Shallow stoma breakdown superiorly, 10 × 4 mm with 2-mm depth
2	Day 7	8.5	Female	6	Multiple small abrasions (<3 mm) under the right tracheostomy tube flange and ties
3	Day 7	2.8	Male	4	Granulation of inferior stoma between 4 and 8 o’clock with 3-mm depth
4	Day 7	6.2	Female	4	Widening between 9 and 3 o’clock and the superior stoma with minimal wound depth
5	Day 7	9.5	Male	4	Open stoma incision superiorly between 10 and 11 o’clock, extending laterally by 7 mm
6	Day 7	5.4	Female	1	Stoma breakdown superiorly, 2.0 × 1.6 cm with 8-mm depth

In Table 3 , the timing of clinical events is described. Duration of ICU admission, time until tracheostomy placement, and proportion of admission prior to tracheostomy were no different between groups. After the first tracheostomy tube change, the day 7 group was discharged from the ICU at a median of 35.0 days (IQR, 15.0-55.0) compared to 22.0 days (IQR, 10.3-28.3) for the day 4 group (P = .43). All children were followed until discharge from the intensive care unit except 1 child (day 7 group) who remains in the ICU at the time of this writing for over 20 months secondary to complex medical care. Table 4 shows the odds of wound complications and timeframe for intensive care discharges. Children in the day 7 group were more likely to have significant peristomal wound breakdown within the first week after tracheostomy placement (OR, 45.0; 95% CI, 2.3-885.6; P = .01). Although children in the day 4 group were no more likely to have an ICU discharge within 2 weeks (OR, 3.3; 95% CI, 0.3-40.3; P = .59), an ICU discharge within 5 weeks after first change was significantly higher (OR, 18.0; 95% CI, 1.2-260.9; P = .03). Given the significant reduction in peristomal wounds identified in the early change group, trial enrollment concluded earlier than anticipated due to the impressive improvement in this outcome.

Table 3.

Timing of Clinical Events Separated by Treatment Arm.^a

Characteristic	All Patients	Day 7 change	Day 4 change	P value
Length of ICU admission, mo	4.9 (3.4-7.1)	5.9 (4.1-6.1)	4.5 (3.1-7.4)	.90
Time until tracheostomy, mo	3.5 (2.4-5.1)	3.9 (2.4-4.9)	3.5 (2.6-5.2)	1.0
ICU admit prior to tracheostomy, %^b	75.0 (63.4-86.0)	76.9 (66.8-88.0)	67.5 (61.7-76.3)	.37
ICU discharge after first change, d	22.0 (10.5-34.0)	35.0 (15.0-55.0)	22.0 (10.3-28.3)	.43
ICU discharge after tracheostomy, d	26.0 (14.5-39.5)	42.0 (22.0-62.0)	26.0 (14.3-32.3)	.33

All values are presented as median or percentage with interquartile range.

This represents the percentage of intensive care unit (ICU) admission prior to placement of tracheostomy.

Table 4.

Comparison of Clinical Outcomes Between Treatment Groups.

Characteristic	Day 7 change, No. (%)	Day 4 change, No. (%)	OR (95% CI)	P value
Silver-based stoma dressing	4 (66.7)	6 (60)	0.8 (0.1-6.2)	1.0
Peristomal wound breakdown	5 (83.3)	1 (10)	45.0 (2.3-885.6)	.01
ICU discharge within 2 weeks	1 (16.7)	4 (40)	3.3 (0.3-40.3)	.59
ICU discharge within 5 weeks	2 (33.3)	9 (90)	18.0 (1.2-260.9)	.03

Abbreviations: ICU, intensive care unit; OR, odds ratio.

As represented in Table 5 , medication requirements for all children were tracked during the first 7 days after tracheostomy placement. No statistically significant difference was identified between study arms. Hours of infusion for vecuronium (P = .88), dexmedetomidine (P = .11), and midazolam (P = .26) were no different between groups. There was no difference between the early change group and the control group with respect to boluses of midazolam (P = .08).

Table 5.

Medication Requirements During the First Week After Tracheostomy Placement.

Characteristic	Day 7 change, mean (95% CI)	Day 4 change, mean (95% CI)	Percent reduction	P value
Vecuronium infusion, h	65.5 (0-140.5)	60.6 (19.1-102.0)	7.0	.88
Dexmedetomidine infusion, h	157.9 (127.1-188.6)	111.6 (67.4-155.7)	29.3	.11
Midazolam infusion, h	164.1 (138.8-189.4)	136.9 (98.6-175.2)	16.6	.26
Midazolam boluses, No.	23 (11.5-34.5)	12.2 (4.3-20.1)	47.0	.08

Discussion

Clinicians should judiciously approach decisions pertaining to the care of children in the days following tracheostomy placement. Tracheostomy in patients younger than 2 years has the largest relative 30-day morbidity in pediatric otolaryngology and represents a meaningful target for quality improvement interventions.²³ A few retrospective studies have reported the safety of an earlier first tracheostomy tube change in children.^2,14,18,19 Benefits of expeditiously confirming a patent stoma include reduced risk of skin breakdown and earlier transfer to general care. This prospective randomized controlled trial provides evidence to support these findings.

The first tracheostomy tube change provides crucial reassurance for the safety of future exchanges. Caregivers must practice caution until a stable, epithelialized tract from the tracheal wall to the subcutaneous tissue has formed.^1,14 Potential complications of premature tracheostomy tube changes include the creation of a false passage, pneumothorax, and the inability to control the airway.¹⁸ A survey of otolaryngology training programs highlighted significant variability in the first tube change procedure, with 42% of chief residents aware of an event leading to loss of the airway and 15% aware of a death.¹³ Confidence that clinicians can perform this first change safely remains paramount. The results from this small trial suggest no adverse events of a first tube change at 4 days in children and identified no qualitative difference in maturation compared to a stoma after 7 days.

The most impressive outcome in this study was the reduction in significant peristomal wound complications in the early change group. Children in the day 7 change group had a significantly higher risk of developing consequential skin breakdown in the week following tracheostomy. Notably, all but 1 were identified on day 4 or later, which suggests a possible window for mitigating these complications. Anxiety over accidental decannulation leads to tightly fitting neck ties and incomplete or inconsistent skin examinations until the first tube change.^12,18 Studies suggest that as many as 30% of children will develop posttracheostomy wound complications¹⁰ and that nearly 65% of all complications after tracheostomy are wound related.⁷ Poor nutritional status, immobility, and inability to express discomfort combine with moisture and device friction to place critically ill children at a higher risk for skin breakdown.¹¹ Implementation of a standardized protocol with daily, multidisciplinary neck inspections along with shifting the first change from day 7 to day 3 or 4 resulted in a significant decrease in the rate of skin breakdown in a prior report.¹⁴ Although skin complications are multifactorial in etiology, earlier and more complete stoma evaluations could identify many of these preventable events.

Children in the earlier change group were more likely to be out of intensive care within 5 weeks. In 2012, approximately half of the 4400 pediatric tracheostomies performed in the United States occurred in children aged less than 2 years.²⁴ After tracheostomy placement, children require a tremendous amount of health care resources,²⁵ and clinicians should strive for quality improvement initiatives to optimize care.²⁶ A prior retrospective series found that 46% of children could be transferred out of the ICU on the same day as a postoperative day 3 change. However, nearly 33% of all patients in that study left the ICU on the same day as their first change and had an average ICU admission of less than 1 month.¹⁹ The prospective results shown here point to a complex patient population with long ICU and hospital admissions. Therefore, as any clinician caring for these children will recognize, there are often many influencing factors on when discharge could occur. An earlier first tube change should facilitate a transition to noncritical care when the tracheostomy is the final item pending.

No reduction in medications used for sedation and chemical paralysis was identified in this trial. While some children may only require analgesia after tracheostomy, others may warrant additional measures to reduce potential for self-decannulation.²¹ A recent survey found that most otolaryngologists do not routinely use chemical paralysis following tracheostomy, and among those that use sedation, most will stop this prior to the first tracheostomy tube change.²⁷ Efforts to avoid accidental decannulation are particularly high prior to the first tube exchange. Therefore, some children will remain largely immobile by restraint or chemical paralysis until this event occurs. There is some evidence to suggest that early mobilization of children in intensive care can improve outcomes.^28,29 At this institution, once the first change occurs, parents may hold their children out of the crib, nursing care can focus on more freedom of movement, and active tracheostomy caregiver education may begin. Performing these important activities can have an immeasurable impact on the patient-caregiver relationship that would otherwise not occur while the concern over an immature stoma continues.

Determining the optimal time for the first tracheostomy tube change depends on several factors. A multidisciplinary approach should consider various comorbidities such as cardiopulmonary disease, need for significant mechanical ventilation, poor healing potential, and sepsis.² Some children will have anatomical restrictions or healing concerns that justify waiting to ensure definitive stomal maturation prior to the tube change.¹⁹ Excluding children from this trial with any of those risks should guide clinicians under circumstances when the anticipated change is uncomplicated.

Limitations

One limitation of this study is the small sample size. The impressive reduction in significant peristomal wounds that emerged in the early change group justified concluding enrollment earlier than anticipated. Prior to this, caregiver hesitancy also contributed to the exclusion of several candidates for trial entry. Future work might also consider the reluctance to participate by the parents experiencing the well-known stress and anxiety in caring for a child with a tracheostomy.^30,31 Second, this trial selected only children under the age of 2 years. It is unclear what the generalizability of these results might be to older children. Third, this institution benefits from meticulous tracheostomy care and a multidisciplinary team effort in caring for children after surgery. Prior studies have supported improved outcomes from this approach and therefore may limit extrapolation to institutions where these initiatives are less robust.^12,14

Conclusion

The first tracheostomy tube change in children can occur without adverse events on day 4, resulting in fewer peristomal wounds and earlier intensive care discharge. Clinicians might consider the information presented in this trial when coordinating timing of first tracheostomy change for pediatric patients. Further research should continue to look for strategies that optimize care in the early period following tracheostomy placement in children.

Footnotes

This article is accepted for a virtual podium presentation at the AAO-HNSF 2020 Annual Meeting & OTO Experience; September 13-16, 2020; Boston, Massachusetts.

Author Contributions

Stephen R. Chorney, study design, data acquisition and interpretation, manuscript drafting and revision, final manuscript approval; Rosemary C. Patel, data acquisition and interpretation, manuscript revision, final manuscript approval; Allison E. Boyd, data acquisition and interpretation, manuscript revision, final manuscript approval; Joanne Stow, data acquisition and interpretation, manuscript revision, final manuscript approval; Mary M. Schmitt, data acquisition and interpretation, manuscript revision, final manuscript approval; Deborah Lipman, data acquisition and interpretation, manuscript revision, final manuscript approval; Julia F. Dailey, data acquisition and interpretation, manuscript revision, final manuscript approval; Carol Nhan, study design, manuscript revision, final manuscript approval; Terri Giordano, study design, data acquisition and interpretation, manuscript revision, final manuscript approval; Steven E. Sobol, study design, data acquisition and interpretation, manuscript drafting and revision, final manuscript approval.

Disclosures

Competing interests: None.

Sponsorships: None.

Funding source: None.

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