Abstract
Background
Patients with unstable cervical spine (C-spine) fractures are at a significant risk of respiratory failure. There is no consensus on the optimal timing of tracheostomy in the setting of recent operative cervical fixation (OCF). This study evaluated the impact of tracheostomy timing on surgical site infections (SSIs) in patients undergoing OCF and tracheostomy.
Methods
Trauma Quality Improvement Program (TQIP) was used to identify patients with isolated cervical spine injuries who underwent OCF and tracheostomy between 2017 and 2019. Early tracheostomy (<7 days from OCF) was compared with delayed tracheostomy (≥7 days from OCF). Logistic regressions identified variables associated with SSI, morbidity, and mortality. Pearson correlations evaluated time to tracheostomy and length of stay (LOS).
Results
Of 1438 patients included, 20 had SSI (1.4%). There was no difference in SSI between early vs delayed tracheostomy (1.6% vs 1.2%, P = .5077). Delayed tracheostomy was associated with increased ICU LOS (23.0 vs 17.0 days, P < .0001), ventilator days (19.0 vs 15.0, P < .0001), and hospital LOS (29.0 vs 22.0 days, P < .0001). Increased ICU LOS was associated with SSI (OR 1.017; CI 0.999-1.032; P = .0273). Increased time to tracheostomy was associated with increased morbidity (OR 1.003; CI 1.002-1.004; P < .0001) on multivariable analysis. Time from OCF to tracheostomy correlated with ICU LOS (r (1354) = .35, P < .0001), ventilator days (r (1312) = .25, P < .0001), and hospital LOS (r (1355) = .25, P < .0001).
Conclusion
In this TQIP study, delayed tracheostomy after OCF was associated with longer ICU LOS and increased morbidity without increased SSI. This supports the TQIP best practice guidelines recommending that tracheostomy should not be delayed for concern of increased SSI risk.
Key Takeaways
Early tracheostomy is not associated with an increased risk of surgical site infection in patients who have recently undergone operative cervical fixation. Delayed tracheostomy in this population is associated with increased ICU length of stay, hospital length of stay, and more ventilator days.
Introduction
Patients with cervical spinal cord injuries are at a significant risk of respiratory decompensation and failure. Many patients who suffer these injuries require mechanical ventilation and ultimately tracheostomy placement, with rates of tracheostomy placement ranging from 20.6% to 79.5% in recent literature.1–3 Most patients with cervical spinal cord injuries additionally require operative cervical fixation (OCF) soon after their initial presentation with the injury. 4 There has been some debate regarding the optimal timing of tracheostomy relative to OCF, due to theoretical concern of increased risk of surgical infection.
The American College of Surgeons Trauma Quality Programs – Spine Injury Guidelines were published in March 2022 and stated that tracheostomy can be performed early relative to cervical spinal fixation without an increased risk of surgical site infection. 4 To our knowledge, there has not been a national study reviewing rates of SSI in this population. Moreover, despite this recommendation from ACS, some institutions have yet to embrace these guidelines. We hypothesized delayed tracheostomy would increase length of stay without mitigating the risk of SSI, morbidity, or mortality.
Methods
Data Source and Patient Selection
The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP) collects data from over 875 trauma centers across the United States with the aim of improving patient outcomes through risk-adjusted benchmarking. Patients’ injuries are categorized using International Statistical Classification of Diseases and Health-Related Problems-10th edition (ICD-10) codes. As cases within the TQIP databases are de-identified and readily available, the Institutional Review Board at the University of Tennessee Health Science Center granted this study exemption from the approval process (IRB 23-09184-NHSR).
Patients with the appropriate ICD-10 codes corresponding to “Fusion of spine, cervical region” and “Tracheostomy” were selected from the 2017 to 2019 ACS TQIP database using a substring word search by ICD-10 description codes. Patients were excluded from the analysis if they did not undergo both OCF and tracheostomy, if they had Abbreviated Injury Scale (AIS) scores of >3 in any region other than the spine, or if they had incomplete data regarding completion and/or timing of OCF and/or tracheostomy. Complete details of patient selection are contained in Supplemental Figure 1.
Timing of Tracheostomy and Outcomes
The timing and duration of OCF and tracheostomy were recorded for every patient. Early tracheostomy was defined as <7 days from OCF, and late tracheostomy was defined as ≥7 days from OCF. Patient data (age, sex, presence of cirrhosis, congestive heart failure [CHF], chronic obstructive pulmonary disease [COPD], diabetes mellitus [DM], chronic renal failure [CRF], and history of smoking), clinical data (systolic blood pressure [SBP], heart rate [HR], respiratory rate [RR], Glasgow Coma Scale [GCS] on presentation, and Injury Severity Score [ISS]), and patient outcomes (SSI, ventilator-associated pneumonia [VAP], composite morbidity, mortality, ICU LOS [LOS], ventilator days, and hospital LOS) were compared between patients undergoing early vs late tracheostomy. Composite morbidity was a combination of the following outcomes: central-line associated blood stream infection (CLABSI), deep SSI, deep vein thrombosis (DVT), alcohol withdrawal syndrome, cardiac arrest with CPR, catheter-associated urinary tract infection (CAUTI), pulmonary embolism (PE), unplanned intubation, acute kidney injury (AKI), myocardial infarction (MI), organ space SSI, osteomyelitis, acute respiratory distress syndrome (ARDS), unplanned return to operating room, cerebrovascular accident (CVA), superficial SSI, pressure ulcer, unplanned admission to ICU, and VAP.
Statistical Analysis
All statistical analyses were performed using R Version 4.2.1 (The R Foundation, Vienna, Austria) and GraphPad Prism Version 9.4.0 (GraphPad Software, LLC., San Diego, CA). Continuous data were reported using medians and interquartile ranges (IQRs) and compared using Mann-Whitney U Tests. Categorical data were reported using relative frequencies and percentages and compared using Fisher’s exact tests or Chi-square tests where appropriate. Univariate analyses were used to compare patients who underwent early tracheostomy with those who underwent delayed tracheostomy. Factors associated with SSI, overall morbidity, and mortality were compared using simple logistic regression. Multiple logistic regression was used to assess factors associated with morbidity and mortality. The Hosmer-Lemeshow goodness-of-fit test was used to evaluate the fit of the multivariable models. Pearson correlations were performed to evaluate the relationship between days from OCF to tracheostomy and ICU LOS, ventilator days, and hospital LOS. All hypothesis testing was two-sided, and P-values less than .05 were used as the initial alpha. To account for multiple hypothesis testing during univariate analyses, Bonferroni-corrected alphas of < .002 were used to denote statistical significance.
Results
Patient and Injury Data
Univariate Analyses Comparing Patients Who Underwent Tracheostomy <7 Days From OCF With Those Who Underwent Tracheostomy ≥7 Days From OCF. Bonferroni Corrected P-Values of P < .002 Were Used to Denote Statistical Significance.
Abbreviations: OCF, operative cervical fixation; IQR, interquartile ratio; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; DM, diabetes mellitus; CRF, chronic renal failure; SBP, systolic blood pressure; HR, heart rate; BPM, beats per minute; BrPM, breaths per minute; GCS, Glasgow Coma Scale; SSI, surgical site infection; LOS, length of stay.
Treatment Data
Rates of open tracheostomy (versus percutaneous) were similar between the cohorts (55.0% vs 55.3%, P = .9577) (Table 1). The median time from OCF to tracheostomy in the early tracheostomy group was 100.2 hours [IQR 66.6-139.3] vs 264.9 hours in the late tracheostomy group [IQR 209.1-354.9].
Surgical Site Infections
Simple Logistic Regression for Surgical Site Infection Among Patients Undergoing OCF and Tracheostomy.
Abbreviations: OCF, operative cervical fixation; OR, odds ratio; CI, confidence interval; COPD, chronic obstructive pulmonary disease; SBP, systolic blood pressure; HR, heart rate; BPM, beats per minute; BrPM, breaths per minute; LOS, length of stay.
Patient Composite Morbidity
Simple and Multiple Logistic Regression for Morbidity Among Patients Undergoing OCF and Tracheostomy.
Abbreviations: OCF, operative cervical fixation; IQR, interquartile ratio; OR, odds ratio; CI, confidence interval; COPD, chronic obstructive pulmonary disease; SBP, systolic blood pressure; HR, heart rate; BPM, beats per minute; BrPM, breaths per minute; GCS, Glasgow Coma Scale; ICU, intensive care unit; LOS, length of stay.
Patient Mortality
Simple and Multiple Logistic Regression for Mortality Among Patients OCF and Tracheostomy.
Abbreviations: OCF, operative cervical fixation; IQR, interquartile ratio; OR, odds ratio; CI, confidence interval; COPD, chronic obstructive pulmonary disease; SBP, systolic blood pressure; HR, heart rate; BPM, beats per minute; BrPM, breaths per minute; GCS, Glasgow Coma Scale; ICU, intensive care unit; LOS, length of stay.
ICU Length of Stay, Ventilator Days, and Hospital Length of Stay
Patients in the early tracheostomy group had significantly decreased ICU LOS (17.0 days vs 23.0 days; P < .0001), number of ventilator days (15.0 vs 29.0 days; P < .0001), and hospital LOS (22.0 vs 29.0 days; P < .0001) (Table 1). Pearson correlation analysis revealed significant correlations between time from OCF to tracheostomy and ICU LOS (r (1354) = .35, P < .0001), ventilator days (r (1312) = .25, P < .0001), and hospital LOS (r (1355) = .25, P < .0001) (Supplemental Table 1).
Discussion
The data show that patients who underwent early vs delayed tracheostomy were similar in terms of age, race, and comorbidities. Our study found no association between early tracheostomy and SSI. Early tracheostomy was associated with significantly shorter ICU LOS, shorter hospital LOS, fewer ventilator days, and decreased composite morbidity.
Relationship of Tracheostomy Timing with SSI
In March of 2022, the American College of Surgeons (ACS) Trauma Quality Programs published best practice guidelines stating that tracheostomy can be performed early relative to cervical spinal fixation without an increased risk of surgical site infection. 4 However, this guideline was supported by data collected from only single institution cohort studies, the largest of which had an n = 98.5–11 Therefore, we believe this is the first national database study to evaluate the association of timing to tracheostomy and SSI in the OCF population. Notably, even with 1438 patients included in our study, only 20 patients (1.4%) with SSI were identified, demonstrating that infection of the cervical fixation site is an overall rare event in the presence of tracheostomy, regardless of timing. Despite the overall rarity of SSI in this population, hardware infection does confer a serious risk of both morbidity and mortality that makes it worthwhile to investigate. In our study, when patients were stratified based on timing of tracheostomy, there was no difference in rates of SSI (1.6% vs 1.2%; P = .5077).
Relationship of Tracheostomy Timing with Composite Morbidity
In our study, early tracheostomy was associated with lower composite morbidity (58.8% vs 69.7%, P < .0001). This variable was a composite of the following outcomes: CLABSI, SSI, DVT, alcohol withdrawal syndrome, cardiac arrest with CPR, CAUTI, PE, unplanned intubation, AKI, MI, osteomyelitis, ARDS, unplanned return to operating room, CVA, pressure ulcer, unplanned admission to ICU, and VAP. This outcome, while broad, may reflect the association between early tracheostomy and decreased ICU LOS and hospital LOS, as the risk of events such as CLABSI and CAUTI is likely mitigated by less time in the hospital. Anand et al had a similar finding, where they also found a significant increase in the rate of “respiratory complications” associated with delayed tracheostomy. Their outcome “respiratory complications” was also a composite variable that included VAP and ARDS. 12
Relationship of Tracheostomy Timing with Mortality
Whether patients underwent early or delayed tracheostomy, there was no difference in mortality rates between the two groups. There have been some studies that have shown mortality benefit with early tracheostomy in critically ill patients. For example, a prospective, randomized trial by Rumbak et al demonstrated that their early tracheostomy group had significantly less mortality compared to the late tracheostomy group (31.7% vs 61.7%; P < .005). However, the study population was patients who developed respiratory failure after medical illness, rather than traumatic injury like in our study population. 13 One study by Anand et al also used the TQIP database to examine mortality in patients undergoing tracheostomy after OCF. Unlike our population, this study did not exclude patients with significant injuries in addition to cervical spinal injuries; however, similar to our study, Anand et al did not find any association between time to tracheostomy and mortality (OR, 1.04 [.95-1.49]). 12 In fact, although the ACS Trauma Quality Programs best practice guidelines state that early tracheostomy improves mortality rates, the only study that is cited that showed significant mortality benefit in early tracheostomy was a systematic review and meta-analysis by Mubashir et al; specifically, the mortality benefit was only seen after a subgroup analysis. 14 Ultimately, although we were unable to show any mortality benefit in early tracheostomy, we did demonstrate that there was not a significantly increased risk of mortality in patients undergoing early tracheostomy.
Relationship of Tracheostomy Timing With LOS and Ventilator Days
Early tracheostomy was associated with significantly shorter ICU LOS (17.0 days vs 23.0 days; P < .0001) and hospital LOS (22.0 vs 29.0 days; P < .0001) as well as fewer ventilator days (15.0 vs 29.0 days; P < .0001). These results are consistent with another large study by Anand et al, although they defined early tracheostomy as ≤4 days from index intubation and the late tracheostomy group as >4 days from initial intubation. They demonstrated that early tracheostomy was associated with more ICU-free days (11 days vs 8 days; P = .01) and a shorter hospital LOS (22 days vs 29 days; P = .01). They also evaluated patient ventilation requirements in terms of ventilator-free days and showed a significant difference in their early tracheostomy vs late tracheostomy groups (13 vs 9 days; P = .02). 12 Although Anand et al did report similar outcomes, for hospital LOS, it is more challenging to compare ICU and ventilation requirements, given the different approaches employed between their study and ours. In evaluating different methods of assessing ventilation requirements, Yehya et al wrote that measuring ventilator-free days improves the statistical power of determining the effectiveness of treatment modalities because it is a continuous variable, as opposed to binary variables such as mortality. However, in most studies that employ ventilator-free days as a metric, mortality in a 28 day period is weighted the same as remaining on the ventilator for greater than 28 days. 15 A similar issue arises with our measurement of ventilator days, in that mechanically ventilated patients who die early on in their hospital course are counted as having fewer ventilator days without reflecting the poor outcome. Given the overall low mortality rate of our study, however, we suspect that outcome rarely occurred in our data. Ultimately, there is no doubt that enabling patients to leave the ICU as well as the hospital and move on to rehabilitation contributes to their overall quality of life.
Limitations
There are several limitations that must be acknowledged given the retrospective design of our study as well as the use of the TQIP database. Specifically, in these large databases, there may be missing data as well as error or inconsistency in coding of the variables. Additional limitations in using this database include lack of additional relevant metrics such as number of days requiring sedation, or whether patients underwent an anterior vs posterior approach to their OCF. Location of surgical site infection is not recorded, so we chose to evaluate patients with isolated cervical injuries. Finally, although the early and delayed tracheostomy groups were similar in terms of patient characteristics, it is possible that the patients who underwent early tracheostomy were selected because they were simply less ill at that point in that hospitalization and therefore also less likely to have a prolonged ICU LOS or hospital LOS.
Conclusion
This study supports the TQIP best practice guidelines that tracheostomy, when indicated, should not be delayed for theoretical concern of increased SSI risk. Delayed tracheostomy after cervical fixation in patients with isolated cervical spine injuries is not associated with improved morbidity and is associated with longer LOS in this national database study.
Supplemental Material
Supplemental Material - Delayed Tracheostomy After Cervical Fixation is Not Associated with Improved Outcomes: A Trauma Quality Improvement Program Analysis
Supplemental Material for Delayed Tracheostomy After Cervical Fixation is Not Associated with Improved Outcomes: A Trauma Quality Improvement Program Analysis by Emma M. Kelly, MD, Andrew M. Fleming, MD, Emily K. Lenart, DO, Isaac W. Howley, MD, Peter E. Fischer, MD, Andrew J. Kerwin, MD, Dina M. Filiberto, MD, and Saskya Byerly, MD in The American Surgeon.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
Supplemental Material
Supplementary material for this article is available on the online.
References
Supplementary Material
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