ORIGINAL ARTICLE |
https://doi.org/10.5005/jp-journals-10030-1429 |
Comparison of Extubation vs Tracheostomy in Patients Ventilated for at Least 14 Days: A Retrospective Observational Study
1,4Department of General Surgery, Trauma Surgery Unit, Wolfson Medical Center, Holon, Israel
2,3,5,11,12Department of Anesthesiology and Critical Care, Wolfson Medical Center, Holon, Israel
6Department of General Surgery, Sheba Medical Center, Ramat Gan, Israel
7Department of Emergency Medicine and Intensive Care, The Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
8–10Department of General Surgery, Wolfson Medical Center, Holon, Israel
Corresponding Author: Adam L Goldstein, Department of General Surgery, Trauma Surgery Unit, Wolfson Medical Center, Holon, Israel, Phone: +972524464616, e-mail: adamg.barefoot@gmail.com
Received: 12 August 2023; Accepted: 09 October 2023; Published on: 30 December 2023
ABSTRACT
Aims and background: Prolonged mechanical ventilation is frequently required in severely ill patients. The goal of the study is to describe the outcomes of critically ill patients who are mechanically ventilated for >14 days and the effect of late tracheostomy vs late extubation on their outcome.
Patients and methods: A retrospective descriptive study was conducted at a single intensive care unit (ICU) at an academic tertiary medical center. All patients were admitted to the ICU on mechanical ventilation for >14 days over a 5-year period (1st January 2016–31st December 2020). The main outcome measures analyzed were length of ICU stay and inhospital mortality.
Results: A total of 179 patients were hospitalized in the ICU for >14 days. Of these, 36 were mechanically ventilated for greater than 14 days, 26 of them eventually underwent a tracheostomy, and 10 were extubated. As compared to the extubated patients, the cohort receiving the tracheostomy all had significantly longer ICU lengths of stay (27 vs 47.5 days, p-value 0.0017), length of hospitalization (29.5 vs 52 days, p-value < 0.05), and total days of mechanical ventilation (21.5 vs 46 days, p-value < 0.05). There was no significant difference between the days of endotracheal (ET) intubation, ventilator-associated pneumonia (VAP), albumin (Alb) and hemoglobin (Hb) levels, ICU death, or discharge. Undergoing tracheostomy resulted in a longer ICU/hospitalization without a change in overall inhospital mortality.
Conclusion: Performing late tracheostomy after 14 days may prolong hospitalization without improving inhospital survival.
Clinical significance: All efforts should be made to determine the need for, and subsequently perform, a tracheostomy. For whatever reasons, this is delayed beyond 14 days, the team should reevaluate the benefit to the patient and potential for possible ET extubation from mechanical ventilation.
How to cite this article: Goldstein AL, Said A, Elisha ID, et al. Comparison of Extubation vs Tracheostomy in Patients Ventilated for at Least 14 Days: A Retrospective Observational Study. Panam J Trauma Crit Care Emerg Surg 2023;12(3):110–115.
Source of support: Nil
Conflict of interest: None
Keywords: Critical care, Late extubation, Late tracheostomy, Mechanical ventilation
INTRODUCTION
Timely extubation, or tracheostomy, for patients with endotracheal (ET) intubation in the intensive care unit (ICU) is the generally accepted standard of care. This is in order to avoid the potentially fatal and morbid complications of prolonged intubation. These complications include patient discomfort, ventilator-associated pneumonia (VAP), pressure ulcers, laryngeal injury, sinusitis, and prolonged use of sedation. Despite this common practice, there remains a lack of data in order to form clear guidelines.
Decades of literature show that between 5 and 20% of ET extubations may fail and require reintubation.1 Nevertheless, in any ICU setting, there are groups of patients who are difficult/unable to be extubated, fail extubation, or, because of logistics, remain ET intubated for a prolonged period of time. In regard to performing tracheostomy, excluding neck trauma or as part of otorhinolaryngology reconstruction, there are usually two pathways. First, an extremely early tracheostomy for those with extensive chest and/or multitrauma (and/or severe neurotrauma) whom the treating team believes will be unable to be extubated and therefore performs an early tracheostomy once the damage control stage is completed, usually within 3–5 days. Second is the group of ICU patients who are already ET intubated for 7–14 days, and the treating team does not believe that they will be able to undergo successful extubation in the near future. The timing of performing a tracheostomy remains controversial and variable depending on local practice rather than evidence-based guidelines.2 Some studies suggest a benefit when a tracheostomy is performed within 7 days;3 other studies have shown that there is no overall survival benefit, no change in length of hospitalization, or decrease in pneumonia rates between an early and late tracheostomy.4
There are a wide range of reasons the individual patient is unable to be extubated immediately following surgery or in the days following intubation. Reasons include instability, prolonged critical illness, need for follow-up surgery, fluid overload, and generalized weakness/deconditioning. Most ICUs, including ours, have specific weaning protocols that have been shown to improve the chance of successful extubation. For example, when comparing premature, delayed, or optimal weaning (based on established protocols), premature and delayed weaning have been found to have worse clinical outcomes with fewer ventilator-free days.5–11 Reintubation (after premature weaning) and delayed extubation are associated with increased mortality and cost.1,12 Failed extubation (those needing reintubation in the day/days following extubation) increases ICU length of stay (LOS), ICU mortality, and overall cost.12 Despite heterogeneity in institution protocols, most weaning protocols include cardiovascular variables, respiratory variables, and neurological variables,13 together with airway mechanical factors such as the cuff-leak test.14 These weaning protocols are established to best evaluate when a patient is clinically ready, with the highest chance of success. Questions arise when the patient does not meet the weaning protocol, such as when is the optimal time to perform a tracheostomy. There are a wide range of recommendations, which vary depending on the etiology of the initial injury (i.e., neurological trauma, polytrauma, elective surgical cases, severe lung disease). Due to the difficulty of performing blinded randomly controlled studies and the heterogeneity of these patients, there remains a paucity of evidence-based guidelines.
The majority of centers recommend performing a tracheostomy after 7–14 days of ET intubation if the patient is unable to be weaned.2,4,7 Nevertheless, even if an ICU gives optimal care, there always remains a small percentage of patients who remain ET intubated for >14 days prior to extubation. Due to this cohort of patients not belonging to commonly accepted pathways of care, we aim to compare the outcomes of these patients (mortality, length of ICU/hospitalization) against the effect of performing a late (>14 days) tracheostomy. We aim to evaluate the effectiveness in regard to outcome when performing a tracheostomy after 14 days of ET intubation.
PATIENTS AND METHODS
A retrospective analysis over a 5-year period (1st January 2016–31st December 2020) was conducted from the general ICU (medical/surgical/trauma) at a single tertiary hospital in central Israel. All patients over the age of 18 who were intubated for 14 days or longer were included in this study. Excluded from this study were cardiac surgery patients (a separate ICU), neurosurgical patients, and those in which it was determined that there was a dismal prognosis and proceeded with only palliative care. None of the cohort had a previous tracheostomy.
Demographic data and diagnosis were obtained. Data was obtained from our computerized medical record system. Number of days with ET intubation, without ET intubation, with tracheostomy, hospitalization, and ICU stay were all recorded. Complications such as reintubation, VAP, septic shock, multiple surgeries, and the need for continuous venovenous hemofiltration (CVVH) were all analyzed. Hemoglobin (Hb) and albumin (Alb) for hospital days (HDs) 1 and 14 were obtained, together with outcome measures such as ICU death, hospital death, discharge to another facility, or discharged home. Quality control procedures included reviewing the data extracted by two different senior physicians. Once the data was obtained, any identifiable information (the patient's name and identification number) was replaced with a numeric code (patient 1, 2, 3…).
Weaning protocols varied with individual attendings, yet basic standards of care remained universal within the ICU of this cohort. These included an X-ray without major pathology, the patient not sedated and following commands, the patient with the strength to lift his head from the bed, normal arterial blood gasses with FiO2 ≤ 40%, minimal ventilator settings, and maintaining of breathing comfort without CO2 retention during these minimal ventilator settings, and a positive leak test.
Statistical analysis was completed with Numerical Calculation and Statistical Software (NCSS) 2022 Statistical Software used (2022, LLC. Kaysville, Utah, United States of America). Continuous variables were reported as median and interquartile range (IQR), together with the use of the Mann–Whitney test. A Kaplan–Meier curve was used to demonstrate survival and a log-rank test was used to compare the two groups in which all were two-sided. Categorical variables were summarized as frequency and percentage using the Fisher exact test with a significant p-value of <0.05.
The internal review board of the Wolfson Medical Center approved this study in accordance with the ethical standards guidelines of the Helsinki Declaration of 1975 (WMC20-32 September 2022).
RESULTS
Over a 5-year period between 2016 and 2020, we looked at the 179 patients who were admitted for longer than 14 days. Within this cohort, a total of 36 had prolonged mechanical ventilation for >14 days. These 36 patients were retrospectively divided into two groups—26 patients who proceeded to late tracheostomy (group II) and a second smaller group of 10 patients who had undergone late extubation (group I). The demographics, basic laboratory trends, and intubation course of the patients are summarized in Table 1. There was no difference in gender or age between the two groups. The APACHE Score was higher in group I (mean of 23.7 vs 15.8), yet there was a large number of APACHE scores missing from group II, so this must be interpreted with caution. There was no significant difference between the number of days with ET intubation (mean of 24.4 vs 26 days, p-value 0.296) or number of days not intubated (mean of 4.9 vs 8.9, p-value 0.776). For group number II, there was a significantly longer ICU LOS (mean of 30 vs 50 days, p-value 0.0017), hospital LOS (mean of 33 vs 57 days, p-value < 0.05), and total days of mechanical ventilation (mean of 23.4 vs 47.6 days, p-value < 0.05). There were no differences between Alb levels or Hb levels on HDs 1 and 14 between the two groups (mean Alb HD 1 2.9 vs 3.0, HD 14 2.3 vs 2.4, with p-values 0.764 and 0.915, respectively. Mean Hb HD 1 11.3 vs 12.1, HD 14 9.5 vs 9.5, with p-values 0.416 and 0.929, respectively). In group II, for those receiving a tracheostomy, the average day until a tracheostomy was 30.7, and the average length of time with a tracheostomy was 21 days.
| ET intubation only10 | ET intubation + tracheostomy26 | p-value | |
|---|---|---|---|
| Gender—m/f (%) | 5/5 (50/50) | 19/7 (73/27) | 0.247 |
| Age (years) (mean/median) | 69.8/80 | 64.5/63.5 | 0.416 |
| Apache score upon admission(mean/median) | 23.7/24 | 15.8/17* | 0.044* |
| ICU LOS (day)(mean/median) | 30/27 | 50/47.5 | 0.0017 |
| Hospital LOS (day)(mean/median) | 33/29.5 | 57/52 | <0.05 |
| Days ET intubation(mean/median) | 24.4/21.5 | 26/25.5 | 0.296 |
| Total length mechanical ventilation (day)(mean/median) | 23.4/21.5 | 47.6/46 | <0.05 |
| Failed extubation attempts (average) | 0.9 | 0.5 | 0.338 |
| Days not mechanically ventilated(mean/median) | 4.9/5 | 8.9/5.5 | 0.776 |
| Mean albumin levels(HD 1/14) | 2.9/2.3 | 3.0/2.4 | 0.764/0.915 |
| Mean Hb levels(HD 1/14) | 11.3/9.4 | 12.1/9.5 | 0.416/0.929 |
Alb, albumin; ET, endotracheal intubation; Hb, hemoglobin; HD, hospital day; LOS, length of stay; *APACHE score—in group II there was a significant number of missing scores; Bold values indicate that <0.05 is significant
The most frequent diagnosis of the entire cohort was respiratory failure and failure to thrive with ICU myopathy, followed by abdominal sepsis, pneumonia, and then pulmonary embolism, trauma, and nonabdominal sepsis, all with the same frequency. The only significant difference between the two groups regarding ICU complications was the need for CVVH (60 vs 19%, p-value 0.039) in the group with only ET intubation. The other ICU complication parameters had no significant differences. These included VAP (30 vs 58%, p-value of 0.264), septic shock (70 vs 46%, p-value 0.274), and the need for multiple surgeries (0 vs 23%, p-value 0.156). The initial diagnosis and ICU course are summarized in Table 2.
| ET intubation only10 | ET intubation + tracheostomy26 | p-value | |
|---|---|---|---|
| Diagnosis | |||
| Abdominal sepsis | 4 | 5 | |
| Nonabdominal sepsis | 2 | 0 | |
| Pneumonia | 1 | 7 | |
| Pulmonary embolism | 2 | 0 | |
| Trauma | 0 | 2 | |
| Respiratory failure | 1 | 12 | |
| CVVH | 6 (60%) | 5 (19%) | 0.039 |
| VAP | 3 (30%) | 15 (58%) | 0.264 |
| Septic shock | 7 (70%) | 12 (46%) | 0.274 |
| Multiple surgeries | 0 (0%) | 6 (23%) | 0.156 |
CVVH, continuous venovenous hemofiltration; VAP, ventilator-associated pneumonia; Bold indicates statistical significance
In regard to outcome, 30% of the group I patients were discharged home and none to a rehabilitation facility. In group II, 15% of the patients were transferred to a rehabilitation facility, and 35% were discharged home. The overall inhospital mortality of the cohort (all patients with an ET intubation with or without a tracheostomy) was 55%. Seventy percent of group I patients died in the hospital compared to 50% of group II patients. There were no significant differences between overall death (in-ICU or inhospital) (p-value 0.274) or discharge (p-value 0.508). These outcomes are summarized in Table 3. There was no significant correlation between days of ET intubation and inhospital death (p-value 0.143) for any of the patients. There was also no significant correlation between the number of days with a tracheostomy and the inhospital death (p-value = 0.355). Yet there was a significant difference in the timing of death between those not receiving a tracheostomy and those receiving a tracheostomy (p-value 0.0024). Figure 1 shows the Kaplan–Meier curve demonstrating that the patients receiving a late tracheostomy survived longer initially, yet eventually, the mortality rate equalized. Therefore, this shows that the length of hospitalization was extended for group II, yet without an improvement in survival. The Alb levels at days 1 and 14 had no significant impact on death (p-value = 0.899 on day 1 and p-value = 0.547 on day 14), nor did the Hb levels (p-value 0.86 on day 1 and p-value 0.515 on day 14).
| ET intubation only10 | ET intubation + tracheostomy26 | p-value | |
|---|---|---|---|
| ICU death n (%) | 7 (70%) | 12 (46%) | 0.274 |
| *Total inhospital death | *7 (70%) | *13 (50%) | *0.456 |
| Discharge n (%) | |||
| Rehabilitation | 0 | 4 (15%) | 0.508 |
| Home | 3 (30%) | 9 (35%) |
*Significance of p < 0.005
Fig. 1: Kaplan–Meier curve
DISCUSSION
The dynamic nature of the ICU, together with the critically ill patient population and multiple variables affecting outcomes, creates an environment that is difficult to predict or control by guidelines and treatment protocols. This is especially true for predicting the ability to safely and efficiently perform ET extubation and the optimal timing for performing a tracheostomy. Even in the most advanced, evidence-based ICUs, there will always remain a small cohort of patients who do not follow the standard path and remain with an ET intubation for a prolonged period of time. This may be due to medical reasons—stability, multiple surgeries, infectious or logistical issues, such as ability to perform tracheostomy, manpower issues (national holidays, natural disaster, conflict), changes in providers’ different philosophies (one attendant thinking different than the other, handoffs, weekends), or familial conflict regarding the continuation of care. Due to the numerous confounding factors and despite well-established guidelines and recommendations, there will always remain this cohort of patients. Here, we have described our cohort of these patients, together with the effect of performing a late tracheostomy.
There is no clear definition of prolonged ET intubation. Even though ET intubation has been around for over 100 years, into the early 1960s, there were still questions about the safety of ET intubation longer than 24 hours.15 At this time, reports of “prolonged” intubation were still mostly case reports. Even into the late 1980s, prolonged was considered >4 days.16 As the amount of research on the timing of tracheostomy increased, definitions of early vs late tracheostomy were established for research protocols and not from evidence-based research. This is partially due to the widely varying nature of the patient population (i.e., neurotrauma, multitrauma, medical), and the insufficiency of data on the subject. Landmark studies such as the TracMan randomized trial defined early tracheostomy as 4 days or less and late as anytime after 10 days of ET intubation.17,18 Other studies have described early tracheostomy as ≤3 days and late as >7 days,19 and meta-analysis have used extremely wide ranges to define early (between 1 and 8 days) and late (6–28+ days) tracheostomy.20 Due to these poorly defined limitations, there is a lack of consensus and clear evidence-based recommendations on safety of prolonged intubation and timing of tracheostomy.
There are clear advantages of evolving from an ET intubation to a tracheostomy when the patient is unable to be safely liberated from mechanical ventilation. Yet even these seemingly obvious advantages lack evidence-based research and remain controversial. For example, direct damage to the upper airway/larynx is probably the most proven negative result of ET intubation that is resolved by tracheostomy. Yet the clear clinical significance of this remains to be proven and is difficult to qualify. Recent meta-analyses have shown a prevalence of 83% on any severity of injury and a range of 13–31% of severe injury with an average of 8.2 days intubated.21 Yet other studies have reported 41% of any degree of vocal cord injury, without correlation with the number of days with ET intubation (range 2–28 with a mean of 9.1) or size of the ET tube.22 This data suggests that most probably all patients would have some level of damage at 14 days, as in our cohort, but there is no data showing if tracheostomies eventually improve or change the morbidity outcomes of the damage. Also, there are no studies looking at confounding factors, such as nutrition status of the patient (catabolic or anabolic state?) and amount of sedation, and their effect on laryngeal damage. Despite these benefits, the invasive nature of performing a tracheostomy in this severely ill cohort needs to be taken into consideration. Complications when performing a tracheostomy, either percutaneous or open, have been reported in some reports as high as 10%,5,6 and in other reports as low as 0–0.5%.7
Increased patient comfort, decreased days sedated, and earlier return to autonomy have all been reported as benefits to tracheostomy. This is seemingly stating the obvious, and there is some data to support this despite difficulties in quantifying, together with the many possible confounding factors.23 One study was able to confirm decreased days of sedation together with a quicker return to autonomy.24 Nevertheless, this is highly labor-intensive, and staff shortage is a limiting factor.
Another highly studied subject regarding the effect of performing a tracheostomy is VAP. Recent data has shown a significant decrease in VAP rates with an early tracheostomy, decreased days on mechanical ventilation, and decreased ICU stay.25,26 Other recent data, including a Cochrane review, has shown no difference in VAP rates.20,27 This data is difficult to compare, though, because of the variation in cutoff day of tracheostomy or the definition of early tracheostomy. The authors could not find studies comparing results of specific days (i.e., what happens if a tracheostomy is performed exactly on day 4 or 14). These referred studies also fail to show a difference in early and/or late mortality and in the overall hospital stay.18,20,25 A major bias when looking at the length of mechanical ventilation is that many patients undergoing tracheostomy might be discharged to rehabilitation centers on mechanical ventilation, which is not always reported.
There are also economic factors secondary to performing a tracheostomy. One theoretical economic advantage is a decrease in length of intensive care stay, yet this is difficult to quantify due to a large number of variables,8 and remains to be unproven. This potential economic benefit might also be negated by the increased number of patients being discharged with tracheostomies to chronically ventilated facilities with the need for prolonged mechanical ventilation.9,10 Hence, a potential overuse of tracheostomy might, in the long-term, have a negative economic benefit to the overall healthcare system (not the individual hospital).
Of interest, our results demonstrate the opposite of most of the current data. We showed that if a patient has already been ET intubated for over 14 days, and then a tracheostomy is performed, the length of ICU stay, mechanical ventilation, and total hospitalization days are all significantly increased. There was no significant difference between the two groups’ length of ET intubation or days not ET intubated (i.e., days not intubated between extubation and need for reintubation). These elongations of ICU and hospital state in the group undergoing late tracheostomy correlate with the initially prolonged survival, which ends with the same inhospital mortality rate of the group that did not receive a tracheostomy. We also did not find a significant difference in the rate of VAP between the two groups. Both groups were also similar regarding age, sex, Alb, and Hb levels.
The nonstatistical differences between the two groups of Alb and Hb on days 1 and 14 are important and representative of similar nutritional status. There is a clear association between nutritional status/muscle mass and failure to extubate.28,29 Both our cohorts had clinically low levels of these proteins on both days 1 and 14. Therefore, signifying the clinical severity of our patient population and a potential global indicator that might have improved ability to extubate and overall survival within both groups.
There are clearly many limitations and confounding factors to this study. The most prominent are the heterogeneous primary pathologies, a small size, and that the study is coming from a single center. Larger multicentered studies are needed to look at this group of critically ill patients. Therefore, this study needs to be seen as a trend and a possible stepping point for further larger studies in this neglected population.
CONCLUSION
Our study looks at a very unique yet common cohort of patients. Despite the limitations of this study, we think it is important to acknowledge this group of patients and make all efforts to avoid arriving at the situation where a tracheostomy is undertaken late in the patient’s ICU course.
There is a need for further studies that will help form more strict guidelines for when to perform a tracheostomy and possibly advocate to be more aggressive with timing when deciding to perform a tracheostomy. Larger investigations, similar to this study, might be able to determine that it is futile to perform a tracheostomy after a certain point. In conclusion, performing a tracheostomy after 14 days of prolonged hospitalization without improving inhospital survival.
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