Early versus Late Tracheostomy in Patients with Acute Brain Injury: Importance of SET Score.

Introduction: Patients with acute brain injury presents are unique subset of neurocritical care patients with its long-term functional prognosis difficult to determine. They often have long intensive care unit (ICU) stay and presents as challenge to decide when to transfer out of ICU. This prospective study aims to assess the benefits of early tracheostomy in terms of ICU-length of stay (ICU-LOS), number of days on ventilator (ventilator days), incidence of ventilator-associated pneumonia (VAP), and mortality rates. Materials and
Methods: After institutional ethical clearance, 80 patients were randomized into two groups: Group A, early tracheostomy group (tracheostomy within 3 days of intubation) and Group B, standard of care group (tracheostomy after 10 days of intubation: late tracheostomy). A cutoff of 10 in the SET score was used in predicting need of early tracheostomy; both groups were compared with respect to ICU-LOS, number of ventilator days (ventilation time), need of analgesia and sedation, incidence of VAP, and mortality data.
Results: Both the groups were comparable in terms of demographic profile and various disease severity scores. ICU-LOS was 14.9 ± 3.6 days in Group A and 17.2 ± 4.6 in Group B. The number of days on ventilator and incidence of VAP was significantly lower in Group A as compared to Group B. There was significantly lower mortality in Group A subset of patients in ICU.
Conclusion: SET score is a simple and reliable score with fair accuracy and high sensitivity and specificity in predicting need of tracheostomy in neurocritical patients. A cutoff of 10 in the score can be reliably used in predicting need of early tracheostomy as in few other studies. Early tracheostomy is clearly advantageous in neurocritical patients, but has no advantage in terms of long-term mortality rates. Copyright:

INTRODUCTION

Acute brain injury patients are a unique subset of neurocritical patients in whom long-term functional prognosis is difficult to determine. These patients present a huge burden on already crunched intensive care unit (ICU) bed availability as they have longer stay. With uncertain neurological outcome, there is always a tendency to shift these patients outside ICU for long-term management. Most of the patients require endotracheal intubation for airway protection as well as mechanical ventilation as intracranial pressure lowering method. The prognosis of stroke patients requiring ICU management and mechanical ventilation was suggested to be generally poor by with reported mortality rates ranging between 40% and 80%. Because the most frequent extracerebral complications of neurological ICU patients are respiratory, measures to improve airway and ventilation management have the potential to improve outcome.[1]

Tracheostomy has been performed in increasing numbers in such patients due to various advantages such as airway protection against aspiration, greater patient comfort, reduced need of sedation, improved oral hygiene, more effective secretion suctioning, and easier weaning. There had been earlier studies advocating tracheostomy as it reduces ICU length of stay (LOS) as well as lesser number of days on ventilator. It facilitates earlier weaning from mechanical ventilation and decreases complications of prolonged intubation.[23]

The beneficial effect of early tracheostomy is still conflicting with very few data available. Various observational studies in neurocritical patients suggested that earlier tracheostomy is associated with improved clinical outcome and reduced hospital stay.[4] It is still unclear whether and when ventilated patients with ischemic or hemorrhagic stroke should obtain a tracheostomy, and to recognize the need to tracheostomize these patients is a daily dilemma. This prospective study aims to assess the benefits of early tracheostomy in neurocritical patients on ventilator in terms of ICU-LOS (ICU-LOS), number of days on ventilator (ventilator days), incidence of ventilator-associated pneumonia (VAP), and mortality rates.

MATERIALS AND METHODS

This prospective randomized study was conducted after obtaining approval from the Institutional Ethical Committee vide letter No. 1745/IEC/IGIMS/2020 dated 28/09/2020 in our ICU at a tertiary care teaching center. This research was done following the ethical principles for medical research involving human subjects according to the Helsinki Declaration 2013 over a period of 12 months (November 2020 to October 2021). Written informed consent from patient's first-degree relative was obtained for each patient for participation in the study and use of the patient data for research and educational purposes; 80 patients were randomized into two groups of 40 each: Group A, early tracheostomy group (tracheostomy within 3 days of intubation) and Group B, standard of care group (tracheostomy after 10 days of intubation: late tracheostomy). This study was adhered to CONSORT guidelines (http://www.consort-statement.org) [Figure 1].

Figure 1

CONSORT flow diagram

Patients included were of both sexes, age group of 40–65 years, admitted for either acute ischemic infarction or nontraumatic intracerebral hemorrhage or aneurysmal subarachnoid haemorrhage (SAH). Only those nontraumatic neurocritical patients who were intubated within 48 h of presenting to our ICU were included in our study. Exclusion criteria were as follows: refusal for early intervention, patients who expired within 48 h of intubation due to devastating neurological insult, patients who had withdrawal of care or dropped out in the middle of the study, patients with preexisting evidence of lung pneumonia confirmed with chest X-ray, and any patient who was treated earlier in other hospital and has been referred to our institute.

Patients were routinely intubated at Glasgow Coma Scale (GCS) score <8, any signs of respiratory insufficiency (arterial PaO2 <60 mmHg and/or PaCO2 >45 mmHg), reduced swallowing/cough reflex, or compromised airway. SET score was calculated within 48 h of admission and those patients having a score of >10 were randomized into any of the two groups. Apart from timing of tracheostomy, both groups received intensive care treatment according to the standard guidelines with respect to ventilatory strategies, weaning protocol, sedation and analgesia requirements, and neurological management. Analgesia and sedation will be routinely applied for pain, agitation, and anxiety and to improve the comfort of the patients. The mode of analgesia and sedation depended on the estimated time for the need of sedation and titrated to sedation scales such as the Sedation and Agitation Scale of 3–4 or a Richmond agitation-sedation scale at 2–4. Serial chest X-ray was done to detect any lung pneumonia in both the subsets of patients.

Both groups were compared with respect to ICU-LOS, number of ventilator days (ventilation time), need of analgesia and sedation, incidence of VAP, and mortality data. Pneumonia diagnosis was based on the clinical criteria. A combination of fever, leukocytosis, and presence of infiltrate in chest radiograph was required to make a diagnosis of VAP and defined as pneumonia after 48 h of ventilation with a clean chest X-ray on presentation; eventually both VAP and other cases of pneumonia were clustered together as “pneumonia.”[5]

SET score

The SET score was initially developed as an in-house screening tool based on tracheostomy predictors identified in several retrospective studies. These were combined under the categories: (1) neurological function, (2) neurological lesion, and (3) general organ function/procedure. For each physiological variable, the worst value in the first 24 h after admission was used to achieve an estimation as early as possible. Dysphagia has to be observed by clinical signs on admission, e.g., by a nonsuccessful swallowing test, impaired saliva handling, or loss/reduction of gag reflex. surgical intervention constitutes a relevant operation, such as decompressive surgery, hematoma removal, or noncranial major surgery, but not external ventricular drain (EVD) or probe placement, thrombectomy, angioplasty for vasospasm, or coiling. Diffuse lesion is defined as a multilocular or widespread affection of the brain such as in SAH, brain edema, multiple infarcts, or hematomas. The definition of hydrocephalus is the distension of ventricles requiring EVD placement. Sepsis is assessed according to the current guidelines of the surviving sepsis campaign. Any combination of selected components of categories 1 and 3 is possible, while some components in category 2 exclude themselves, which results in a total sum ranging between 3 and 37. The early assessment of the SET score within the first 24 h after admission and a score of >10 will be taken for early tracheostomy (within 72 h after intubation) or else late.

The early assessment of the SET score within the first 24 h after admission and a score of >10 will be taken for early tracheostomy (within 72 h after intubation) or else late tracheostomy between day 7 and 14 from intubation if extubation failed.

RESULTS

In our study, we found that both the groups were statistically similar in terms of demographic profile, APACHE score, and SOFA score. GCS score was 6.4 ± 0.6 in Group A and 6.8 ± 1.2 in Group B. Both the groups were statistically comparable in terms of demographic profile and disease severity scores. Majority of patients in both the groups were of ischemic stroke followed by intracranial hemorrhage [Table 1].

Table 1

Demographic profile and disease severity scores

	Group A Early tracheostomy	Group B Late tracheostomy (standard care group)	P
Demography
Age	54.8±6.2	56.2±7.1	0.35
Gender (male:female)	28:12	24:16
SET score	14.8±4.4	15.1±3.7	0.74
GCS score	6.4±0.6	6.8±1.2	0.06
APACHE score	25.2±4.6	26.1±3.3	0.31
SOFA score	6.6±2.4	7.6±3.2	0.11
Diagnosis
Ischemic stroke	20	22
Intra-cranial hemorrhage	14	11
Subarachnoid haemorrhage	6	7

GCS=Glasgow Coma Scale, SOFA=Sequential Organ Failure Assesment Score, APACHE=Acute Physiology and Chronic Health Evaluation, SET=Stroke Related Early Tracheostomy

Patients who were early tracheostomized (within 3 days of intubation) had shorter length of ICU stay (14.9 ± 3.6 days) compared to those who had tracheostomy after 10 days (17.2 ± 4.6 days). This was found to be statistically significant (P = 0.01). The number of days on ventilator was also significantly less in Group A compared to Group B (11.9 ± 3.6 vs. 14.6 ± 4.2 days). It was seen that patients with early tracheostomy were more easily weaned from ventilator as compared to those who had tracheostomy at later stage. They had significantly less ICU stay as well as ventilator days. The incidence of VAP was also significantly less in Group A (14%) as compared to Group B (21.7%). This might be due to ease of suctioning of secretion from airway as well as lesser number of days on ventilator [Table 2].

Table 2

Primary outcome of the study

	Group A Early tracheostomy	Group B Late tracheostomy (standard care group)	P
ICU-length of stay	14.9±3.6	17.2±4.6	0.01
Ventilator days	11.9±3.6	14.6±4.2	0.02
Incidence of VAP (%)	14	21.7

ICU=Intensive care unit, VAP=Ventilator-associated pneumonia

There was significantly increased mortality during ICU stay in Group B as compared to Group A (44% in Group B versus 28% in Group A). However, at 30 days postadmission, mortality rates were comparable in both the groups. This implies that although more patients were transferred out from ICU in Group A, there was no advantages in mortality at 30 days. Sepsis/VAP were more common as causes of ICU mortality in Group B [Table 3].

Table 3

Mortality data of the study

	Group A Early tracheostomy	Group B Late tracheostomy (standard care group)
Mortality data (%)
During ICU stay	14 (28)	22 (44)
At 30 days	26 (52)	28 (56)
Causes of mortality in ICU
Due to primary neurological cause	9	11
Due to sepsis/VAP	4	9
Other causes	1	2

ICU=Intensive care unit, VAP=Ventilator-associated pneumonia

DISCUSSION

The main finding of our study shows that early tracheostomy leads to decreased duration of ICU stay, less ventilator days, and lower ICU mortality in patients, which aided in earlier discharge of patients out of ICU and thus benefitting our healthcare resources by allocating the ICU beds to more needy patients with better functional outcome. Early transfer out of early tracheostomized patient to areas outside ICU is of no benefit over long term as mortality rates in these areas were significantly high.

In a large systemic review and meta-analysis including approximately 2500 patients in each group by Marra et al. in 2021, they concluded that early tracheostomy reduced risk for incidence of pneumonia, ICU LOS, hospital LOS, and duration of mechanical ventilation, but not mortality.[6]

In a meta-analysis comparing early with late tracheostomy in traumatic brain injury patients, de Franca SA and colleagues in 2020 reviewed several studies. The mean time for early tracheostomy and late tracheostomy procedures was 5.59 days and 11.8 days, respectively. A meta-analysis revealed that early tracheostomy was associated with shorter mechanical ventilation duration as well as ICU and hospital stay durations and presented less risk difference for ventilator-associated pneumonia. No statistical difference in mortality was found between the groups.[7]

Alsherbini et al.[8] in a retrospective study compared the SET score between tracheostomy (within 7 days) versus late tracheostomy (after 7 days) and found that the sensitivity for a SET score >10 to predict the need for tracheostomy was 81% with a specificity of 57%. They concluded that performing early tracheostomy was associated with improvement in the ICU median LOS (15 vs. 20.5 days; P = 0.002) and mean ventilator duration (13.4 vs. 18.2 days; P = 0.005) in comparison to late tracheostomy.

Cochrane database systemic review in 2015 included eight studies with a total of 1977 patients allocated to either early or late tracheostomy and found that patients receiving early tracheostomy had lower risk of mortality at the longest follow-up time available (ranging from 28 days to 2 years of follow-up). Results concerning the time spent on mechanical ventilation were not definitive, but suggested benefits associated with early tracheostomy. Two studies show a significantly higher probability of discharge from the ICU at 28 days of follow-up in the early tracheostomy group and no significant differences for pneumonia.[9]

Dunham et al. in 2014 performed a comprehensive literature review to identify all randomized controlled trials assessing the impact of early tracheostomy (within 3–5 days) on severe brain injury outcomes. They found that mechanical ventilation is reduced with early tracheostomy, whereas the incidence of ventilator-associated pneumonia rates remains unchanged.[10]

Bösel et al. in 2013 investigated feasibility, safety, and potential advantages of early tracheostomy. They randomized patients to either early tracheostomy (within day 1–3 from intubation; early) or to standard tracheostomy (between day 7 and 14 from intubation if extubation could not be achieved) and found no differences with regard to the LOS in the ICU although use of sedatives was less. ICU mortality and 6-month mortality were lower in the early group.[11]

Our findings are consistent with many recent studies regarding lesser duration of ICU stay, lesser ventilation time, as well as decreased incidence of VAP in early tracheostomy group. However, there was no benefit in terms of overall mortality rates.

Our study had number of limitations including small sample size, which limits the generalizability of results. A significant number of patients who had late tracheostomy had a failed weaning/extubation trial, which might have affected the outcome.

CONCLUSION

SET score is a simple and reliable score with fair accuracy and high sensitivity and specificity in predicting need of tracheostomy in neuro-critical patients. A cutoff of 10 in the score can be reliably used in predicting need of early tracheostomy as in few other studies. This study shows benefits of early tracheostomy in neurocritical patients. However, a larger multicentric study with larger sample size will be beneficial to prove the utility of SET score and benefits of early tracheostomy.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.