key: cord-0031307-1lr84jrn authors: Hallan, David R; Simion, Christopher; Rizk, Elias title: Early Versus Late Tracheostomy in Spontaneous Intracerebral Hemorrhage date: 2022-04-12 journal: nan DOI: 10.7759/cureus.24059 sha: f695cfb3ab7a91b6690dcbe2e616f2d0f4530c49 doc_id: 31307 cord_uid: 1lr84jrn Introduction: Recent literature supports early tracheostomy (<=7 days) over delayed tracheostomy (>7 days-3 months) to improve overall clinical outcomes for patients admitted with an acute head injury. There is conflicting evidence for the same in hemorrhagic stroke. Using a multi-institutional database, we explored this question in nontraumatic spontaneous intracerebral hemorrhage (sICH) patients. Methods: We used a de-identified database network (TriNetXʼs Research Network) to gather information on early tracheostomy (<=7 days) and late tracheostomy (>7d-3 months) in sICH patients. After accounting for the most common comorbidities, we explored the impact of this intervention on multiple patient outcomes including intensive care unit (ICU) length of stay, pneumonia, and mortality at 30, 90, and 365 days. Results: After propensity score matching, a total of 1210 patients were identified for both early tracheostomy (cohort 1) and late tracheostomy (cohort 2) cohorts. The 30-day survival rate was 0.9287 in cohort 1 vs 0.9536 in cohort 2, with a risk difference of 2.39% (95% confidence interval (CI) 0.557%-4.23%; relative risk (RR) 1.54, 95% CI (1.10-2.15); OR 1.577, 95% CI (1.11-2.24); p = 0.006). The 90-day and 365-day end-point survival rates were not statistically different between cohorts. ICU level of care codes were billed an average of 9.76 (SD 8.964) times in cohort 1 vs 14.618 (SD 11.851) in cohort 2 (p<0.0001). At 365 days, there were no differences between the two groups for pulmonary embolism, myocardial infarction, deep venous thrombosis, palliative care consultation, and percutaneous endoscopic gastrostomy tube placement. Cohort 1 had decreased incidence of pneumonia with 665 (54.95%) patients compared to cohort 2 with 725 (59.91%) (RR 0.917, 95% CI (0.856-0.983), OR 0.816, 95% CI (0.695-0.95), p = 0.013). Conclusion: Early tracheostomy in sICH patients was associated with decreased pneumonia risk, decreased length of ICU care, and no difference in mortality at 90 and 365 days. Spontaneous intracerebral hemorrhage (sICH) is defined as nontraumatic bleeding into the brain parenchyma which can extend to the ventricles and subarachnoid space [1] . It is the second most common subtype of stroke [2] , responsible for case-fatality ranges of 35% at 7 days to 59% at 1 year [3, 4] . Those who recover are often left with a disability; less than 40% of patients regain functional independence [2] . Inhospital complications are known to be correlated with increased length of stay. Most available stroke data concerning in-hospital complications pertain to ischemic stroke, with few focusing on sICH [5] . Prior literature by Rizk et al. found a complex relationship with tracheostomy timing and outcomes in neurotrauma patients that suggested a strategy of early tracheostomy (< 7 days) resulted in better overall clinical outcome, including functional outcome, versus late tracheostomy [6] . Given this, we sought to observe whether a similar strategy in nontraumatic sICH would benefit from early tracheostomy. This was a retrospective comparative case-control study. We used a de-identified database network (TriNetX) to retrospectively query via the International Classification of Disease (ICD-10) and current procedural terminology codes to evaluate all patients with a diagnosis of spontaneous intracerebral hemorrhage who received a tracheostomy within 7 days (cohort 1) versus 8 days-3 months (cohort 2). Data came from 57 healthcare organizations (HCOs) spanning six countries (the United States, United Kingdom, Germany, Italy, Israel, and Singapore). Data includes demographics, diagnoses, medications, laboratory values, genomics, and procedures. The identity of the HCOs and patients is not disclosed to comply with ethical guidelines against data re-identification. Because of the databaseʼs federated nature, an Institutional Review Board (IRB) waiver has been granted. The data is updated daily. Previous literature informed our use of this database and its validity, and the networkʼs exact details have been previously described [7] [8] [9] [10] . The diagnosis was based on ICD-10 codes and procedural codes via Common Procedural Terminology (CPT) After propensity score matching, a total of 1,210 patients were identified for both early tracheostomy (cohort 1) and late tracheostomy (cohort 2) cohorts. Age at index was 50.31+-18.69 years and 50.13+-19.14 years for cohorts 1 and 2, respectively. 65.54% of cohort 1 were male, versus 67.36% in cohort 2. 58.099% vs 59.256% of patients were white, 22.314% vs. 21.322% were black or African American, and 17.190% vs. 17.273% were of unknown race. Baseline demographics and characteristics are shown in Table 1 . There is a debate over the best time to perform a tracheostomy on a ventilated patient with a severe stroke. In 2013, the Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT) trial examined patients with severe ischemic or hemorrhagic stroke who were expected to be on a ventilator for at least two weeks, and randomized patients into early versus late tracheostomy. They found that early tracheostomy did not decrease the average length of ICU stay, but did find decreased ICU mortality in patients with early tracheostomy, as well as decreased 6-month mortality [11] . This trial's findings were in contradistinction to many previously reported findings of decreased ICU length of stay with early tracheostomy [6] . For example, the 2020 Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study looked at early (<=7 days) versus late (>7 days) tracheostomy in traumatic brain injury patients, and found that patients with late tracheostomy were more likely to have a worse neurological outcome, as well as a longer length of stay [12] . Likewise, a 2020 multicenter analysis looking at patients with myasthenic crisis found that early tracheostomy (performed before 10 days) was associated with shorter ventilation time as well as shorter duration of ICU stay for these patients as compared to late tracheostomy [13] . Similarly, a 2020 meta-analysis of early tracheostomy in severe traumatic brain injury patients showed that early tracheostomy reduced nosocomial adverse events, and allowed for early rehabilitation in these patients and early discharge, with associated reduced hospital and ICU length of stay. Our results demonstrate that early tracheostomy (<= 7 days) versus late tracheostomy (>7 days) is associated with decreased length of ICU stay, decreased pneumonia/pneumonitis risk, but no improvement in survival outcomes at 90 and 365 days. There was no significant difference between groups for PE, MI, or DVT. Our analysis was not without limitations. The major limitation of this study was that it was retrospective in nature. Furthermore, due to the nature of the database, we were unable to collect patient-level data on specific outcomes. The use of early vs. late tracheostomy timeline of 7 days, though arbitrary, is based upon the definitions in the literature and was established prior to the study. A meta-analysis indicated that studies indicating the endpoint of 7 days between early and late designation had better outcomes than studies that made the designation 14 or 21 days [15] . The data collected was for billing purposes, not for clinical use, and thus much clinical information is missing. There is a risk of selection bias in our cohort given that more critical patients will receive more intensive interventions earlier in their hospital course. In The critical care management of spontaneous intracranial hemorrhage: a contemporary review Intracerebral haemorrhage Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association The epidemiology of intracerebral hemorrhage in the United States from 1979 to Complications of intracerebral haemorrhage Impact of tracheostomy timing on outcome after severe head injury Using a federated network of real-world data to optimize clinical trials operations Cerebral venous thrombosis and portal vein thrombosis: a retrospective cohort study of 537,913 COVID-19 cases. EClinicalMedicine. 2021 6-month neurological and psychiatric outcomes in 236 379 survivors of COVID-19: a retrospective cohort study using electronic health records Outcomes of COVID-19 in patients with rheumatoid arthritis: a multicenter research network study in the United States Stroke-related early tracheostomy versus prolonged orotracheal intubation in neurocritical care Trial (SETPOINT): a randomized pilot trial Tracheostomy practice and timing in traumatic brain-injured patients: a CENTER-TBI study Early tracheostomy is associated with shorter ventilation time and duration of ICU stay in patients with myasthenic crisis-a multicenter analysis Early tracheostomy in severe traumatic brain injury patients: a meta-analysis and comparison with late tracheostomy Timing of tracheostomy in patients with prolonged endotracheal intubation: a systematic review addition, some misidentification is inevitable in database studies. sICH is associated with high mortality rates, and those who recover are often left with a disability. Many of these patients require mechanical ventilation and eventual tracheostomy. In this study, we found that early tracheostomy in patients with sICH is associated with decreased pneumonia risk, decreased length of ICU care, and no difference in mortality at 90 and 365 days. This suggests that pursuing early tracheostomy in patients with sICH who are requiring mechanical ventilation without successful weaning may be an effective strategy for decreasing the ill effects of ventilator dependence, reducing hospital costs, and reducing inhospital complications. Human subjects: Consent was obtained or waived by all participants in this study. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.