Early Tracheostomy in Ventilated Stroke Patients

Study Overview
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Brief Summary
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Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. This study investigates the potential benefits of early tracheostomy in ventilated critically ill patients with ischemic or hemorrhagic stroke.

Detailed Description
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Background: Tracheostomy is a common procedure in critical care patients. Advantages of a short tracheal tube compared to a long orotracheal one are the avoidance of laryngeal lesions and sinusitis, facilitation of nursing care and physiotherapy and the reduction of analgosedatives. The optimal point in time for tracheostomy is still unknown, but it is commonly done not later than 2-3 weeks and after one or several failed extubation trials. Studies in different sets of critical care patients have suggested additional advantages of early tracheostomy: less pneumonias and other complications, more patient comfort, less analgosedation, shorter duration of ventilation and of ICU stay. These questions have not been looked at in non-traumatic neurocritical care patients, although these might have a special weaning benefit by early tracheostomy, being mainly compromised in securing their airway, but not in breathing. Method: Non-traumatic Neurocritical care patients with ischemic strokes, intracerebral hemorrhage or subarachnoid hemorrhage so severly affected that 2 weeks of ventilation need are estimated, are principally eligible for the study. After randomization, one group receives tracheostomy within the first 3 days after intubation. The other group stays orotracheally intubated and is either weaned and extubated or receives tracheostomy within 7 to 14 days after intubation. Tracheostomy is done as percutaneous dilatation by neurologists.

Official Title
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Stroke-Related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical Care Trial

Conditions
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Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage

Intervention / Treatment
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* Procedure: Early Tracheostomy
* Procedure: Late Tracheostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years informed consent from legal representative non-traumatic cerebrovascular disease Estimated ventilation need for at least 2 weeks Exclusion Criteria: age < 18 years informed consent not obtainable intubated for more than 3 days death within 3 weeks likely severe chronic pulmonary disease severe chronic cardiac disease emergency situation intracranial pressure difficult to control need for a permanent tracheostoma contraindications for dilatative tracheostomy severe coagulopathy severe respiration difficulties intubation/extubation/tube exchange difficulties

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Tracheostomy<br>Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 3 days from intubation. | Procedure: Early Tracheostomy<br>* Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.<br>|
| Active Comparator: Prolonged Intubation<br>Patients randomized to this arm will be tried to wean off the ventilator and get (an) extubation trial(s) if regarded feasible. In case of failure or non-feasibility, they receive tracheostomy between days 7 to 14 from intubation. | Procedure: Late Tracheostomy<br>* Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Care Unit Length of Stay (ICU-LOS) | The primary endpoint is assessed as days from admission to until discharge from the intensive care unit. | open | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of ICU-dependence | This secondary endpoint is assessed as days from admission to a pre-defined status that would allow discharge from ICU (absence of active infection, vasopressors, pulmonary and cardial instability etc.) | open | 
| Functional Outcome | This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints. | admission, discharge, at 6 months | 
| Mortality | This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission. | during stay, after 6 months | 
| Hospital Length of Stay | This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge. | open | 
| Duration of Ventilation | This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h. | open | 
| Duration and Quality of Weaning | This secondary endpoint is assessed as half-days spent under the possible application of a weaning protocol, and spent within specific phases of such a protocol. | Within ventilation time | 
| Time of Analgosedation Dependence | This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified. | within ICU-LOS | 
| Vasopressor Dependence | This secondary endpoint is assessed as half-days spent under vasopressors. | within ICU-LOS | 
| Time of Antibiotic Treatment | This secondary endpoint is assessed as half-days under antibiotic treatment | within ICU-LOS | 
| Pneumonias | This secondary endpoint is assessed as episodes (pre-defined by diagnostic criteria) of pneumonia. | within ICU-LOS | 
| Occurrence and Duration of Sepsis | This secondary endpoint is assessed as the number of episodes and duration of sepsis as pre-defined by diagnostic criteria. | within ICU-LOS | 
| Number and type of complications associated with the procedure | This secondary endpoint is assessed as the number and types of complications arelated to tracheostomy (i.e. bleeding, mispositioning, malfunction, replacement demand,etc.). | 10 days post tracheostomy | 
| Cost of Treatment | This secondary endpoint is assessed as the total ICU-costs etsimated by length of stay and severety-derived DRG-multiplicator of each individual patient. | within ICU-LOS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurocritical Care, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Tracheostomy, Tracheotomy, Percutaneous Dilatative Tracheostomy, Weaning, Ventilation