Comparison of combined and general anesthesia for percutaneous dilation tracheostomy in patients with severe acute brain injury

Phase 4

• Conditions: AnesthesiaPercutaneous Dilation Tracheostomy; S06; I61; I60; Intracranial injury; Intracerebral haemorrhage; Subarachnoid haemorrhage

• Registration Number: DRKS00011243
• Lead Sponsor: Elizavetinskaya bolnitsa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-02
• Study Completion: 2019-02-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

intracranial injury, intracerebral hemorrhage, subarachnoid hemorrhage, severe acute brain injury (Glasgow Coma Scale on admission 3-8)

Exclusion Criteria

patients with bilateral fixed and dilated pupils, infusion of vasopressors or inotropic drugs at the moment of including, short cricosternal distance (less than 2,5 cm), coagulopathy (INR>1,5; APTT>55s; Fibrinogen<1,5g/l; platelets count < 100 pl/mkl ),chronic cardiovascular diseases (coronary artery disease, history of myocardial infarction, congestive heart failure, atrial fibrillation, a history (more than 1 month) of antihypertensive and antiarrhythmic drugs intake)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stress-response [time frame: from endotracheal tube positioning till tracheostomy tube is inserted] combined end-point: mean-arterial blood pressure or heart rate rise more than 20% from baseline (mean-arterial blood pressure and heart rate after anesthesia induction but before endotracheal tube positioning)

Secondary Outcome Measures

Name	Time	Method
- arterial blood pressure rise [time frame: from endotracheal tube positioning till tracheostomy tube is inserted] arterial blood pressure (measured non-invasively with 2 minutes interval) rise proportion <br>- heart rate rise [time frame: from endotracheal tube positioning till tracheostomy tube is inserted] heart rate (measured continuously) rise proportion<br>- arterial blood pressure fall[time frame: from anesthesia induction till the start of an endotracheal tube positioning] arterial blood pressure (measured non-invasively with 2 minutes interval) rise proportion<br>- anesthesia time [time frame: from thiopental bolus or speed rise till tracheostomy tube is inserted] anesthesia time measured in seconds within time frame<br>- lidocain systemic toxicity [time frame: from lidocain injection till tracheostomy tube is inserted] lidocain systemic toxicity signes including abrupt blood pressure fall, arrhythmia (bradycardia, extrasystolia), seizures <br>