Awake Tracheal Intubation in Critical Care Patients

Completed

• Conditions: Videolaryngoscopy; Intensive Care Unit Syndrome
• Interventions: Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)

• Registration Number: NCT05802316
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

Tracheal intubation in critical care is a high-risk procedure requiring significant expertise and airway strategy modifications, such as awake intubation with video laryngoscope or flexible endoscope intubation. Furthermore, delayed sequence intubation can be used by experts in certain high-risk subgroups. The investigators hypothesise that awake tracheal intubation is associated with a lower incidence of severe adverse events than standard tracheal intubation in critical care patients.

Detailed Description

Intubation records from 2020 to 2022 were acquired to examine all tracheal intubations of critical care patients at a tertiary hospital. Each awake tracheal intubation (awake) case - all of which were performed using a videolaryngoscope with a hyperangulated blade - was propensity matched with two controls (1:2 ratio; standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) undergoing general anaesthesia), with similar comorbidities and intubations performed after the induction of anaesthesia (asleep).

Study Timeline

• Study Start: 2020-01-03
• Primary Completion: 2022-04-30
• Study Completion: 2022-11-03
• Study First Submitted: 2023-03-22
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Data for all critical care patients requiring tracheal intubation during the study period

Exclusion Criteria

• included incomplete data reports

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
awake	tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)	awake tracheal intubation
asleep	tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)	standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)

Primary Outcome Measures

Name	Time	Method
desaturation	during intubation procedure (within 30 Minutes)	defined as SpO2 \< 80% after sufficient preoxygenation
Hypotension	during intubation procedure (within 30 Minutes)	defined as a mean arterial pressure \< 55 mmHg
cardiac arrest	during intubation procedure (within 30 Minutes)	defined as a peri-interventional cardiac arrest

Secondary Outcome Measures

Name	Time	Method
Airway Injury	during intubation procedure (< 120 seconds)	dental injury
other adverse events	during intubation procedure (< 120 seconds)	soft tissue injury
Cormack and Lehane classification (Class I-IV)	during intubation procedure (< 120 seconds)	glottis visualisation
FPS	during intubation procedure (< 120 seconds)	First Pass Intubation success

Trial Locations

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany