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Clinical Trials/NCT05802316
NCT05802316
Completed
Not Applicable

Awake Tracheal Intubation is Associated With Fewer Adverse Events in Critical Care Patients Than Standard Tracheal Intubation

Johannes Gutenberg University Mainz1 site in 1 country140 target enrollmentJanuary 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Videolaryngoscopy
Sponsor
Johannes Gutenberg University Mainz
Enrollment
140
Locations
1
Primary Endpoint
desaturation
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 3, 2020
End Date
November 3, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Marc Kriege, MD

Principal Investigator

Johannes Gutenberg University Mainz

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • included incomplete data reports

Outcomes

Primary Outcomes

desaturation

Time Frame: during intubation procedure (within 30 Minutes)

defined as SpO2 \< 80% after sufficient preoxygenation

Hypotension

Time Frame: during intubation procedure (within 30 Minutes)

defined as a mean arterial pressure \< 55 mmHg

cardiac arrest

Time Frame: during intubation procedure (within 30 Minutes)

defined as a peri-interventional cardiac arrest

Secondary Outcomes

  • Airway Injury(during intubation procedure (< 120 seconds))
  • other adverse events(during intubation procedure (< 120 seconds))
  • Cormack and Lehane classification (Class I-IV)(during intubation procedure (< 120 seconds))
  • FPS(during intubation procedure (< 120 seconds))

Study Sites (1)

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