Awake Tracheal Intubation in Critical Care Patients

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Completed

CT.gov ID

NCT05802316

Collaborator

(none)

140

Enrollment

Location

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Videolaryngoscopy Intensive Care Unit Syndrome	Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)

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 Design

Study Type:

Observational

Actual Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 3, 2020

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Nov 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
awake awake tracheal intubation	Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) In the awake group tracheal intubation performed by an videolaryngoscope with a hyperangulated blade. In the asleep group the standard intubation were performed by videolaryngoscopy (VL) and direct laryngoscopy (DL)
asleep standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)	Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) In the awake group tracheal intubation performed by an videolaryngoscope with a hyperangulated blade. In the asleep group the standard intubation were performed by videolaryngoscopy (VL) and direct laryngoscopy (DL)

Arm

Intervention/Treatment

awake

awake tracheal intubation

Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)

In the awake group tracheal intubation performed by an videolaryngoscope with a hyperangulated blade. In the asleep group the standard intubation were performed by videolaryngoscopy (VL) and direct laryngoscopy (DL)

asleep

standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)

Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)

Outcome Measures

Primary Outcome Measures

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
desaturation [during intubation procedure (within 30 Minutes)]
defined as SpO2 < 80% after sufficient preoxygenation

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

included incomplete data reports

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate	Germany	D55131

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Investigators

Principal Investigator: Marc Kriege, University Medical Centre Mainz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marc Kriege, MD, Principal Investigator, Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT05802316

Other Study ID Numbers:

JohannesGUK

First Posted:

Apr 6, 2023

Last Update Posted:

Apr 6, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 6, 2023