Awake Tracheal Intubation in Critical Care Patients

NCT05802316 | Completed

• 1 other identifier: JohannesGUK
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Videolaryngoscopy; Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (3)

• Hypotension

  defined as a mean arterial pressure \< 55 mmHg

  during intubation procedure (within 30 Minutes)

• cardiac arrest

  defined as a peri-interventional cardiac arrest

  during intubation procedure (within 30 Minutes)

• desaturation

  defined as SpO2 \< 80% after sufficient preoxygenation

  during intubation procedure (within 30 Minutes)

Secondary Outcomes (4)

• Cormack and Lehane classification (Class I-IV)

  during intubation procedure (< 120 seconds)

• FPS

  during intubation procedure (< 120 seconds)

• Airway Injury

  during intubation procedure (< 120 seconds)

• other adverse events

  during intubation procedure (< 120 seconds)

Study Arms (2)

awake

awake tracheal intubation

Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation 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)

Interventions

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

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; awake

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

critical care patients requiring tracheal intubation

You may qualify if:

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

You may not qualify if:

• included incomplete data reports

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Study Officials

• Marc Kriege

  University Medical Centre Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 6, 2023
• Study Start: January 3, 2020
• Primary Completion: April 30, 2022
• Study Completion: November 3, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

DE (1)