Awake Tracheal Intubation in Critical Care Patients (Awake)

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

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.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Syndrome; Videolaryngoscopy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, D55131
      • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

critical care patients requiring tracheal intubation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• included incomplete data reports

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Marc Kriege, University Medical Centre Mainz

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JohannesGUK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No