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Completed

NCT Number: NCT05802316

Awake Tracheal Intubation in Critical Care Patients

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.

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Key information

Conditions

Videolaryngoscopy Intensive Care Unit Syndrome

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • included incomplete data reports

Treatment and study plan

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)

Primary outcomes

  1. Hypotension

    Time frame: during intubation procedure (within 30 Minutes)

    defined as a mean arterial pressure < 55 mmHg

  2. cardiac arrest

    Time frame: during intubation procedure (within 30 Minutes)

    defined as a peri-interventional cardiac arrest

  3. desaturation

    Time frame: during intubation procedure (within 30 Minutes)

    defined as SpO2 < 80% after sufficient preoxygenation

Secondary outcomes

  1. Cormack and Lehane classification (Class I-IV)

    Time frame: during intubation procedure (< 120 seconds)

    glottis visualisation

  2. FPS

    Time frame: during intubation procedure (< 120 seconds)

    First Pass Intubation success

  3. Airway Injury

    Time frame: during intubation procedure (< 120 seconds)

    dental injury

  4. other adverse events

    Time frame: during intubation procedure (< 120 seconds)

    soft tissue injury

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: Awake

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2023
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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