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Awake Tracheal Intubation in Critical Care Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05802316
Acronym
Awake
Enrollment
140
Registered
2023-04-06
Start date
2020-01-03
Completion date
2022-11-03
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome, Videolaryngoscopy

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).

Interventions

DEVICEtracheal 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)

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* included incomplete data reports

Design outcomes

Primary

MeasureTime frameDescription
Hypotensionduring intubation procedure (within 30 Minutes)defined as a mean arterial pressure \< 55 mmHg
cardiac arrestduring intubation procedure (within 30 Minutes)defined as a peri-interventional cardiac arrest
desaturationduring intubation procedure (within 30 Minutes)defined as SpO2 \< 80% after sufficient preoxygenation

Secondary

MeasureTime frameDescription
Cormack and Lehane classification (Class I-IV)during intubation procedure (< 120 seconds)glottis visualisation
FPSduring intubation procedure (< 120 seconds)First Pass Intubation success
Airway Injuryduring intubation procedure (< 120 seconds)dental injury
other adverse eventsduring intubation procedure (< 120 seconds)soft tissue injury

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026