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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05802316
Other study ID # JohannesGUK
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2020
Est. completion date November 3, 2022

Study information

Verified date April 2023
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date November 3, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Data for all critical care patients requiring tracheal intubation during the study period Exclusion Criteria: - included incomplete data reports

Study Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Germany Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University Mainz Rhineland-Palatinate

Sponsors (1)

Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypotension defined as a mean arterial pressure < 55 mmHg during intubation procedure (within 30 Minutes)
Primary cardiac arrest defined as a peri-interventional cardiac arrest during intubation procedure (within 30 Minutes)
Primary desaturation defined as SpO2 < 80% after sufficient preoxygenation during intubation procedure (within 30 Minutes)
Secondary Cormack and Lehane classification (Class I-IV) glottis visualisation during intubation procedure (< 120 seconds)
Secondary FPS First Pass Intubation success during intubation procedure (< 120 seconds)
Secondary Airway Injury dental injury during intubation procedure (< 120 seconds)
Secondary other adverse events soft tissue injury during intubation procedure (< 120 seconds)
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