Awake Tracheal Intubation in Critical Care Patients

Intensive Care Unit Syndrome Clinical Trial

— Awake  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802316
• Other study ID #: JohannesGUK
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome
• Videolaryngoscopy

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)