- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05851664
Do we Intubate Faster With the Videolaryngoscope?
The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.
This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intubation on full stomach is at high risk of pulmonary suction. It must be quick, as this risk increases with the time needed to intubate. Videolaryngoscope (VL) is recommended in case of difficult airway. Yet, its interest in full stomach remains unclear, as the time needed to intubate with a VL is variable in literature. The Aim of the study was to determine the impact of the videolaryngoscpe on the time needed to intubate.
This was a Prospective, randomized, simple blinded study. The participants intubated patients for surgery under general anesthesia either with direct laryngoscpy or with videolaryngoscopy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tunis, Tunisia, 2085
- Mongi Slim hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age > 18 years-old;
- ASA status 1 to 3;
- General anesthesia and intubation.
Exclusion Criteria:
- Difficult intubations criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group Direct laryngoscopy (DL)
Group DL: intubated with direct laryngoscopy type Macintosh.
|
intubation using a direct laryngoscopy type macintosh
Other Names:
|
Experimental: Group vidéo Laryngoscopy (VL)
Group VL: intubated with a video laryngoscope type McGrath
|
Intubation using a videolaryngoscope type McGrath
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time needed to intubate
Time Frame: during the intubation
|
Time needed to the operator to pass the tube through vocal cords in seconds
|
during the intubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of intubation attempts.
Time Frame: at the end of intubation
|
number of attempts needed to intubate
|
at the end of intubation
|
Major desaturation
Time Frame: during intubation
|
an oximetry under 90 %
|
during intubation
|
Difficulty of the laryngoscopy
Time Frame: at the end of intubation
|
cormack anf lehane grade (1 to 4) 1 and 2 indicate easy laryngoscopy and 3 and 4 indicate difficult laryngoscopy
|
at the end of intubation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mhamed Sami MS Mebazaa, Pr, Mongi Slim hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Time to intubate VL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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