- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158088
Video Laryngoscope Versus USB Borescope in Difficult Intubation
Video Laryngoscope Versus a USB Borescope Aided Endotracheal Intubation in Adults With Anticipated Difficult Airway
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For patients allocated to the USB-borescope technique, a proper size endotracheal tube will be placed over the USB-borescope (with an external diameter of 5.5 mm) which will be coated externally with water-soluble lubricant. The proper size laryngoscope blade will be inserted. The USB-borescope will be placed through the oral cavity and will be advanced while tracking it on a mobile phone, it will be advanced to the glottic opening. If needed, rotation of USB-borescope and/or external laryngeal manipulation will be used to align it with the vocal cord.
For patients allocated to the intubation over Video Laryngoscope technique, video laryngoscope (Insighters insight is3) proper size blade will be placed and introduction of the Video Laryngoscope till viewing the glottis opening then insertion of a proper sized endotracheal tube
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 11562
- Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1.American Society of Anesthesiologist ASA physical status I-II patients. 2.Both genders. 3.Age18-60 years old 4.BMI <35 5.patients with El-Ganzouri score more than or equal to 4
Exclusion Criteria:
- Presence of pulmonary diseases
- Uncontrolled hypertension
- Ischemic heart disease
- Cervical spine fracture
- Limited mouth opening
- known to have tumors or polyps in the upper airway
- History of difficult intubation or difficult bag-mask ventilation
- Patients with difficult bag-mask ventilation after induction of anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Borescope group
Using an Endotracheal tube mounted over Borescope with the aid of conventional laryngoscope for intubation
|
Endotracheal intubation using borescope
|
ACTIVE_COMPARATOR: Videolaryngoscope group
Using videolaryngoscope for intubation
|
Endotracheal intubation using video laryngoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of intubation
Time Frame: 5 minutes
|
in seconds
|
5 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure before intubation, every 5 minutes after intubation till 15 minutes after intubation
Time Frame: 15 minutes
|
Systolic, diastolic, and mean arterial blood pressures
|
15 minutes
|
Heart rate Heart rate
Time Frame: 15 minutes
|
Heart rate before intubation, every 5 minutes after intubation till 15 minutes after intubation
|
15 minutes
|
The degree of view clarity
Time Frame: 1 minute
|
Cormack-Lehane grading
|
1 minute
|
Incidence of complications
Time Frame: 48 hours
|
Incidence of complications as bleeding, failure
|
48 hours
|
Number of trials for correct endotracheal intubation
Time Frame: 2 minutes
|
Number of trial till successful intubation
|
2 minutes
|
Collaborators and Investigators
Sponsor
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
Keywords
Other Study ID Numbers
- N-15-2021/MSc
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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