- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751590
Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation
Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation: a Randomized Clinical Trial
In spite of the development of a lot of airway devices in the past 2 decades, tracheal intubation problems were the most common primary airway problems.
The GlideScope® Video Laryngoscope (Verathon, Bothell, WA) is a video laryngoscopy system with a two-segment blade, the distal portion of which houses a charge-coupled device that contains a micro-video camera that transmits images to a 7-inch video liquid crystal display (LCD) monitor. The GlideScope® can be used for routine intubation but is also commonly used as an alternative device for difficult or failed airways. It is particularly useful in cases where cervical motion or mouth opening is limited, preventing creation of a "straight line" of sight from the operator to the glottis .
GlideScope improves the laryngeal view as one of its advantages due to the blade angle of 60° which is designed to improve the glottic view without the need of alignment of the oral, pharyngeal, and tracheal axes and also without adding additional lifting force.
Fibreoptic intubation with a flexible bronchoscope is an important airway management skill in which anaesthesiologists should be proficient. Unfortunately, clinical experience shows that even with reasonable experience and practice, fibreoptic intubation can be challenging. It requires a high degree of manual dexterity, an ability to manoeuvre quickly under stressful clinical situations, and rigorous training and practice to maintain a high level of skill.
Thus, whereas fibreoptic intubatThus, whereas fibreoptic intubation can be used rapidly for intubation, video laryngoscopy may be an effective alternative, especially in patients with an anticipated difficult airway. However, it remains unclear whether video-assisted airway management using the GlideScope provides significant advantages over flexible bronchoscopy in patients with potentially difficult airways , Video laryngoscopy is increasingly used for difficult airway management in anaesthesia, intensive care units and emergency departments. Recently, video laryngoscopy has been incorporated into various difficult airway management algorithms, being recommended as one of the initial steps in the management of difficult airways .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Ain shams university hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients who will be scheduled for elective surgery requiring orotracheal or nasotracheal intubation with anticipated difficult intubation.
- physical status American Society of Anesthesiologists (ASA) I - III.
Exclusion Criteria:
- Patients who refuse to participate
- patients with body mass index (BMI) >35 kg/m2
- coagulopathy, severe thrombocytopenia <50×103.
- Pregnant females
- physical status American Society of Anesthesiologists (ASA)>IV
- patients requiring rapid sequence induction
- patients with closed mouth opening who are candidates only for nasal intubation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Glidescope + Fiberoptic broncscopy
|
endotrachotreal intubation will be done by combined use of Glidescope and Fiberoptic broncscopy
|
|
Active Comparator: Fiberoptic broncscopy
|
endotrachotreal intubation will be done by Fiberoptic broncscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endotracheal intubation
Time Frame: 1st seconds till succesfull intubation
|
Intubation time is defined as the time from insertion of either the GlideScope combined with the Fiberoptic broncscopy or the Fiberoptic broncscopy alone into the mouth, to the time when end tidal CO2 exceeded (20 mmHg)
|
1st seconds till succesfull intubation
|
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
Other Study ID Numbers
- FMASU R08/2023
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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