Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation

Sponsor

Ain Shams University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05751590

Collaborator

(none)

Enrollment

Location

Arms

6.2

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: comined use of gliddescope and fiberoptic broncscopy Device: fiberoptic bronscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Combined Use of Glidescope With Fiber Optic Broncscopy Versus Fiber Optic Alone in Difficult Intubation: a Randomized Clinical Trial

Anticipated Study Start Date :

Mar 10, 2023

Anticipated Primary Completion Date :

Sep 10, 2023

Anticipated Study Completion Date :

Sep 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glidescope + Fiberoptic broncscopy	Device: comined use of gliddescope and fiberoptic broncscopy endotrachotreal intubation will be done by combined use of Glidescope and Fiberoptic broncscopy
Active Comparator: Fiberoptic broncscopy	Device: fiberoptic bronscopy endotrachotreal intubation will be done by Fiberoptic broncscopy

Arm

Intervention/Treatment

Active Comparator: Glidescope + Fiberoptic broncscopy

Device: comined use of gliddescope and fiberoptic broncscopy

endotrachotreal intubation will be done by combined use of Glidescope and Fiberoptic broncscopy

Active Comparator: Fiberoptic broncscopy

Device: fiberoptic bronscopy

endotrachotreal intubation will be done by Fiberoptic broncscopy

Outcome Measures

Primary Outcome Measures

Endotracheal intubation [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05751590

Other Study ID Numbers:

FMASU R08/2023

First Posted:

Mar 2, 2023

Last Update Posted:

Mar 2, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 2, 2023