A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation

A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation: Does It Yield a Similar Success Rate? A Randomized Controlled Trial

The primary objective of this study is to compare the first attempt success rate of endotracheal intubation using the GlideScope video laryngoscope when performed by two operators versus a single operator.

Secondary objectives include assessing the time to intubate, the need for optimization maneuvers, the effect of the presence of predictors of difficult intubation, the occurrence of adverse events during intubation such as oxyhemoglobin desaturation to less than 90% measured by pulse oximetry, the incidence of airway trauma, and the incidence and severity of post-op sore throat. The main question it aims to answer is: Is endotracheal intubation performed using the Glidescope video laryngoscope with an intubating stylet by two operators, non-inferior to the same procedure performed by single operator in terms of first attempt success rate? Researchers will compare first attempt success rate of endotracheal intubation using the GlideScope video laryngoscope when performed by two operators versus a single operator to see if assistance in using the GlideScope provides similar first attempt success rate of endotracheal intubation and thus guarantees securing a difficult airway.

Participants will be enrolled in one of two groups over 9 months of work. They will be further stratified into blocks according to the presence of at least one predictor of difficult intubation. Patients allocated to the control group will be intubated using the GlideScope by a single operator and those allocated to the experimental group will be intubated using the GlideScope with the assistance of a second operator.

Study Overview

• Status: Completed
• Conditions: Intubation Complication; Intubation; Difficult or Failed; Airway Trauma
• Intervention / Treatment: Procedure: A single-operator technique for GlideScope intubation.; Procedure: A double-operator technique for GlideScope intubation

Detailed Description

GlideScope-assisted flexible fiberoptic intubation has been successfully used in cases of anticipated and unexpected difficult airways. This technique depends on two operators where the second operator assists in holding the GlideScope while intubation is being attempted by the first operator. However, it is not yet established whether this two-operator technique has any effect on the success rate of first-attempt intubation by the GlideScope video laryngoscope. The primary objective of this study is to compare the first attempt success rate of endotracheal intubation using the GlideScope video laryngoscope when performed by two operators versus a single operator.

Secondary objectives include assessing the time to intubate, the need for optimization maneuvers, the effect of the presence of predictors of difficult intubation, the occurrence of adverse events during intubation such as oxyhemoglobin desaturation to less than 90% measured by pulse oximetry, the incidence of airway trauma, and the incidence and severity of post-operative sore throat. In this prospective randomized controlled trial, 428 patients (214 in each group) adult patients will be enrolled in one of two groups over 9 months of work. They will be further stratified into blocks according to the presence of at least one predictor of difficult intubation. Patients allocated to the control group will be intubated using the GlideScope by a single operator (the resident on the study). Those allocated to the experimental group will be intubated using the GlideScope with the assistance of a second operator (the resident and the attending physician). In both groups, the time to intubate will be measured by the attendings on the study, along with other parameters collected by the resident on the study. If intubation fails, the airway will be subsequently managed using any technique deemed appropriate by the attending anesthesiologist. Data comparing the success rate of endotracheal intubation when a second operator assists in holding the GlideScope is missing. This two-operator technique is essential in the new multimodal airway management involving video-assisted flexible fiberoptic intubation. Our study will determine whether the assistance in using the GlideScope provides similar first attempt success rate of endotracheal intubation and thus guarantees securing a difficult airway.

• Study Type: Interventional
• Enrollment (Actual): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult population ≥ 18 years of age
• American Society of Anesthesiologists (ASA) Class I to III
• Elective procedures
• Patients requiring orotracheal intubation with a single-lumen tube under general anesthesia

Exclusion Criteria:

• American Society of Anesthesiologists (ASA) IV or V
• Emergency procedures
• Patients who require awake or asleep fiberoptic intubation
• Patients who require nasal intubation
• Patients who require double-lumen endotracheal tube (ETT)
• Patients who are already intubated
• Patients who require rapid sequence induction (uncontrolled Gastroesophageal reflux disease (GERD), hiatal hernia, full stomach)
• Patients with an oropharyngeal/laryngeal pathology (tumor, abscess)
• Patients with maxillary or mandibular fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; A single-operator technique for GlideScope intubation.	Procedure: A single-operator technique for GlideScope intubation.; A single-operator technique where the senior resident will insert the GlideScope and perform the endotracheal intubation using an angulated stylet.
Experimental: Experimental; A double-operator technique for GlideScope intubation	Procedure: A double-operator technique for GlideScope intubation; A double-operator technique where the senior resident will insert the GlideScope until visualizing an optimal glottic view, then the attending physician will take over the GlideScope keeping it in the same fixed position, while the resident performs the endotracheal intubation using an angulated stylet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate of endotracheal intubation	First attempt success rate of endotracheal intubation measured by Yes/No	Recorded during the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubate	Time to intubate measured in seconds	Recorded during the procedure
The need for optimization maneuvers	The need for optimization maneuvers measured by Yes/No	Recorded during the procedure
Occurrence of adverse events during intubation	Occurrence of adverse events during intubation such as oxyhemoglobin desaturation to less than 90% measured by pulse oximetry	Recorded during the procedure
The incidence of airway trauma	The incidence of airway trauma measured by Yes/No	Recorded during the procedure
Incidence and severity of post-operative sore throat	Incidence and severity of post-operative sore throat measured by Yes/No and low pain/high pain	Post-operative sore throat measured one hour after transfer to post anesthesia care unit

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Roland Kaddoum, MD, American University of Beirut Medical center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): May 29, 2026
• Study Completion (Actual): May 29, 2026

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2024-0231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No