A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation

NCT06727513 | Recruiting

• 1 other identifier: BIO-2024-0231
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Difficult or Failed; Intubation Complication; Airway Trauma

Outcome Measures

Primary Outcomes (1)

• First attempt success rate of endotracheal intubation

  First attempt success rate of endotracheal intubation measured by Yes/No

  Recorded during the procedure

Secondary Outcomes (5)

• Time to intubate

  Recorded during the procedure

• The need for optimization maneuvers

  Recorded during the procedure

• Occurrence of adverse events during intubation

  Recorded during the procedure

• The incidence of airway trauma

  Recorded during the procedure

• Incidence and severity of post-operative sore throat

  Post-operative sore throat measured one hour after transfer to post anesthesia care unit

Study Arms (2)

Control

ACTIVE COMPARATOR

A single-operator technique for GlideScope intubation.

Procedure: A single-operator technique for GlideScope intubation.

Experimental

EXPERIMENTAL

A double-operator technique for GlideScope intubation

Procedure: A double-operator technique for GlideScope intubation

Interventions

A single-operator technique for GlideScope intubation. PROCEDURE

A single-operator technique where the senior resident will insert the GlideScope and perform the endotracheal intubation using an angulated stylet.

Control

A double-operator technique for GlideScope intubation PROCEDURE

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Study Officials

• Roland Kaddoum, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland Kaddoum, MD

CONTACT

01350000; rk16@aub.edu.lb

Thuraya HajAli, MSc

CONTACT

th64@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)