A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation

Last updated: January 9, 2025
Sponsor: American University of Beirut Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

A double-operator technique for GlideScope intubation

A single-operator technique for GlideScope intubation.

Clinical Study ID

NCT06727513
BIO-2024-0231
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 generalanesthesia

Exclusion

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 refluxdisease (GERD), hiatal hernia, full stomach)

  • Patients with an oropharyngeal/laryngeal pathology (tumor, abscess)

  • Patients with maxillary or mandibular fracture

Study Design

Total Participants: 428
Treatment Group(s): 2
Primary Treatment: A double-operator technique for GlideScope intubation
Phase:
Study Start date:
January 09, 2025
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • American University of Beirut Medical Center

    Beirut,
    Lebanon

    Active - Recruiting

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