Trials / Recruiting
RecruitingNCT06727513
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 428 (estimated)
- Sponsor
- American University of Beirut Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2025-01-01
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2024-12-11
- Last updated
- 2026-02-06
Locations
1 site across 1 country: Lebanon
Source: ClinicalTrials.gov record NCT06727513. Inclusion in this directory is not an endorsement.