Intubation; Difficult or FailedNCT06727513
A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation
A study testing A single-operator technique for GlideScope intubation. and A double-operator technique for GlideScope intubation in people with Intubation; Difficult or Failed and Intubation Complication, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication, Airway Trauma
- What is being tested?
- A single-operator technique for GlideScope intubation. and A double-operator technique for GlideScope intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jan 2025to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- A single-operator technique for GlideScope intubation., A double-operator technique for GlideScope intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single-operator technique for GlideScope intubation.Procedure or surgery
A single-operator technique where the senior resident will insert the GlideScope and perform the endotracheal intubation using an angulated stylet.
A double-operator technique for GlideScope intubationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | A single-operator technique for GlideScope intubation. Receives: Procedure: A single-operator technique for GlideScope intubation. |
| Experimental | Experimental | A double-operator technique for GlideScope intubation Receives: Procedure: A double-operator technique for GlideScope intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate of endotracheal intubation
First attempt success rate of endotracheal intubation measured by Yes/No
Measured: Recorded during the procedure
Secondary outcomes (5)
Time to intubate
Time to intubate measured in seconds
Measured: Recorded during the procedure
The need for optimization maneuvers
The need for optimization maneuvers measured by Yes/No
Measured: 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
Measured: Recorded during the procedure
The incidence of airway trauma
The incidence of airway trauma measured by Yes/No
Measured: 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
Measured: Post-operative sore throat measured one hour after transfer to post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jan 2025
- Primary completion29 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Kaddoum, American University of Beirut Medical Center
- Investigators
- Roland Kaddoum, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727513
- Sponsor's protocol ID
- BIO-2024-0231
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Operator Technique for GlideScope-Assisted Endotracheal Intubation: Does It Yield a Similar Success Rate? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06727513
- Acronym / sponsor ID
- BIO-2024-0231
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 29 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: A single-operator technique for GlideScope intubation.A single-operator technique for GlideScope intubation. |
| Experimental | Experimental | Procedure: A double-operator technique for GlideScope intubationA double-operator technique for GlideScope intubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Control |
| A double-operator technique for GlideScope intubationA 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. | Procedure or surgery | Experimental |
Primary outcome
First attempt success rate of endotracheal intubation
Time frame: Recorded during the procedure
First attempt success rate of endotracheal intubation measured by Yes/No
5 secondary outcomes
Time to intubate
Time frame: Recorded during the procedure
The need for optimization maneuvers
Time frame: Recorded during the procedure
Occurrence of adverse events during intubation
Time frame: Recorded during the procedure
The incidence of airway trauma
Time frame: Recorded during the procedure
Incidence and severity of post-operative sore throat
Time frame: Post-operative sore throat measured one hour after transfer to post anesthesia care unit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Kaddoum, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A single-operator technique for GlideScope intubation. and A double-operator technique for GlideScope intubation in people with Intubation; Difficult or Failed and Intubation Complication, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success rate of endotracheal intubation (time frame: Recorded during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.