Intubation; Difficult or FailedNCT05843565
Standard Versus Hyperangulated Video Laryngoscopy Blades for Intubation in Neonates and Small Infants
A study testing Non-standard blade (NSB) and Standard blade (SB) in people with Intubation; Difficult or Failed, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The goal of this prospective randomized cross over clinical trial is to compare the difference in the percentage of glottic opening (POGO) between two different video laryngoscopy blades, the hyperangulated Cobalt blade and the straight Miller blade in neonates or small infants with body weight ≤ 5 kg and age ≤ 3… Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Non-standard blade (NSB) and Standard blade (SB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteLebanon
- Study dates
- 14 Jun 2023to 29 Oct 2025
- 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 Up to 3 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months, scheduled for elective surgery under general anesthesia.
- ASA (American Society of Anesthesiologists) class I-III patients.
Who cannot join
- Patients with a history of difficult airway or with craniofacial and airway anomalies.
- ASA (American Society of Anesthesiologists) class IV patients.
- Recent respiratory tract infection within the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Versus Hyperangulated Video Laryngoscopy Blades for Intubation in Neonates and Small Infants: Evaluation of the Glottic View
The goal of this prospective randomized cross over clinical trial is to compare the difference in the percentage of glottic opening (POGO) between two different video laryngoscopy blades, the hyperangulated Cobalt blade and the straight Miller blade in neonates or small infants with body weight ≤ 5 kg and age ≤ 3 months.
The main questions it aims to answer are:
Read more
- Is there a significant difference in the POGO using the standard Miller video laryngoscope blade versus the non-standard hyperangulated Cobalt video laryngoscope blade in neonates and small infants?
- Are there significant differences in the first attempt success rate at intubation, the number of attempts, the time to successful intubation, the type of blade used for successful intubation, and the occurrence of adverse events during intubation, such as episodes of bradycardia or desaturation? 40 (20 in each group) neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months will be enrolled in one of the two groups over 2 years of work.
Researchers will compare the POGO and Cormack and Lehane (C\&L) classification using the hyperangulated Cobalt blade versus the straight Miller blade to identify the technique that provides optimal glottic views and intubating conditions in this patient population, and thus improved patient's safety.
Read the detailed description
A higher incidence of difficult airway has been reported in neonates and infants than in adults. Optimizing glottic view during tracheal intubation is very challenging in neonates and small infants and it is not clear whether the design of the intubating blade using video laryngoscopy has a major influence of the glottic view and subsequently on the success of intubation.
The primary objective of this study is to compare the difference in the percentage of glottic opening (POGO) between two different video laryngoscopy blades, the hyperangulated Cobalt blade and the straight Miller blade. The secondary objectives are the first attempt success rate at intubation, the number of attempts, the time to successful intubation, and the occurrence of adverse events during intubation, such as desaturation or bradycardia.
In this prospective randomized cross over clinical trial, 40 (20 in each group) neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months will be enrolled in one of two groups over 1 year of work. In patients allocated to the Cobalt group, the POGO and Cormack and Lehane (C\&L) classification will be recorded using video laryngoscopy with a Cobalt blade followed by an assessment using the Miller blade. In patients allocated to the Miller group, the POGO and C\&L classification will be recorded using video laryngoscopy with a Miller blade followed by an assessment using the Cobalt blade. In both groups, intubation will be attempted during the second assessment. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist.
Data comparing straight and hyperangulated video laryngoscopy blades in neonates and small infants are limited. Both techniques are standard of care at our institution. This study will identify the technique that provides optimal glottic views and intubating conditions in this patient population, and thus improved patient's safety.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Non-standard blade (NSB), Standard blade (SB)
- Keywords
- Intubation, Laryngoscopy, Pediatrics, Neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-standard blade (NSB)Device
GlideScope® VL (Verathon Inc, WA, USA) hyperangulated blade 2
Standard blade (SB)Device
standard Miller blade 0 or 1
| Study group | Role | What they receive |
|---|---|---|
| Sequence of NSB first | Experimental | In patients allocated to the sequence of NSB first, the POGO and C\&L classification will be recorded using video laryngoscopy with the hyperangulated blade 2 followed by an assessment using the Miller blade 0 or 1. Intubation will then be attempted during the second assessment. Endotracheal tube size will be selected according to body weight and a guiding stylet will be used. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist. Receives: Device: Non-standard blade (NSB); Device: Standard blade (SB) |
| Sequence of SB first | Placebo comparator | In patients allocated to the Miller group, the POGO and C\&L classification will be recorded using video laryngoscopy with a Miller blade 0 or 1 followed by an assessment using the Cobalt blade 2. Intubation will then be attempted during the second assessment. Endotracheal tube size will be selected according to body weight and a guiding stylet will be used. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist. Receives: Device: Non-standard blade (NSB); Device: Standard blade (SB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
POGO %
Percentage of Glottic Opening
Measured: Intraoperatively
C&L classification
Cormack and Lehane classification for glottic view.
Measured: Intraoperatively
Secondary outcomes (3)
Intubation attempts
Number of intubation attempts.
Measured: Intraoperatively
Time to successful tracheal intubation
Anesthesia timeline (seconds) from first intubation attempt to first EtCO2 detection
Measured: Intraoperatively
Adverse events during intubation
Occurrence of events such as: Desaturation (SpO2 < 95%) and bradycardia.
Measured: Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start14 Jun 2023
- Primary completion29 Oct 2025
- Study completion29 Oct 2025
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marie Awad, American University of Beirut Medical Center
- Investigators
- Marie Aouad-Maroun, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843565
- Sponsor's protocol ID
- BIO-2022-0348
- Status last verified
- Dec 2025
- First submitted
- 25 Apr 2023
- Last updated
- 2 Jan 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 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Hyperangulated Video Laryngoscopy Blades for Intubation in Neonates and Small Infants: Evaluation of the Glottic View
- ClinicalTrials.gov ID
- NCT05843565
- Acronym / sponsor ID
- BIO-2022-0348
- Conditions
- Intubation; Difficult or Failed
- Keywords
- Intubation, Laryngoscopy, Pediatrics, Neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 29 Oct 2025 (actual)
- First posted
- 6 May 2023 (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 goal of this prospective randomized cross over clinical trial is to compare the difference in the percentage of glottic opening (POGO) between two different video laryngoscopy blades, the hyperangulated Cobalt blade and the straight Miller blade in neonates or small infants with body weight ≤ 5 kg and age ≤ 3 months.
The main questions it aims to answer are:
- Is there a significant difference in the POGO using the standard Miller video laryngoscope blade versus the non-standard hyperangulated Cobalt video laryngoscope blade in neonates and small infants?
- Are there significant differences in the first attempt success rate at intubation, the number of attempts, the time to successful intubation, the type of blade used for successful intubation, and the occurrence of adverse events during intubation, such as episodes of bradycardia or desaturation? 40 (20 in each group) neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months will be enrolled in one of the two groups over 2 years of work.
Researchers will compare the POGO and Cormack and Lehane (C\&L) classification using the hyperangulated Cobalt blade versus the straight Miller blade to identify the technique that provides optimal glottic views and intubating conditions in this patient population, and thus improved patient's safety.
Detailed description
A higher incidence of difficult airway has been reported in neonates and infants than in adults. Optimizing glottic view during tracheal intubation is very challenging in neonates and small infants and it is not clear whether the design of the intubating blade using video laryngoscopy has a major influence of the glottic view and subsequently on the success of intubation.
The primary objective of this study is to compare the difference in the percentage of glottic opening (POGO) between two different video laryngoscopy blades, the hyperangulated Cobalt blade and the straight Miller blade. The secondary objectives are the first attempt success rate at intubation, the number of attempts, the time to successful intubation, and the occurrence of adverse events during intubation, such as desaturation or bradycardia.
In this prospective randomized cross over clinical trial, 40 (20 in each group) neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months will be enrolled in one of two groups over 1 year of work. In patients allocated to the Cobalt group, the POGO and Cormack and Lehane (C\&L) classification will be recorded using video laryngoscopy with a Cobalt blade followed by an assessment using the Miller blade. In patients allocated to the Miller group, the POGO and C\&L classification will be recorded using video laryngoscopy with a Miller blade followed by an assessment using the Cobalt blade. In both groups, intubation will be attempted during the second assessment. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist.
Data comparing straight and hyperangulated video laryngoscopy blades in neonates and small infants are limited. Both techniques are standard of care at our institution. This study will identify the technique that provides optimal glottic views and intubating conditions in this patient population, and thus improved patient's safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence of NSB first | Experimental | Device: Non-standard blade (NSB), Device: Standard blade (SB)In patients allocated to the sequence of NSB first, the POGO and C\&L classification will be recorded using video laryngoscopy with the hyperangulated blade 2 followed by an assessment using the Miller blade 0 or 1. Intubation will then be attempted during the second assessment. Endotracheal tube size will be selected according to body weight and a guiding stylet will be used. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist. |
| Sequence of SB first | Placebo comparator | Device: Non-standard blade (NSB), Device: Standard blade (SB)In patients allocated to the Miller group, the POGO and C\&L classification will be recorded using video laryngoscopy with a Miller blade 0 or 1 followed by an assessment using the Cobalt blade 2. Intubation will then be attempted during the second assessment. Endotracheal tube size will be selected according to body weight and a guiding stylet will be used. If the first attempt at intubation fails, the subsequent attempts will be left at the discretion of the attending anesthesiologist. |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates or small infants with body weight ≤ 5 kg or age ≤ 3 months, scheduled for elective surgery under general anesthesia.
- ASA (American Society of Anesthesiologists) class I-III patients.
Key exclusion criteria (3 listed)
- Patients with a history of difficult airway or with craniofacial and airway anomalies.
- ASA (American Society of Anesthesiologists) class IV patients.
- Recent respiratory tract infection within the last 2 weeks.
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 |
|---|---|---|
| Non-standard blade (NSB)GlideScope® VL (Verathon Inc, WA, USA) hyperangulated blade 2 | Device | Sequence of NSB first, Sequence of SB first |
| Standard blade (SB)standard Miller blade 0 or 1 | Device | Sequence of NSB first, Sequence of SB first |
Primary outcome
POGO %
Time frame: Intraoperatively
Percentage of Glottic Opening
C&L classification
Time frame: Intraoperatively
Cormack and Lehane classification for glottic view.
3 secondary outcomes
Intubation attempts
Time frame: Intraoperatively
Time to successful tracheal intubation
Time frame: Intraoperatively
Adverse events during intubation
Time frame: Intraoperatively
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 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Intubation; Difficult or Failed
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Difficult Airway Prediction by Integrating STOP-BANG Criteria
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Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
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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.
Marie Aouad-Maroun, 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 Non-standard blade (NSB) and Standard blade (SB) in people with Intubation; Difficult or Failed, 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 2 inclusion and 3 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 Jan 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. Some participants in this study may receive a placebo. 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?
POGO % (time frame: Intraoperatively). The study lists 2 primary outcomes in all. 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 Jan 2026.