Actively Recruiting
Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial
Led by Cairo University · Updated on 2025-01-22
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fiberoptic intubation is a well-established technique for managing airways in patients who are awake, sedated, or under anesthesia. This method is especially helpful for patients with difficult airways, such as those with limited mouth opening, neck mobility issues, or higher risk of aspiration. The study addresses the challenge of performing intubation in pediatric patients aged 2 to 10 years undergoing non-head-and-neck surgeries, comparing fiberoptic intubation in the lateral versus supine positions, as there is limited research in children on this topic. Participants will be randomly assigned to two groups: one group will have fiberoptic intubation performed in the supine position with the head placed neutrally and a roll under the shoulders, while the other group will be positioned laterally with proper head and neck alignment, a flexed dependent leg, and a pillow between the legs. In both groups, an assistant will hold the tongue forward using gauze and forceps while the operator advances the bronchoscope to visualize the laryngeal inlet and pass the endotracheal tube into the trachea. If oxygen saturation falls to 90%, the intubation will pause for ventilation until levels return to 100%. During the study, researchers will measure the time to intubation, success rate at the first attempt, the total number of attempts, complication rates, and oxygen saturation within specified time frames after bronchoscope insertion. Confirmation of successful intubation will be done using chest auscultation and capnography. The trial is randomized without blinding and aims to assess whether fiberoptic intubation in the lateral position is not inferior to the supine position, with participation lasting throughout the surgical procedure and immediate monitoring after intubation.
CONDITIONS
Brief Title
Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 10 years old
- Both genders
- ASA physical status I and II
- Elective non-head-and-neck surgeries
You will not qualify if you...
- Refusal of patients
- Head and neck surgeries or history of previous ones
- Head, neck, and lung congenital deformities or pathologies
- Patients with expected difficult intubation based on examination
- Patients with neuromuscular disorders
- Hypoxia defined as oxygen saturation (SpO2) ≤ 95% on room air
- Trauma patients or patients requiring emergency procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo fiberoptic intubation either in the lateral or supine position during elective non-head-and-neck surgery.
1 procedure visit (in-person)
Duration - Up to 10 minutes after intubation
Participants are monitored for intubation success, complications, and oxygen saturation after the procedure.
Post-procedure observation during the surgery day
Trial Site Locations
Total: 1 location
1
Faculty of Medicine, Cairo University
Cairo, Egypt
Actively Recruiting
Research Team
K
Kareem MA Nawwar, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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