Clinical trial NCT06776900: Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery
Official title: Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Video-assisted
Head and Neck Surgery
Intubation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Fiberoptic intubation was first described in the late 1960s and has since become an effective and well-established technique for airway management in awake, sedated, and anesthetized patients. This technique is especially useful in patients with known or suspected difficult airways such as those with limited mouth opening, reduced neck mobility, cervical spine injury, obesity, or an elevated risk for aspiration. The benefits of fiberoptic intubation also include fewer complications such as tooth injury and oropharyngeal bleeding; and the opportunity for optimal positioning of double-lumen tubes in patients undergoing thoracic surgery.

Anesthesiologists may be confronted with situations in which patients in a lateral position during surgery experience an accidental loss of airway patency. Intubation with direct laryngoscopy is more challenging and time-consuming in patients in the lateral position than in the supine position, particularly when there is an abrupt loss of airway patency, as demonstrated by prior research. These observations suggest that there is an unmet need for a reliable method of airway management for patients in the lateral position. Although the airway is of a larger caliber and ventilation renders less peak and better oxygenation when patients are in the lateral position, glottic view was unfavorable for intubation when Macintosh direct laryngoscope was used in this position. This could be the reason why such a procedure is unfamiliar in anesthesia even when it is the most needed in special situations. Flexible fiberoptic intubation in lateral position would be convenient in emergency situations like accidental extubation during surgery or inadequate regional anesthesia requiring general anesthesia. Flexible fiberoptic intubation in lateral position would be of significant assistance in neurosurgical patients especially those with occipital lesions and patients with difficult airway scores with limited mouth opening or neck extension.

After thorough literature review, we found that studies comparing flexible video-assisted fiberoptic intubation in the lateral versus supine position in pediatrics are lacking.


Eligibility criteria: Inclusion Criteria:

* Children aged 2-10 years old.
* Both genders.
* ASA physical status I and II.
* Elective non-head-and-neck surgeries.

Exclusion Criteria:

* Refusal of patients.
* Head and neck surgeries or with 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 low oxygen saturation (SpO2) ≤ 95% on room air.
* Trauma patients or patients requiring emergency procedures.

Primary outcomes:
measure: Time to intubation
timeFrame: 5 minutes from endoscope insertion between teeth
Secondary outcomes:
measure: Rate of successful intubation at first attempt.
timeFrame: 5 minutes from endoscope insertion between teeth
measure: Overall number of intubation attempts
timeFrame: 5 minutes from endoscope insertion between teeth
measure: Incidence of complications
timeFrame: 10 minutes from endoscope insertion between teeth
measure: Oxygen saturation
timeFrame: 5 minutes from endoscope insertion between teeth
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University
Study officials:
affiliation: Cairo University
name: Mariam KE Mohammed, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Karim KF Girgis, M.D.
role: STUDY_CHAIR
affiliation: Cairo University
name: Sherif M Soaida, M.D.
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Kareem MA Nawwar, M.D.
role: STUDY_DIRECTOR
References: