Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery

Video-assisted Fiberoptic Intubation in Lateral Versus Supine Position in Pediatrics Undergoing Non-head-and-neck Surgery: a Randomized Controlled Non-inferiority Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation; Head and Neck Surgery; Video-assisted
• Intervention / Treatment: Procedure: Supine position; Procedure: Lateral position

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kareem MA Nawwar, M.D.; Phone Number: +201003878369; Email: drknawwar@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of medicine, Cairo University
    • Contact: Kareem MA Nawwar; Phone Number: +201003878369; Email: drknawwar@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supine group; the patient will be kept in supine position with the head placed neutrally and a roll under the shoulders	Procedure: Supine position; An assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10). The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to glide the suitable ETT into the trachea. Once the ETT is connected to the mechanical ventilator, chest auscultation and capnography waves will be used to confirm a successful intubation. At any intubation attempt where SpO2 reaches 90%, the procedure will be suspended and mechanical ventilation via a facemask applied till SpO2 of 100% achieved.
Active Comparator: Lateral group; the patient will be positioned in the lateral position with head and neck physiologically aligned with head positioner. The dependent leg will be flexed at the hip and knee and the upper leg will be straight with a pillow between both legs	Procedure: Lateral position; An assistant will be asked to hold the tongue in protrusion using a gauze held by a Magill forceps (preventing it from falling backwards). The operator will introduce the bronchoscope orally allowing its advancement till it reaches the laryngeal inlet. The glottic view will be graded from 1 (larynx is only seen) to 5 (the epiglottis down folded and larynx cannot be seen directly) (10). The scope will be manipulated to pass between the 2 vocal cords, and then advanced till the carina is seen to glide the suitable ETT into the trachea. Once the ETT is connected to the mechanical ventilator, chest auscultation and capnography waves will be used to confirm a successful intubation. At any intubation attempt where SpO2 reaches 90%, the procedure will be suspended and mechanical ventilation via a facemask applied till SpO2 of 100% achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to intubation	time from inserting the endoscope between teeth in the first intubation attempt, till successful display of end tidal carbon dioxide (ETCO2) waveform on capnography	5 minutes from endoscope insertion between teeth

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful intubation at first attempt.	each intubation trial will be labelled as successful from first, second or third attempt or failed	5 minutes from endoscope insertion between teeth
Overall number of intubation attempts	each intubation trial will be labelled as successful from first, second or third attempt or failed	5 minutes from endoscope insertion between teeth
Incidence of complications	Oesophageal intubation, Lip, tongue or dental injury, Oxygen desaturation (SpO2 ≤ 92%), or Bronchospasm	10 minutes from endoscope insertion between teeth
Oxygen saturation	just before and immediately after successful intubation	5 minutes from endoscope insertion between teeth

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Sherif M Soaida, M.D., Cairo University; Study Director: Kareem MA Nawwar, M.D., Cairo University; Principal Investigator: Mariam KE Mohammed, MBBCh, Cairo University; Study Chair: Karim KF Girgis, M.D., Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2025
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 10, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MS-526-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No