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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06776900
Enrollment
50
Registered
2025-01-15
Start date
2025-01-18
Completion date
2025-08-31
Last updated
2025-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Video-assisted, Head and Neck Surgery, Intubation

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.

Interventions

PROCEDURESupine 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.

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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to intubation5 minutes from endoscope insertion between teethtime from inserting the endoscope between teeth in the first intubation attempt, till successful display of end tidal carbon dioxide (ETCO2) waveform on capnography

Secondary

MeasureTime frameDescription
Rate of successful intubation at first attempt.5 minutes from endoscope insertion between teetheach intubation trial will be labelled as successful from first, second or third attempt or failed
Overall number of intubation attempts5 minutes from endoscope insertion between teetheach intubation trial will be labelled as successful from first, second or third attempt or failed
Incidence of complications10 minutes from endoscope insertion between teethOesophageal intubation, Lip, tongue or dental injury, Oxygen desaturation (SpO2 ≤ 92%), or Bronchospasm
Oxygen saturation5 minutes from endoscope insertion between teethjust before and immediately after successful intubation

Countries

Egypt

Contacts

Primary ContactKareem MA Nawwar, M.D.
drknawwar@cu.edu.eg+201003878369

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026