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NCT Number: NCT06776900

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

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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University

Cairo, Egypt

Location status: Recruiting

Location contact

Kareem MA Nawwar

CONTACT

[email protected]

+201003878369

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supine position

Procedure

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.

Lateral position

Procedure

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.

Primary outcomes

  1. Time to intubation

    Time frame: 5 minutes from endoscope insertion between teeth

    time from inserting the endoscope between teeth in the first intubation attempt, till successful display of end tidal carbon dioxide (ETCO2) waveform on capnography

Secondary outcomes

  1. Rate of successful intubation at first attempt.

    Time frame: 5 minutes from endoscope insertion between teeth

    each intubation trial will be labelled as successful from first, second or third attempt or failed

  2. Overall number of intubation attempts

    Time frame: 5 minutes from endoscope insertion between teeth

    each intubation trial will be labelled as successful from first, second or third attempt or failed

  3. Incidence of complications

    Time frame: 10 minutes from endoscope insertion between teeth

    Oesophageal intubation, Lip, tongue or dental injury, Oxygen desaturation (SpO2 ≤ 92%), or Bronchospasm

  4. Oxygen saturation

    Time frame: 5 minutes from endoscope insertion between teeth

    just before and immediately after successful intubation

Study contacts

Contact information is provided by the study sponsor or research team.

Kareem MA Nawwar, M.D.

CONTACT

[email protected]

+201003878369

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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