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

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Head and Neck Surgery
Video-assisted
Intubation

Treatments

Procedure: Supine position
Procedure: Lateral position

Study type

Interventional

Funder types

Other

Identifiers

NCT06776900
MS-526-2024

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

2 to 10 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Supine group
Active Comparator group
Description:
the patient will be kept in supine position with the head placed neutrally and a roll under the shoulders
Treatment:
Procedure: Supine position
Lateral group
Active Comparator group
Description:
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
Treatment:
Procedure: Lateral position

Trial contacts and locations

1

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Central trial contact

Kareem MA Nawwar, M.D.

Data sourced from clinicaltrials.gov

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