Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed; Anesthesia; Intubation;Difficult; Anesthesia Intubation Complication
• Interventions: Procedure: Fiberoptic intubation in supine position.; Procedure: Fiberoptic intubation in lateral position.

• Registration Number: NCT04779528
• Lead Sponsor: University of Jordan

Brief Summary

Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent. This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery.

Detailed Description

Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent.

This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery. The main outcome is success rate and duration of the procedure. Secondary outcomes are oxygenation maintenance, hemodynamic stability, airway complication, sedation score, and postoperative airway morbidity in 6 hours after surgery.

Study Timeline

• Study First Submitted: 2021-02-27
• Study First Submitted QC: 2021-02-27
• Study Start: 2021-03-01
• Study First Posted: 2021-03-03
• Primary Completion: 2022-02-21
• Study Completion: 2022-02-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• American Society of Anesthesiologists physical status classification two and three.
• Patients scheduled for elective bariatric surgeries under general anesthesia.

Exclusion Criteria

• Refusal of fiberoptic intubation.
• Allergy to local anesthetics.
• Coagulopathy.
• Raised intracranial or intraocular pressure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Fiberoptic intubation in supine position.	Patients will undergo fiberoptic intubation in supine position.
Group L	Fiberoptic intubation in lateral position.	Patients will undergo fiberoptic intubation in lateral position.

Primary Outcome Measures

Name	Time	Method
Duration of fiberoptic intubation.	5 minutes	The investigators will compare between the supine and lateral positions in terms of the duration needed for the insertion of an endotracheal tube via fiberoptic intubation.

Secondary Outcome Measures

Name	Time	Method
Complications during airway manipulation.	5 minutes	The investigators will document the occurrence of adverse events during fiberoptic intubation, and compare these complications between the two groups.

Trial Locations

Locations (1)

Jordan University Hospital; 🇯🇴 Amman, Jordan