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

Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position: a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Intubation; Difficult or Failed; Anesthesia Intubation Complication; Intubation;Difficult
• Intervention / Treatment: Procedure: Fiberoptic intubation in supine position.; Procedure: Fiberoptic intubation in lateral position.

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; Patients will undergo fiberoptic intubation in supine position.	Procedure: Fiberoptic intubation in supine position.; Patients will be placed in supine position after the establishment of full vital signs monitoring and the insertion of an intravenous line. Under sedation via intravenous infusion of remifentanil plus topical anesthesia with 10 ml of Lidocaine 1% via a 3.7mm bronchoscope. After applying a standard monitoring and preparation of the nose by decongestant and local anesthesia. A loaded flexible scope (by an endotracheal tube ETT) will be introduced through the nostril to reach the carina, then the ETT will be pushed over the scope 3cm above the carina.
Experimental: Group L; Patients will undergo fiberoptic intubation in lateral position.	Procedure: Fiberoptic intubation in lateral position.; Patients will be placed in lateral position after the establishment of full vital signs monitoring and the insertion of an intravenous line. Under sedation via intravenous infusion of remifentanil plus topical anesthesia with 10 ml of Lidocaine 1% via a 3.7mm bronchoscope. After applying a standard monitoring and preparation of the nose by decongestant and local anesthesia. A loaded flexible scope (by an endotracheal tube ETT) will be introduced through the nostril to reach the carina, then the ETT will be pushed over the scope 3cm above the carina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of fiberoptic intubation.	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.	5 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: obesity; Anesthesia; Intubation; fiberoptic
• Other Study ID Numbers: 442/2021/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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