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

NCT04779528 | Completed

• 1 other identifier: 442/2021/67
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Intubation;Difficult; Intubation; Difficult or Failed; Anesthesia Intubation Complication

Keywords

Anesthesia; Intubation; obesity; fiberoptic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complications during airway manipulation.

  5 minutes

Study Arms (2)

Group S

EXPERIMENTAL

Patients will undergo fiberoptic intubation in supine position.

Procedure: Fiberoptic intubation in supine position.

Group L

EXPERIMENTAL

Patients will undergo fiberoptic intubation in lateral position.

Procedure: Fiberoptic intubation in lateral position.

Interventions

Fiberoptic intubation in supine position. PROCEDURE

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.

Group S

Fiberoptic intubation in lateral position. PROCEDURE

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.

Group L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Obesity

Interventions

Supine Position

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 27, 2021
• First Posted: March 3, 2021
• Study Start: March 1, 2021
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)