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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779528
• Other study ID #: 442/2021/67
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: January 2023
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 21, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Jordan	Jordan University Hospital	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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