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

Sponsor
University of Jordan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04779528
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Fiberoptic intubation in supine position.
  • Procedure: Fiberoptic intubation in lateral position.
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position: a Prospective Randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jordan University Hospital Amman Jordan 11942

Sponsors and Collaborators

  • University of Jordan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
omar ahmad ababneh, Principal investigator, University of Jordan
ClinicalTrials.gov Identifier:
NCT04779528
Other Study ID Numbers:
  • 442/2021/67
First Posted:
Mar 3, 2021
Last Update Posted:
May 13, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by omar ahmad ababneh, Principal investigator, University of Jordan
Anesthesia
Intubation
obesity
fiberoptic

Study Results

No Results Posted as of May 13, 2021