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NCT Number: NCT04779528

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

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.

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Key information

Conditions

Anesthesia Anesthesia Intubation Complication Body Weight Intubation; Difficult or Failed Intubation;Difficult Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Duration of fiberoptic intubation.

    Time frame: 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 outcomes

  1. Complications during airway manipulation.

    Time frame: 5 minutes

    The investigators will document the occurrence of adverse events during fiberoptic intubation, and compare these complications between the two groups.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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