Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03046797
• Date of registration: 05/02/2017
• Prospective Registration: Yes
• Primary sponsor: Mansoura University
• Public title: Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution? Obese-FOB
• Scientific title: Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
• Date of first enrolment: February 5, 2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03046797
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Egypt

Key inclusion & exclusion criteria

Inclusion Criteria:

- Morbidly obese patients (BMI above 40kg/m2) scheduled for elective surgery, with age
between 20 to 45 years

Exclusion Criteria:

- unstable ischemic heart disease, uncontrolled systemic hypertension, previous history
of difficult intubation and patients with basal oxygen saturation less than 94%



Age minimum: 20 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Morbid Obesity

Intervention(s)

Device: Fibroptic intubation through Boussignac valve opening

Device: Classic Fibroptic intubation

Primary Outcome(s)

number of desaturation events [Time Frame: 3 minutes after the start of intubation attempt]

Secondary ID(s)

Obese-FOB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors