Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
Obese-FOB
1 other identifier
interventional
50
1 country
2
Brief Summary
In this study, fiberoptic intubation through Boussignac valve, while ventilation of morbidly obese patients is maintained through the ventilator, will be studied. Researchers suggest that the technique will allow more time for intubation trial rather than conventional techniques of intubation without ventilation. the Primary outcome will be the decrease of desaturation events during intubation. Secondary variables will include; stress response to intubation, the incidence of hypercapnia, hemodynamic response to intubation, successful intubation, the time required to intubation and operator satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2017
CompletedStudy Start
First participant enrolled
February 5, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2017
CompletedJanuary 8, 2018
January 1, 2018
11 months
February 5, 2017
January 4, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
number of desaturation events
desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients
3 minutes after the start of intubation attempt
Study Arms (2)
B group
EXPERIMENTALMask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist.
C group
ACTIVE COMPARATORmask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist.
Interventions
After patients being put in HELP position to facilitate both ventilation and intubation, mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.
After patients being put in HELP position to facilitate both ventilation and incubation, mask ventilation will be terminated then FOB intubation will be done by an experienced anesthetist.
Eligibility Criteria
You may qualify if:
- Morbidly obese patients (BMI above 40kg/m2) scheduled for elective surgery, with age between 20 to 45 years
You may not qualify if:
- unstable ischemic heart disease, uncontrolled systemic hypertension, previous history of difficult intubation and patients with basal oxygen saturation less than 94%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mansoura university
Al Mansurah, Dkahleya, Egypt
Gastroenterology center
Al Mansurah, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 5, 2017
First Posted
February 8, 2017
Study Start
February 5, 2017
Primary Completion
December 30, 2017
Study Completion
December 30, 2017
Last Updated
January 8, 2018
Record last verified: 2018-01