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

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fibroptic intubation through Boussignac valve opening
Classic Fibroptic intubation
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

  • Mansoura university
  • Gastroenterology center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

B group

C group

Arm Description

Mask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist.

mask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist.

Outcomes

Primary Outcome Measures

number of desaturation events
desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients

Secondary Outcome Measures

Full Information

First Posted
February 5, 2017
Last Updated
January 4, 2018
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03046797
Brief Title
Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
Acronym
Obese-FOB
Official Title
Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 5, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
All patients will be subjected to a thorough preoperative evaluation including clinical assessment, ECG, Echocardiography, pulmonary function tests and laboratory investigations (CBC, SGOT, SGPT, Albumin, Serum creatinine) and basal arterial blood gases. All patients will be pre-medicated with intravenous infusion of pantoprazole (40 mg) and metoclopramide (10 mg). After pre-oxygenation with 100% oxygen for 5 minutes, anesthesia will be induced using propofol (1-2 mg/kg) preceded by 60 mgs of lidocaine, and rocronium (0.12 mg/kg). Mask ventilation will be maintained while a Boussignac valve is attached between the Y-circuit and the face mask. After full relaxation is achieved (60 second after TOF response disappears), intubation attempt will commence. Intubation technique: Patients of both, patients will be put in HELP position to facilitate both ventilation and incubation In C group: mask ventilation will be terminated then FOB intubation will be done by experienced anesthist. In B group: Mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening. Data collection: Patient demographic data (Age, Weight, height, BMI, ASA status, coexisting diseases) will be collected. Hemodynamic parameters will be r5ecorded at the following points (Preoperative, basal, 1,2,3 minutes after starting intubation attempt). Time to successful intubation will be documented in seconds (starting from passing of FOB through mouth opening till successful placement of the tube in the trachea). Also, time to glottis visualization and time to carina visualization will be recorded. Number of attempts will be also recorded where unsuccessful attempt will be defined as the need to withdraw FOB outside the patient's mouth (either due to failure to progress or need for ventilation). a desaturation event will be defined as SpO2 less than 94. Also, any procedure-related complication will be documented (hypertension, arrhythmia, spasm, bleeding) Statistical analysis G*power software version 3.1.9.2 was used for sample size calculation. We assumed that using Boussignac valve during FOB intubation can produce a 20% increase in the time to reach patients spo2 of 95% (180±20 sec in previous studies). It was found that 16 patients per was required to achieve a power of 90% with an alpha error of 0.05. additional 4 patients were added to compensate or dropouts making a total sample size of 40 patients. Data will be collected and tabulated in excel sheet (Microsoft office, 2016). Statistical analysis will be performed using SPSS software version 20. Continuous data will be tested for normality of distribution and presented as mean±SD or median (interquartile range). Statistical differences between the studied groups will be assessed using appropriate statistical tests

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B group
Arm Type
Experimental
Arm Description
Mask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist.
Arm Title
C group
Arm Type
Active Comparator
Arm Description
mask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist.
Intervention Type
Device
Intervention Name(s)
Fibroptic intubation through Boussignac valve opening
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Classic Fibroptic intubation
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of desaturation events
Description
desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients
Time Frame
3 minutes after the start of intubation attempt

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Facility Information:
Facility Name
Mansoura university
City
Mansourah
State/Province
Dkahleya
Country
Egypt
Facility Name
Gastroenterology center
City
Mansourah
ZIP/Postal Code
35516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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