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

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ClinicalTrials.gov Identifier: NCT03046797
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
AlRefaey Kandeel, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Fibroptic intubation through Boussignac valve opening Device: Classic Fibroptic intubation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Boussignac Valve and Fibroptic Intubation in Morbidly Obese Patients, Can it be a Solution?
Actual Study Start Date : February 5, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : December 30, 2017

Arm Intervention/treatment
Experimental: B group
Mask ventilation will be continued and fiberoptic intubation will be performed from Boussignac valve opening by an experienced anesthetist.
Device: Fibroptic intubation through Boussignac valve opening
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.

Active Comparator: C group
mask ventilation will be terminated then fiberoptic intubation will be done by an experienced anesthetist.
Device: Classic Fibroptic intubation
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 Measures :
  1. number of desaturation events [ Time Frame: 3 minutes after the start of intubation attempt ]
    desaturation (spo2 less than 94) during fibroptic intubation of morbidly obese patients



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046797


Locations
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Egypt
Mansoura university
Mansourah, Dkahleya, Egypt
Gastroenterology center
Mansourah, Egypt, 35516
Sponsors and Collaborators
Mansoura University
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Responsible Party: AlRefaey Kandeel, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT03046797    
Other Study ID Numbers: Obese-FOB
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight