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Trial record 4 of 603 for:    "Obesity, Morbid"

EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation (EPO2-A)

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ClinicalTrials.gov Identifier: NCT02590406
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Laval University

Brief Summary:
The risk of complication associated with airway in obese patient is important. The result of pre-oxygenation gives the clinician a prolonged non-hypoxic apnea time. The relation between FRC and non-hypoxic apnea time has been correlated. However, the best condition to accomplish the pre-oxygenation in morbidly obese patient has yet to be described in the medical literature. A study previously done in our hospital (EPO2-PV) compared the effect of different positions and ventilation modes on the FRC in the laboratory. A significant difference has been established on the FRC between the inverse Trendelenburg position with positive pressure ventilation and the head up ("beach-chair") position without positive pressure. The current study, EPO2-A is designed to compared the two positions and ventilation modes during the induction of general anesthesia on morbidly obese and correlate the difference in FRC to difference in apnea time.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: Beach chair (BC) and ZEEP Procedure: Reverse Trendelenburg and NIPPV Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: EPO2-A: Evaluation of Different Pre-Oxygenation Condition in Morbid Obesity: Effect of Position and Positive Pressure Ventilation During General Anesthesia Induction
Study Start Date : September 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Beach chair (BC) and ZEEP
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
Procedure: Beach chair (BC) and ZEEP
Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface

Experimental: Reverse Trendelenburg and NIPPV

Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.

NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface

Procedure: Reverse Trendelenburg and NIPPV

Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.

NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface





Primary Outcome Measures :
  1. Non hypoxic apnea time [ Time Frame: After a 3 minutes pre-oxygenation period ]
    Change of Non-hypoxic apnea time in obese patient during a General Anesthesia induction, as a result of different pre-oxygenation position and ventilation mode; 1-Beach Chair and No positive pressure ventilation, 2-Reverse Trendelenburg and positive pressure ventilation and PEEP


Secondary Outcome Measures :
  1. Time to expired oxygen fraction > 0,9 [ Time Frame: During the pre-oxygenation period ]
    Evaluation of time needed to obtain an expired fraction of oxygen of > 0,9 in the two groups during the pre-oxygenation

  2. Maximum expired fraction of oxygen obtained [ Time Frame: After 3 minutes of pre-oxygenation ]
    Evaluation of the maximum expired oxygen fraction obtained in the two groups

  3. Minimum arterial saturation of oxygen obtained [ Time Frame: After the end of the Non-hypoxic apnea time ]
    Evaluation

  4. Time to 97% saturation [ Time Frame: Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97% ]
  5. Hemodynamic changes [ Time Frame: From the beginning of the pre-oxygenation to the end of the protocol ]
    Evaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 40
  • Abdominal obesity : waist circumference: > 115 for the women waist circumference > 130 for the men

Exclusion Criteria:

  • Facial hair
  • Cranio-facial abnormality
  • Asthma (continuous treatment)
  • COPD (FEV1 < 80%)
  • Severe cardiovascular disease (NYHA > 3)
  • Pregnancy
  • Tobacco use
  • Know or suspected difficulty with intubation
  • Severe GERD or risk of aspiration

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): NCT02590406


Locations
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Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec
Québec city, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Antony Carrier-Boucher, MD Laval University
Principal Investigator: Bussières S Jean, MD Laval University

Publications of Results:
Other Publications:

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Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT02590406     History of Changes
Other Study ID Numbers: IUCPQ 21211
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by Laval University:
Morbid Obesity
Bariatric Surgery
Pre-Oxygenation
Anesthesia Induction
Positive pressure ventilation
Non hypoxic apnea time
Positive-Pressure Respiration
Anesthesia, General
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs