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

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Beach chair (BC) and ZEEP
Reverse Trendelenburg and NIPPV
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Morbid focused on measuring Morbid Obesity, Bariatric Surgery, Pre-Oxygenation, Anesthesia Induction, Positive pressure ventilation, Non hypoxic apnea time, Positive-Pressure Respiration, Anesthesia, General

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Beach chair (BC) and ZEEP

Reverse Trendelenburg and NIPPV

Arm Description

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

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

Outcomes

Primary Outcome Measures

Non Hypoxic Apnea Time
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. End of measure time frame is 5 minutes after intubation

Secondary Outcome Measures

Time to Expired Oxygen Fraction > 0,9
Evaluation of time needed to obtain an expired fraction of oxygen of > 0,9 in the two groups during the pre-oxygenation
Maximum Expired Fraction of Oxygen Obtained
Evaluation of the maximum expired oxygen fraction obtained in the two groups
Minimum Arterial Saturation of Oxygen Obtained
Evaluation of the minimal saturation obtained after the resumption of the ventilation
Time to 97% Saturation
Hemodynamic Changes
Evaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode

Full Information

First Posted
October 6, 2015
Last Updated
March 23, 2020
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02590406
Brief Title
EPO2-A: Evaluation of Pre-Oxygenation in Morbid Obesity: Effect of Position and Positive Pressure Ventilation
Acronym
EPO2-A
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 Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Obesity prevalence in the population is increasing. Thus a growing number of obese patient need surgical interventions. These patients have a four time higher risk of suffering of serious complication in relation with their airway management compare with non-obese patients. This is explained by an increased incidence of difficulty with the ventilation and intubation of the obese. The time available for the clinician to manage the airway is define by the non hypoxic apnea time. This laps of time is dependent of the oxygen stocks of the patient, which are dependent of the functional residual capacity (FRC) and his oxygen consumption. For a non-obese patient, a normal pre-oxygenation of three minutes at 100% of oxygen allows a non hypoxic apnea time (oxygen saturation > 90%) of 8,9 minutes. However, for the morbidly obese, this time is cut to less than three minutes. The major goal of the pre-oxygenation is to increase the alveolar partial pressure of oxygen available in the end-expiratory pulmonary volume. This can be done by replacing the nitrogen in the alveolus by oxygen and by increasing the pulmonary stocks, the FRC. It has been demonstrated that the FRC after the induction of anesthesia is cut by half for the obese. This reduction is explained by a diminished thoracic compliance and an increase of the dependent lung regions' atelectasis because of a more cephalic position of the diaphragm. Various pre-oxygenation methods have been described to prolong the non hypoxic apnea time in the obese population. Some proposed pre-oxygenation strategies with the patient in the head up position (beach chair). It is a position derived from the ramped position described as the best to visualized the obese patients' glottis. Others proposed pre-oxygenation strategies with positive pressure ventilation, but only the supine position has been studied concomitantly. Individually, these techniques of pre-oxygenation are superior to the combination of supine position and no positive pressure. Indeed, studies demonstrated that the beach chair position (derived from the ramped position) or the positive pressure pre-oxygenation in supine position diminished the time needed to obtain a satisfactory pre-oxygenation (End-expiratory oxygen fraction >0,9) and a longer non hypoxic apnea time. Sill, these strategies have never been combined in the same protocol. The beach chair position without positive pressure ventilation has become the standard of care because it is the position that allows the best glottis view. Though, it has been shown by Boyce and coll. that the reverse Trendelenburg position, and not the beach chair, increased the non hypoxic apnea time, the recuperation time and the minimal saturation obtained compared to the supine position. We think that there is an advantage to use the reverse Trendelenburg position to optimize the non hypoxic apnea time. Indeed, our hypothesis is that there will be less pressure on the diaphragm in comparison with the beach char position. A studied realized by our group (EPO2-PV) evaluated the effect of three positions (Reverse Trendelenburg, beach chair and supine) and two ventilation strategies (spontaneous ventilation with or without positive pressure) on morbidly obese FRC in laboratory. The results showed a statistically significant difference on the FRC after a pre-oxygenation with positive pressure compared with the pre-oxygenation without positive pressure, and this regardless of the position. Moreover, for both ventilation strategies, results demonstrated a statistically significant superiority between the FRC obtained after pre-oxygenation in reverse Trendelenburg compared with the beach chair and the supine position. No improvement has been shown with the beach chair position. Thereby, the current study will try to correlate the FRC results obtained in laboratory in actual non hypoxic apnea time in the operating room. This research design tries to compare, in patient receiving general anesthesia for bariatric surgeries, the effect of the pre-oxygenation with positive pressure and the reverse Trendelenburg position, on the non hypoxic apnea time in comparison with the actual standard of care, beach chair position without positive pressure ventilation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Morbid Obesity, Bariatric Surgery, Pre-Oxygenation, Anesthesia Induction, Positive pressure ventilation, Non hypoxic apnea time, Positive-Pressure Respiration, Anesthesia, General

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beach chair (BC) and ZEEP
Arm Type
Active Comparator
Arm Description
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
Arm Title
Reverse Trendelenburg and NIPPV
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Beach chair (BC) and ZEEP
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Reverse Trendelenburg and NIPPV
Intervention Description
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 Measure Information:
Title
Non Hypoxic Apnea Time
Description
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. End of measure time frame is 5 minutes after intubation
Time Frame
After a 3 minutes pre-oxygenation period
Secondary Outcome Measure Information:
Title
Time to Expired Oxygen Fraction > 0,9
Description
Evaluation of time needed to obtain an expired fraction of oxygen of > 0,9 in the two groups during the pre-oxygenation
Time Frame
During the pre-oxygenation period
Title
Maximum Expired Fraction of Oxygen Obtained
Description
Evaluation of the maximum expired oxygen fraction obtained in the two groups
Time Frame
After 3 minutes of pre-oxygenation
Title
Minimum Arterial Saturation of Oxygen Obtained
Description
Evaluation of the minimal saturation obtained after the resumption of the ventilation
Time Frame
After the end of the Non-hypoxic apnea time
Title
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%
Title
Hemodynamic Changes
Description
Evaluation of the changes in vital signs during and after the pre-oxygenation phase in the two combinations of position and ventilation mode
Time Frame
From the beginning of the pre-oxygenation to the end of the protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antony Carrier-Boucher, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bussières S Jean, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec city
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

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

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