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

March 23, 2020 updated by: Laval University

EPO2-A: Evaluation of Different Pre-Oxygenation Condition in Morbid Obesity: Effect of Position and Positive Pressure Ventilation During General Anesthesia Induction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec city, Quebec, Canada, G1V4G5
        • Institut Universitaire de cardiologie et de pneumologie de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. End of measure time frame is 5 minutes after intubation
After a 3 minutes pre-oxygenation period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the pre-oxygenation period
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
After 3 minutes of pre-oxygenation
Minimum Arterial Saturation of Oxygen Obtained
Time Frame: After the end of the Non-hypoxic apnea time
Evaluation of the minimal saturation obtained after the resumption of the ventilation
After the end of the Non-hypoxic apnea time
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%
Evaluation of the time needed to the beginning of the ventilation to the moment where the saturation is 97%
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
From the beginning of the pre-oxygenation to the end of the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Antony Carrier-Boucher, MD, Laval University
  • Principal Investigator: Bussières S Jean, MD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUCPQ 21211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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