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EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode (EPO2-PV)

Primary Purpose

Morbid Obesity, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NIPPV
Tidal volume
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring Morbid Obesity, Bariatric Surgery Candidate, Pre-Oxygenation, Functional Residual Capacity

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • BMI 40 - 80 kg / m2
  • Waist circumference: Men: More than 130 cm
  • Waist circumference: Women: More than 115 cm

Exclusion Criteria:

  • Facial hair
  • Cranio-facial abnormality
  • Claustrophobia
  • Asthma
  • COPD (defined by FEV1 < 80 %)
  • Severe cardiovascular disease (defined by NYHA ≥3)
  • Pregnancy
  • Tobacco use
  • NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).

Sites / Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Supine

Beach-chair (Back : 25 deg)

Proclive (Global 25 deg)

Arm Description

NIPPV and Tidal volume

NIPPV and Tidal volume

NIPPV and Tidal volume

Outcomes

Primary Outcome Measures

Functional Residual Capacity
Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.

Secondary Outcome Measures

Diaphragmatic Amplitude.
Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Respiratory Mechanics
Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Patient's Comfort
Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.

Full Information

First Posted
April 22, 2014
Last Updated
September 14, 2017
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02121808
Brief Title
EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode
Acronym
EPO2-PV
Official Title
Evaluation of Different Pre-Oxygenation Conditions in Morbid Obesity: Position and Ventilation Mode, in a Respiratory Physiology Laboratory, on Voluntary Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature. This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.
Detailed Description
Complications related to airway management are the major contributing factor to morbidity in anesthesiology. This risk of complications markedly increases when faced with a difficult airway in an obese patient. Pre-oxygenation creates a safety margin by increasing the patient's oxygen stores, through a higher functional residual capacity (FRC). When pre-oxygenated, the clinician may proceed to intubation after a variable period of apnea, while maintaining oxygen saturation over 92%. In non-obese individuals, pre-oxygenation allows a non-hypoxic apnea time of eight minutes. In the obese population, however, this non-hypoxic apnea time decreases to two to three minutes. Different methods of pre-oxygenation have been proposed in order to increase apnea time before significant oxygen desaturation. Amongst these methods, the following are of particular interest: pre-oxygenation to vital capacity, pre-oxygenation with spontaneous ventilation and positive pressure, and pre-oxygenation with elevated head positioning ("beach-chair"). These methods have been extensively studied in individuals of normal height and weight. The main objective of pre-oxygenation is to raise oxygen levels available at the alveolar level in order to increase the non-hypoxic apnea time, before a significant desaturation occurs. This raised alveolar oxygen concentration can be done by maintaining a higher inspired oxygen fraction and by promoting a larger FRC which is the oxygen reserve build through the pre-oxygenation phase. In morbid obese patients, these parameters are affected by a lower expiratory flow, lower expiratory flow and closing of small radius airways. The final result probably come from a more cephalad position of the diaphragm induced by a larger intra-abdominal volume. Actually, different studies demonstrate the advantage of a beach-chair position and non-invasive positive pressure ventilation for pre-oxygenation of obese patients. These advantages are shown by a shorter time of pre-oxygenation to obtain an end-tidal O2 > 90 % and a longer non-hypoxic apnea time (Sat O2 >90%). Up to date, there is no published data on the FRC as a result of different combinations of position and ventilation mode. This study will evaluate FRC by helium dilution technique. We propose a crossover randomised trial on volunteers waiting for a bariatric surgery. We want to compare, in pre-oxygenation situation, without induction of general anesthesia, the effect of three positions and two ventilation modes on the FRC measure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Bariatric Surgery Candidate
Keywords
Morbid Obesity, Bariatric Surgery Candidate, Pre-Oxygenation, Functional Residual Capacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supine
Arm Type
Experimental
Arm Description
NIPPV and Tidal volume
Arm Title
Beach-chair (Back : 25 deg)
Arm Type
Experimental
Arm Description
NIPPV and Tidal volume
Arm Title
Proclive (Global 25 deg)
Arm Type
Experimental
Arm Description
NIPPV and Tidal volume
Intervention Type
Procedure
Intervention Name(s)
NIPPV
Intervention Description
Ventilation: non-invasive positive pressure ventilation (NIPPV) Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)
Intervention Type
Procedure
Intervention Name(s)
Tidal volume
Intervention Description
Tidal volume spontaneous ventilation, no assistance.
Primary Outcome Measure Information:
Title
Functional Residual Capacity
Description
Change of functional residual capacity (FRC), in obese patient, as a result of different pre-oxygenation positions; 1- supine, 2-beach-chair, 3- reverse Trendelenburg, in two different ventilation modes : 1- spontaneous ventilation at tidal volume, 2- non-invasive positive pressure ventilation with inspiratory assistance.
Time Frame
After a 5 minutes pre-oxygenation period
Secondary Outcome Measure Information:
Title
Diaphragmatic Amplitude.
Description
Evaluation of changes in diaphragmatic amplitude and movement determined by fluoroscopy imaging after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time Frame
After a 5 minutes pre-oxygenation period
Title
Respiratory Mechanics
Description
Change in respiratory mechanics (compliance, resistance, tidal volume, positive end-expiratory pressure, maximal inspiratory pressure) evaluated at the end of a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time Frame
At the end of a 5 minutes pre-oxygenation period
Title
Patient's Comfort
Description
Evaluation of the patient's comfort at the end of each intervention on an analog visual scale after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time Frame
At the end of a 5 minutes pre-oxygenation period
Other Pre-specified Outcome Measures:
Title
Vital Signs
Description
Change in vital signs before and after the pre-oxygenation phase in the 6 combinations after a 5 minutes pre-oxygenation period in the 6 combinations previously described.
Time Frame
At the end of a 5 minutes pre-oxygenation period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 40 - 80 kg / m2 Waist circumference: Men: More than 130 cm Waist circumference: Women: More than 115 cm Exclusion Criteria: Facial hair Cranio-facial abnormality Claustrophobia Asthma COPD (defined by FEV1 < 80 %) Severe cardiovascular disease (defined by NYHA ≥3) Pregnancy Tobacco use NI-CPPV Intolerance documented by a respiratory specialist (pneumologist).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne J Couture, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean S Bussières, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec
City
Quebec city
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada

12. IPD Sharing Statement

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EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode

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