Trial Outcomes & Findings for EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode (NCT NCT02121808)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

After a 5 minutes pre-oxygenation period

Results posted on

2018-04-09

Participant Flow

Recruitment was held between April 14th 2014 and June 26th 2014 by telephonic solicitation and through the preoperative bariatric clinic of our institution.

Participant milestones

Participant milestones
Measure	Position and Spontaneous vs Pressure Support The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order. Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Position and Spontaneous vs Pressure Support The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order. Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation
Overall Study Technical problem	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Position and Spontaneous vs Pressure Support n=17 Participants The effect of position and spontaneous vs pressure support ventilation on FRC was assessed on patients recruited. The six possible combination were tested on every patients in a randomized order. Intervention 1 : Supine + NIPPV Intervention 2 : Supine + Tidal volume spontaneous ventilation Intervention 3 : Beach chair (Back 25 deg) + NIPPV Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation Intervention 5 : Proclive (Global 25 deg) + NIPPV Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation
Age, Continuous	40 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
BMI	50 kg/m2 STANDARD_DEVIATION 8 • n=5 Participants
Waist circumference	143 cm STANDARD_DEVIATION 17 • n=5 Participants

PRIMARY outcome

Timeframe: After a 5 minutes pre-oxygenation period

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.

Outcome measures

Outcome measures
Measure	1. Supine + NIPPV n=17 Participants Intervention 1 : Supine + NIPPV	2. Supine + Tidal Volume Spontaneous Ventilation n=17 Participants Intervention 2 : Supine + Tidal volume spontaneous ventilation	3. Beach Chair (Back 25 Deg) + NIPPV n=17 Participants Intervention 3 : Beach chair (Back 25 deg) + NIPPV	4. Beach Chair (Back 25 Deg) + Tidal Volume Spontaneous Ventil n=17 Participants Intervention 4 : Beach chair (Back 25 deg) + Tidal volume spontaneous ventilation	5. Proclive (Global 25 Deg) + NIPPV n=17 Participants Intervention 5 : Proclive (Global 25 deg) + NIPPV	6. Proclive (Global 25 Deg) + Tidal Volume Spontaneous Ventila n=17 Participants Intervention 6 : Proclive (Global 25 deg) + Tidal volume spontaneous ventilation
Functional Residual Capacity	2573 ml Standard Deviation 515	2145 ml Standard Deviation 438	2456 ml Standard Deviation 442	2219 ml Standard Deviation 477	2684 ml Standard Deviation 473	2282 ml Standard Deviation 501

SECONDARY outcome

Timeframe: After a 5 minutes pre-oxygenation period

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of a 5 minutes pre-oxygenation period

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At the end of a 5 minutes pre-oxygenation period

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At the end of a 5 minutes pre-oxygenation period

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.

Outcome measures

Outcome data not reported

Adverse Events

Position and Spontaneous vs Pressure Support

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean S. Bussières

Laval University

Phone: 418 656-8711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place