Trial Outcomes & Findings for Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia (NCT NCT02313766)

Results Overview

Time measured form face mask positioning until FEO2 reached 90% on the gas monitor

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

up to 5 min

Results posted on

2016-04-14

Participant Flow

Planned Recruitment period : from october 01,2006 to october 31,2007 The day of surgery, the patient was randomly allocated (random number table, equilibration block sizes of 15)

patients received oral information and signed a written informed consent at the end of the preanaesthesia medical consultation

Participant milestones

Participant milestones
Measure	Spontaneous Breathing (SB) preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP	PPV + PEEP PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90% PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)
Overall Study STARTED	50	50	50
Overall Study COMPLETED	49	47	50
Overall Study NOT COMPLETED	1	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Spontaneous Breathing (SB) preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP
Overall Study surgery cancelled	1	0
Overall Study Lost to Follow-up	0	2
Overall Study Adverse Event	0	1

Baseline Characteristics

Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spontaneous Breathing (SB) n=49 Participants preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) n=47 Participants PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP	PPV + PEEP n=50 Participants PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90% PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	42 Participants n=7 Participants	41 Participants n=5 Participants	125 Participants n=4 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	21 Participants n=4 Participants
Age, Continuous	45 years STANDARD_DEVIATION 18 • n=5 Participants	40 years STANDARD_DEVIATION 17 • n=7 Participants	45 years STANDARD_DEVIATION 20 • n=5 Participants	44 years STANDARD_DEVIATION 19 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	66 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	23 Participants n=7 Participants	30 Participants n=5 Participants	80 Participants n=4 Participants
Region of Enrollment France	49 participants n=5 Participants	47 participants n=7 Participants	50 participants n=5 Participants	146 participants n=4 Participants

PRIMARY outcome

Timeframe: up to 5 min

Time measured form face mask positioning until FEO2 reached 90% on the gas monitor

Outcome measures

Outcome measures
Measure	Spontaneous Breathing (SB) n=49 Participants preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) n=47 Participants PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP	PPV + PEEP n=50 Participants PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90% PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)
Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%	190 seconds Interval 130.0 to 264.0	153 seconds Interval 120.0 to 218.0	140 seconds Interval 100.0 to 200.0

SECONDARY outcome

Timeframe: up to 10 min

time until SpO2=93% after endotracheal tube placement has been confirmed

Outcome measures

Outcome measures
Measure	Spontaneous Breathing (SB) n=49 Participants preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) n=47 Participants PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP	PPV + PEEP n=50 Participants PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90% PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)
Time Until SpO2=93%	305 seconds Interval 263.0 to 383.0	370 seconds Interval 300.0 to 450.0	345 seconds Interval 245.0 to 435.0

SECONDARY outcome

Timeframe: Before PACU leaving

discomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving

Outcome measures

Outcome measures
Measure	Spontaneous Breathing (SB) n=49 Participants preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) n=47 Participants PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP	PPV + PEEP n=50 Participants PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90% PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)
Discomfort of the Preoxygenation Phase Self Reported by the Patient	0 millimeters Interval 0.0 to 18.0	8 millimeters Interval 0.0 to 20.0	0 millimeters Interval 0.0 to 10.0

Adverse Events

Spontaneous Breathing (SB)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Positive Pressure Ventilation (PPV)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PPV + PEEP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Spontaneous Breathing (SB) n=49 participants at risk preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%. End of preoxygenation FEO2=90%	Positive Pressure Ventilation (PPV) n=47 participants at risk PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90% PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP	PPV + PEEP n=50 participants at risk PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O. Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90% PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)
Nervous system disorders Anxiety	2.0% 1/49 • Number of events 1	0.00% 0/47	0.00% 0/50

Additional Information

Pr Jean-Luc Hanouz

CaenUH

Phone: 33 2 31 06 47 36

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place