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Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia

Randomized Controlled Trial on Preoxygenation Through Spontaneous Breathing or Non Invasive Positive Pressure Ventilation With and Without Positive End Expiratory Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02313766
Acronym
PREOX
Enrollment
150
Registered
2014-12-10
Start date
2006-10-31
Completion date
2008-01-31
Last updated
2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

Adults patients scheduled for elective surgery were randomly allocated to receive preoxygenation with spontaneous breathing, positive pressure ventilation (positive inspiratory pressure: 12 cmH2O) without PEEP, and with PEEP (positive inspiratory pressure: 12 cmH2O, PEEP: 6 cmH2O). Preoxygenation time was measured from face mask positioning to FEO2=90% (FEO2 : expired fraction of O2). After endotracheal tube placement the time until SpO2=93% (SpO2 : peripheral oxygen saturation) was measured during monitored apnoea. Patient's discomfort was recorded (visual analogue scale).

Detailed description

Inclusion criteria : age older 18 years, American Society of Anesthesiologists physical status I and II, and scheduled surgery with general anaesthesia and oro-tracheal intubation. Exclusion criteria : rapid sequence induction, anticipated difficult mask ventilation (2 or more factors among age \> 55 years, body mass index \> 26 kg m-2, beard, history of snoring, lack of teeth), anticipated difficult intubation (history of difficult intubation, Mallampati class 3 and 4, thyromental distance \< 60 mm, interincisor distance \< 35 mm, limited cervical spine movement), and refusal to participate to the study and to sign informed consent. Preoperative data recorded : age, height, weight, ASA physical status, and history of asthma, current smoking (ex-smokers were considered after a 3 month period without smoking), number of pack-years, sign inform consent The day of surgery, randomly allocation (random number table, block sizes of 15) to one of the 3 preoxygenation methods: spontaneous breathing, noninvasive positive inspiratory pressure ventilation (PPV) at 12 centimeters of water (cmH2O) without PEEP or with PEEP at 6 cmH2O (PEEP). Intravenous line placement and standard monitoring. Preoxygenated through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The circle breathing system was previously flushed with the O2 bypass during 30 s before mask placement. The inspired O2 concentration was set at 100%, the 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. Inspired and expired fraction of O2 and carbon dioxide (CO2) were continuously measured. End of the preoxygenation defined by FEO2=90%, intravenous anaesthesia was performed with propofol (2.5 mg kg-1 followed by a continuous administration at 8 mg kg-1 h-1 continuous infusion of propofol to target a bispectral index between 40 and 50), alfentanil 40 microg kg-1, and succinylcholine 1 mg kg-1. No face mask ventilation was provided before orotracheal intubation which was performed at the end of muscles fasciculation. The correct position of the tube (tracheal position above carina) was immediately checked using fiberoptic visualisation and was mandatory before atracurium 0.5 mg kg-1 administration. If tube misplacement occurred, the patient was excluded from the study in order to perform standard care. The time until SpO2 reached 93% was measured. The SpO2 and FEO2 were recorded every 10 s during the preoxygenation phase. The SpO2 was recorded every 10 s during the apnea phase. Just before leaving the post-anaesthesia care unit, the patient was asked to evaluate the preoxygenation method with the following questions: How do you evaluate the preoxygenation phase on the scale (cursor placed on a 100 mm visual analogue scale) between very comfortable (0 mm) to very uncomfortable (100 mm)? Do you want to have the same preoxygenation method for further anaesthesia (yes/no)? Primary endpoint : time for preoxygenation (average 180 s) calculated from face mask positioning to FEO2=90%. Secondary endpoints: duration of apnoea from tracheal tube positioning to SpO2 = 93% (average 5 to 10 min), and patient's comfort evaluated on a 0 to 100 mm visual analogue scale.

Interventions

OTHERPPV : positive pressure ventilation

Inspiratory pressure support ventilation (12 cmH2O) without PEEP

OTHERPEEP : PPV + PEEP

Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)

Sponsors

University Hospital, Caen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) physical status I and II * Scheduled surgery with general anaesthesia and oro-tracheal intubation

Exclusion criteria

* rapid sequence induction * anticipated difficult mask ventilation * anticipated difficult intubation * refusal to participate to the study and to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%up to 5 minTime measured form face mask positioning until FEO2 reached 90% on the gas monitor

Secondary

MeasureTime frameDescription
Time Until SpO2=93%up to 10 mintime until SpO2=93% after endotracheal tube placement has been confirmed
Discomfort of the Preoxygenation Phase Self Reported by the PatientBefore PACU leavingdiscomfort of the preoxygenation phase evaluated on a visual analogue scale (0 no discomfort - 100 maximal discomfort) just before PACU leaving

Participant flow

Recruitment details

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)

Pre-assignment details

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

Participants by arm

ArmCount
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%
49
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
47
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)
50
Total146

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event010
Overall StudyLost to Follow-up020
Overall Studysurgery cancelled100

Baseline characteristics

CharacteristicPositive Pressure Ventilation (PPV)PPV + PEEPSpontaneous Breathing (SB)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
5 Participants9 Participants7 Participants21 Participants
Age, Categorical
Between 18 and 65 years
42 Participants41 Participants42 Participants125 Participants
Age, Continuous40 years
STANDARD_DEVIATION 17
45 years
STANDARD_DEVIATION 20
45 years
STANDARD_DEVIATION 18
44 years
STANDARD_DEVIATION 19
Region of Enrollment
France
47 participants50 participants49 participants146 participants
Sex: Female, Male
Female
24 Participants20 Participants22 Participants66 Participants
Sex: Female, Male
Male
23 Participants30 Participants27 Participants80 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
1 / 490 / 470 / 50
serious
Total, serious adverse events
0 / 490 / 470 / 50

Outcome results

Primary

Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%

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

Time frame: up to 5 min

ArmMeasureValue (MEDIAN)
Spontaneous Breathing (SB)Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%190 seconds
Positive Pressure Ventilation (PPV)Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%153 seconds
PPV + PEEPTime for Preoxygenationfrom Face Mask Positioning to FEO2=90%140 seconds
Secondary

Discomfort of the Preoxygenation Phase Self Reported by the Patient

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

Time frame: Before PACU leaving

ArmMeasureValue (MEDIAN)
Spontaneous Breathing (SB)Discomfort of the Preoxygenation Phase Self Reported by the Patient0 millimeters
Positive Pressure Ventilation (PPV)Discomfort of the Preoxygenation Phase Self Reported by the Patient8 millimeters
PPV + PEEPDiscomfort of the Preoxygenation Phase Self Reported by the Patient0 millimeters
Secondary

Time Until SpO2=93%

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

Time frame: up to 10 min

ArmMeasureValue (MEDIAN)
Spontaneous Breathing (SB)Time Until SpO2=93%305 seconds
Positive Pressure Ventilation (PPV)Time Until SpO2=93%370 seconds
PPV + PEEPTime Until SpO2=93%345 seconds

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026