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AnesthesiaPREOXNCT02313766

Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia

A study testing PPV : positive pressure ventilation and PEEP : PPV + PEEP in people with Anesthesia, run by University Hospital, Caen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia
What is being tested?
PPV : positive pressure ventilation and PEEP : PPV + PEEP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
Oct 2006to Jan 2008
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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).

Read the 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.

Conditions
Anesthesia
Being tested
PPV : positive pressure ventilation, PEEP : PPV + PEEP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PPV : positive pressure ventilationOther

    Inspiratory pressure support ventilation (12 cmH2O) without PEEP

  • PEEP : PPV + PEEPOther

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

Study groups in NCT02313766
Study groupRoleWhat they receive
spontaneous breathing (SB)No interventionpreoxygenation 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)ExperimentalPPV : 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%
Receives: Other: PPV : positive pressure ventilation
PPV + PEEPExperimentalPEEP : 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%
Receives: Other: PEEP : PPV + PEEP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%

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

    Measured: up to 5 min

Secondary outcomes (2)
  1. Time Until SpO2=93%

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

    Measured: up to 10 min

  2. 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

    Measured: Before PACU leaving

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2014 (estimated)
  2. Study startOct 2006
  3. Primary completionOct 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313766
Sponsor's protocol ID
2005-39
Acronym
PREOX
Status last verified
Mar 2016
First submitted
1 Dec 2014
Last updated
14 Apr 2016
Data monitoring committee
Yes

Publications

  • Hanouz JL, Lammens S, Tasle M, Lesage A, Gerard JL, Plaud B. Preoxygenation by spontaneous breathing or noninvasive positive pressure ventilation with and without positive end-expiratory pressure: A randomised controlled trial. Eur J Anaesthesiol. 2015 Dec;32(12):881-7. doi: 10.1097/EJA.0000000000000297.

    PubMed 26225498

Questions about this trial

What is this clinical trial studying?

A study testing PPV : positive pressure ventilation and PEEP : PPV + PEEP in people with Anesthesia, run by University Hospital, Caen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time for Preoxygenationfrom Face Mask Positioning to FEO2=90% (time frame: up to 5 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.

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