Preoxygenation With Positive Inspiratory Pressure During Induction of Anesthesia

NCT02313766 | Completed Results DMC

• 1 other identifier: 2005-39
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Time for Preoxygenationfrom Face Mask Positioning to FEO2=90%

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

  up to 5 min

Secondary Outcomes (2)

• Time Until SpO2=93%

  up to 10 min

• Discomfort of the Preoxygenation Phase Self Reported by the Patient

  Before PACU leaving

Study Arms (3)

spontaneous breathing (SB)

NO INTERVENTION

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)

EXPERIMENTAL

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%

Other: PPV : positive pressure ventilation

PPV + PEEP

EXPERIMENTAL

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%

Other: PEEP : PPV + PEEP

Interventions

PPV : positive pressure ventilation OTHER

Inspiratory pressure support ventilation (12 cmH2O) without PEEP

positive pressure ventilation (PPV)

PEEP : PPV + PEEP OTHER

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

PPV + PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Caen: lead

Related Publications (1)

• 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.

  PMID: 26225498 DERIVED

MeSH Terms

Interventions

Intermittent Positive-Pressure Ventilation; Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Pr Jean-Luc Hanouz
• Organization: CaenUH

hanouz-jl@chu-caen.fr

33 2 31 06 47 36

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 10, 2014
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: January 1, 2008
• Last Updated: April 14, 2016
• Results First Posted: January 7, 2015

Record last verified: 2016-03