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PANNIV: Using Positive Pressure Ventilation for Preoxygenation During Panendoscopy.

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Completed
CT.gov ID
NCT02167334
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
9
Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the aim of the study is to determine if Spontaneous Ventilation with Positive Pressure Ventilation (PPV) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation.

the hypothesis is PPV extends the residual functional capacity of lung so it provides more oxygen during apnea.

Condition or Disease Intervention/Treatment Phase
  • Device: positive pressure ventilation
  • Procedure: Oxygenation with simple breathing mask
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Non Invasive Ventilation (NIV) Versus Spontaneous Breathing for Preoxygenation During Ear, Nose, and Throat (ENT) Panendoscopy. A Controlled, Prospective, Randomized Study.
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: positive pressure ventilation

Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.

Device: positive pressure ventilation
Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.
Other Names:
  • non invasive ventilation (NIV)

    		•
    Active Comparator: Oxygenation with simple breathing mask

    spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.

    Procedure: Oxygenation with simple breathing mask
    Spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.

    Outcome Measures

    Primary Outcome Measures

    1. non hypoxemic apnea time [up to 5 minutes after stopping oxygenation]

      time the oxygen saturation is going down to 90% during apnea

    Secondary Outcome Measures

    1. surgical laryngoscopy frequency [up to 15 minutes after stopping oxygenation]

      number of stopped surgical laryngoscopy because of a low oxygen saturation under 90% with necessity to ventilate the patients during apnea

    2. preoxygenation time [up to 10 min after the start of oxygenation]

      time to reach expired oxygen fraction to 90%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patient going for scheduled panendoscopy under general anesthesia
    Exclusion Criteria:

    • BMI upper to 35 kg/m2

    • pregnancy

    • requirement of jet ventilation

    • tracheostomy

    • acute respiratory failure: pneumonia, pulmonary embolism

    • health insurance careless

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Amiens Amiens France 80000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire, Amiens

    Investigators

    • Principal Investigator: Osama ABOU ARAB, MD, CHU Amiens

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire, Amiens
    ClinicalTrials.gov Identifier:
    NCT02167334
    Other Study ID Numbers:
    • PI12-DR-DIMOV
    • 2012-A01053-40
    First Posted:
    Jun 19, 2014
    Last Update Posted:
    Apr 28, 2016
    Last Verified:
    Jun 1, 2014
    Keywords provided by Centre Hospitalier Universitaire, Amiens
    panendoscopy
    preoxygenation
    non invasive ventilation

    Study Results

    No Results Posted as of Apr 28, 2016