Clinical Trial: Non Invasive Ventilation in Abdominal Postoperative Period

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.

Brief Summary: Acute respiratory failure may occur early in the postoperative course, requiring endotracheal intubation and mechanical ventilation in selected patients, thus increasing morbidity and mortality and prolonging intensive care unit (ICU) and hospital stay.We will perform a multicenter, prospective, randomized clinical trial to compare the efficacy of non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) with standard oxygen therapy in the treatment of postoperative acute respiratory failure. We also set out to examine the hypothesis that early application of NIV may prevent intubation and mechanical ventilation in patients who develop acute respiratory failure after abdominal surgery.

Detailed Summary: The Non-Invasive Ventilation After Surgery (NIVAS) is an investigator-initiated, multi-center, stratified, two-arm parallel-group trial with a computer-generated allocation sequence and electronic system based randomization. The study protocol and statistical analysis plan were approved for all centers by a central Ethics Committee (France) according to French law.The NIVAS study is conducted in accordance with the declaration of Helsinki and was registered on August 2013.All centers have a long experience with NIV (more than 10 years of NIV use for ARF, and more than 5 years of NIV use for ARF following abdominal surgery). Randomization will stratified by department, age (less or more 60 years), site of surgery (upper or lower abdominal) and according to the presence or absence of postoperative epidural analgesia as this may influence outcomes. Treatment assignments will concealed from patients, research staff, the statistician, and the data monitoring and safety committee.
Sponsor: University Hospital, Montpellier

Current Primary Outcome: The primary end point for the comparison between noninvasive ventilation (NIV) and standard oxygen therapy will be the tracheal intubation within 7 days after the initiation of treatment. [ Time Frame: primary end point will be evaluated within 7 days after the initiation of treatment. ]

Endotracheal intubation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gas exchange after one to two hours after inclusion in the protocol [ Time Frame: one to two hours after inclusion in the protocol ]
    Gas exchange will be obtain from arterial blood gases from an arterial line (radial or femoral). Judgement criteria for gas exchange will be oxygenation evaluated by PaO2/FiO2 ratio and PaCO2.
  • nosocomial infections within the 14 days and mortality [ Time Frame: At D-14 that means 14 days after initiation of treatment ]
    • Pulmonary infection
    • Urinary infection
    • Catherter related infection
    • Bacteriemia and Mortality
  • length of ICU [ Time Frame: From inclusion until the study until discharge or at 90 days maximal of ICU ]
    Total ICU stay, i.e, from ICU admission until discharge will be also evaluated at a maximum of 90 days (which is the end of the follow up of the study).


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: August 19, 2013
Date Started: May 2013
Date Completion: December 2014
Last Updated: December 2, 2014
Last Verified: December 2014