Non Invasive Ventilation in Abdominal Postoperative Period (NIVAS)
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|ClinicalTrials.gov Identifier: NCT01971892|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Montpellier.
Recruitment status was: Active, not recruiting
First Posted : October 29, 2013
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Surgery Trauma to the Abdomen Acute Respiratory Failure||Other: Non Invasive ventilation (facial mask and NIV ventilator) Other: Standard oxygen therapy with facial mask||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: Non invasive ventilation (NIV)
Experimental arm = non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O) NIV will intermittently delivered to the patients for at least six hours (cumulative tme of all trials which lasted at least 30 min) during the first 24h after the initiation of treatment. Between each NIV period, the patient will received supplemental oxygen through facial mask to achieve an oxygen saturation level above 94%.
Other: Non Invasive ventilation (facial mask and NIV ventilator)
Non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O). NIW will be delivered through a facial mask with either NIV ventilator or ICU ventilator with NIV option
Active Comparator: standard oxygen therapy with facial mask
Patients assigned to standard medical therapy will received supplemental oxygen via a facial Venturi mask at a rate of up to 15 liters per minute with in order to maintain peripheral oxygen saturation above 94%.
Other: Standard oxygen therapy with facial mask
facial Venturi mask
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971892
|Department of Anesthesiology & Critical Care, St Eloi University Hospital|
|Montpellier, France, 34000|
|Principal Investigator:||Samir Jaber, MD PhD||University Hospital, Montpellier|