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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non invasive ventilation (NIV) | Experimental | 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%. |
|
| standard oxygen therapy with facial mask | Active Comparator | 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%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Invasive ventilation (facial mask and NIV ventilator) | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Endotracheal intubation. | primary end point will be evaluated within 7 days after the initiation of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Gas exchange after 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. | one to two hours after inclusion in the protocol |
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Inclusion Criteria:
Eligibility :
Inclusion :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samir Jaber, MD PhD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology & Critical Care, St Eloi University Hospital | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39073580 | Derived | Jaber S, Pensier J, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Verzilli D, Chanques G, De Jong A, Molinari N; NIVAS Study Group. Noninvasive ventilation on reintubation in patients with obesity and hypoxemic respiratory failure following abdominal surgery: a post hoc analysis of a randomized clinical trial. Intensive Care Med. 2024 Aug;50(8):1265-1274. doi: 10.1007/s00134-024-07522-4. Epub 2024 Jul 29. | |
| 26975890 |
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| ID | Term |
|---|---|
| D000007 | Abdominal Injuries |
| D011183 | Postoperative Complications |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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|
| Standard oxygen therapy with facial mask | Other | facial Venturi mask |
|
| nosocomial infections within the 14 days and mortality |
|
| At D-14 that means 14 days after initiation of treatment |
| length 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). | From inclusion until the study until discharge or at 90 days maximal of ICU |
| Derived |
| Jaber S, Lescot T, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Mimoz O, Hengy B, Sannini A, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Masseret E, Beaussier M, Verzilli D, De Jong A, Chanques G, Brochard L, Molinari N; NIVAS Study Group. Effect of Noninvasive Ventilation on Tracheal Reintubation Among Patients With Hypoxemic Respiratory Failure Following Abdominal Surgery: A Randomized Clinical Trial. JAMA. 2016 Apr 5;315(13):1345-53. doi: 10.1001/jama.2016.2706. |
| D012816 | Signs and Symptoms |