SurgeryNIVASNCT01971892
Non Invasive Ventilation in Abdominal Postoperative Period
A study testing Non Invasive ventilation (facial mask and NIV ventilator) and Standard oxygen therapy with facial mask in people with Surgery and Trauma to the Abdomen, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Trauma to the Abdomen, Acute Respiratory Failure
- What is being tested?
- Non Invasive ventilation (facial mask and NIV ventilator) and Standard oxygen therapy with facial mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility :
- age of more than 18 years
- scheduled for elective or not elective abdominal surgery requiring laparotomy or laparoscopy and general anesthesia.
- acute respiratory failure occurring within the seven days of the surgery procedure which is defined as presence and persistence for at least 30 min and at least one of the two followings: 1) a respiratory rate of more than 30 breaths per minute and 2) clinical signs suggestive of respiratory muscle fatigue, increased work of breathing, or both, such as use of respiratory accessory muscles, paradoxical motion of the abdomen, or retraction of intercostal spaces
- hypoxemia defined by a PaO2 lower than 60 mmHg in ambient air or lower than 80 mmHg under 15 liters O2 or an arterial O2 saturation by pulse-oximetry (SpO2) lower than 90% (PaO2/FiO2< 200 mmHg).
Who cannot join
- Emergency procedure surgery (operation that must be performed as soon as possible and no longer than 12 hours after inclusion in the study)
- previous recruitment into another trial.
- Cardiopulmonary arrest
- Glasgow coma scale <8
- Absence of airway protective gag reflex
- Upper airway obstruction
Show all 9Show fewer
- Pregnancy.
- Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
- Chronic home non invasive ventilation
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Anesthesiology & Critical Care, St Eloi University Hospital
Montpellier, 34000
About this study
Official title: Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.
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.
Read the detailed description
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.
- Conditions
- Surgery, Trauma to the Abdomen, Acute Respiratory Failure
- Being tested
- Non Invasive ventilation (facial mask and NIV ventilator), Standard oxygen therapy with facial mask
- Keywords
- Abdominal surgery;, Postoperative complication;, Acute respiratory failure;, Hypoxemia;, Intubation;, Non-invasive ventilation
- Medical subject headings
- Abdominal Injuries, Postoperative Complications, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard oxygen therapy with facial maskOther
facial Venturi mask
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Other: Non Invasive ventilation (facial mask and NIV ventilator) |
| 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%. Receives: Other: Standard oxygen therapy with facial mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: primary end point will be evaluated within 7 days after the initiation of treatment.
Secondary outcomes (3)
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.
Measured: one to two hours after inclusion in the protocol
nosocomial infections within the 14 days and mortality
- Pulmonary infection
- Urinary infection
- Catherter related infection
- Bacteriemia and Mortality
Measured: 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).
Measured: From inclusion until the study until discharge or at 90 days maximal of ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startMay 2013
- Primary completion16 Sep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Jaber, MD PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971892
- Sponsor's protocol ID
- 9015
- Acronym
- NIVAS
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2013
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39073580Jaber 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.
PubMed 26975890
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01971892
- Acronym / sponsor ID
- NIVAS / 9015
- Conditions
- Surgery, Trauma to the Abdomen, Acute Respiratory Failure
- Keywords
- Abdominal surgery;, Postoperative complication;, Acute respiratory failure;, Hypoxemia;, Intubation;, Non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 16 Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive ventilation (NIV) | Experimental | Other: Non Invasive ventilation (facial mask and NIV ventilator)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 | Other: Standard oxygen therapy with facial maskPatients 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%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age of more than 18 years
- scheduled for elective or not elective abdominal surgery requiring laparotomy or laparoscopy and general anesthesia.
- acute respiratory failure occurring within the seven days of the surgery procedure which is defined as presence and persistence for at least 30 min and at least one of the two followings: 1) a respiratory rate of more than 30 breaths per minute and 2) clinical signs suggestive of respiratory muscle fatigue, increased work of breathing, or both, such as use of respiratory accessory muscles, paradoxical motion of the abdomen, or retraction of intercostal spaces
- hypoxemia defined by a PaO2 lower than 60 mmHg in ambient air or lower than 80 mmHg under 15 liters O2 or an arterial O2 saturation by pulse-oximetry (SpO2) lower than 90% (PaO2/FiO2< 200 mmHg).
Key exclusion criteria (9 listed)
- Emergency procedure surgery (operation that must be performed as soon as possible and no longer than 12 hours after inclusion in the study)
- previous recruitment into another trial.
- Cardiopulmonary arrest
- Glasgow coma scale <8
- Absence of airway protective gag reflex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Non invasive ventilation (NIV) |
| Standard oxygen therapy with facial maskfacial Venturi mask | Other | standard oxygen therapy with facial mask |
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.
3 secondary outcomes
Gas exchange after one to two hours after inclusion in the protocol
Time frame: one to two hours after inclusion in the protocol
nosocomial infections within the 14 days and mortality
Time frame: At D-14 that means 14 days after initiation of treatment
length of ICU
Time frame: From inclusion until the study until discharge or at 90 days maximal of ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 39073580Jaber 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.
- Derived from this study: PubMed 26975890Jaber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Jaber, MD PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Invasive ventilation (facial mask and NIV ventilator) and Standard oxygen therapy with facial mask in people with Surgery and Trauma to the Abdomen, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971892, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.