search
Back to results

Non Invasive Ventilation in Abdominal Postoperative Period (NIVAS)

Primary Purpose

Surgery, Trauma to the Abdomen, Acute Respiratory Failure

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non Invasive ventilation (facial mask and NIV ventilator)
Standard oxygen therapy with facial mask
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery focused on measuring Abdominal surgery;, Postoperative complication;, Acute respiratory failure;, Hypoxemia;, Intubation;, Non-invasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eligibility :

  • age of more than 18 years
  • scheduled for elective or not elective abdominal surgery requiring laparotomy or laparoscopy and general anesthesia.

Inclusion :

  • 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).

Exclusion Criteria:

  • 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
  • Pregnancy.
  • Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach
  • Chronic home non invasive ventilation

Sites / Locations

  • Department of Anesthesiology & Critical Care, St Eloi University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non invasive ventilation (NIV)

standard oxygen therapy with facial mask

Arm Description

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%.

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%.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
nosocomial infections within the 14 days and mortality
Pulmonary infection Urinary infection Catherter related infection Bacteriemia and Mortality
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).

Full Information

First Posted
August 19, 2013
Last Updated
December 2, 2014
Sponsor
University Hospital, Montpellier
search

1. Study Identification

Unique Protocol Identification Number
NCT01971892
Brief Title
Non Invasive Ventilation in Abdominal Postoperative Period
Acronym
NIVAS
Official Title
Non Invasive Ventilation After Abdominal Surgery in Postoperative Acute Respiratory Failure: a Multicenter Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Trauma to the Abdomen, Acute Respiratory Failure
Keywords
Abdominal surgery;, Postoperative complication;, Acute respiratory failure;, Hypoxemia;, Intubation;, Non-invasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non invasive ventilation (NIV)
Arm Type
Experimental
Arm Description
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%.
Arm Title
standard oxygen therapy with facial mask
Arm Type
Active Comparator
Arm Description
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%.
Intervention Type
Other
Intervention Name(s)
Non Invasive ventilation (facial mask and NIV ventilator)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard oxygen therapy with facial mask
Intervention Description
facial Venturi mask
Primary Outcome Measure Information:
Title
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.
Description
Endotracheal intubation.
Time Frame
primary end point will be evaluated within 7 days after the initiation of treatment.
Secondary Outcome Measure Information:
Title
Gas exchange after one to two hours after inclusion in the protocol
Description
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.
Time Frame
one to two hours after inclusion in the protocol
Title
nosocomial infections within the 14 days and mortality
Description
Pulmonary infection Urinary infection Catherter related infection Bacteriemia and Mortality
Time Frame
At D-14 that means 14 days after initiation of treatment
Title
length of ICU
Description
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).
Time Frame
From inclusion until the study until discharge or at 90 days maximal of ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligibility : age of more than 18 years scheduled for elective or not elective abdominal surgery requiring laparotomy or laparoscopy and general anesthesia. Inclusion : 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). Exclusion Criteria: 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 Pregnancy. Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach Chronic home non invasive ventilation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Jaber, MD PhD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology & Critical Care, St Eloi University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26975890
Citation
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.
Results Reference
derived

Learn more about this trial

Non Invasive Ventilation in Abdominal Postoperative Period

We'll reach out to this number within 24 hrs