Skip to main content
OpenTrials
Completed

NCT Number: NCT01971892

Non Invasive Ventilation in Abdominal Postoperative Period

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgery Abdominal Injuries Acute Respiratory Failure Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Respiratory Trauma to the Abdomen Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 mask

Other

facial Venturi mask

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: NIVAS

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 29, 2013
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.