Non Invasive Ventilation in Abdominal Postoperative Period

NCT01971892 | Completed DMC

• 1 other identifier: 9015
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Trauma to the Abdomen; Acute Respiratory Failure

Keywords

Abdominal surgery;; Postoperative complication;; Acute respiratory failure;; Hypoxemia;; Intubation;; Non-invasive ventilation

Outcome Measures

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.

  Endotracheal intubation.

  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

  one to two hours after inclusion in the protocol

• nosocomial infections within the 14 days and mortality

  At D-14 that means 14 days after initiation of treatment

• length of ICU

  From inclusion until the study until discharge or at 90 days maximal of ICU

Study Arms (2)

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%.

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%.

Other: Standard oxygen therapy with facial mask

Interventions

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

Non invasive ventilation (NIV)

Standard oxygen therapy with facial mask OTHER

facial Venturi mask

standard oxygen therapy with facial mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Department of Anesthesiology & Critical Care, St Eloi University Hospital

Montpellier, 34000, France

Location

Related Publications (2)

• 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.

  PMID: 39073580 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.

  PMID: 26975890 DERIVED

MeSH Terms

Conditions

Abdominal Injuries; Postoperative Complications; Hypoxia

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Samir Jaber, MD PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: October 29, 2013
• Study Start: May 1, 2013
• Primary Completion: September 16, 2014
• Study Completion: December 1, 2014
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (1)