Non Invasive Ventilation in Abdominal Postoperative Period

Surgery Clinical Trial

— NIVAS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01971892
• Other study ID #: UF 9015
• Status: Active, not recruiting
• Phase: N/A
• First received: August 19, 2013
• Last updated: December 2, 2014
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Injuries
• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency
• Surgery
• Trauma to the Abdomen

Intervention

Other:
• 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
• Standard oxygen therapy with facial mask
facial Venturi mask

Locations

Country	Name	City	State
France	Department of Anesthesiology & Critical Care, St Eloi University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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	Yes
Secondary	nosocomial infections within the 14 days and mortality	Pulmonary infection; Urinary infection; Catherter related infection; Bacteriemia and Mortality	At D-14 that means 14 days after initiation of treatment	Yes
Secondary	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	Yes