Clinical trial NCT02389166: Optiflow in Sequential Non-Invasive Ventilation
Official title: Randomized Clinical Trial Comparing High Flow Oxygen Delivery System (Optiflow) With Oxygen Therapy Under High-concentration Mask on Oxygenation of Patients Who Receive Sequential Non-Invasive Ventilation (NIV) Sessions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.

The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions

Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:

* control group with conventional clinical management, oxygen therapy and sequential used of NIV
* Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.

Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.


Eligibility criteria: Inclusion Criteria:

* Patient at least 18 years old
* Patients affiliated to or benefiting of the French social welfare system
* Patients with ARDS on previously healthy lung. Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio less than 200 mm Hg associated with the presence of lung infiltrates on chest radiograph
* Free and informed consent of patient
* Hospitalized in one of involved ICU

Exclusion Criteria:

* Existence of criteria for intubation.
* Refusal to participate in the study.
* Pregnancy
* Patient under guardianship or trusteeship
* Patients for whom a decision of non intubation has been decided.
* Patients who have received one or several NIV session for ARDS before hospital admission
* Home noninvasive ventilation
* Tracheostomy
* Hemodynamic instability
* Hypercapnia (PaCO2\>45 mm Hg).
* left ventricular failure (cardiogenic pulmonary acute edema).
* Ineffective coughing.
* Recent gastric or oesophageal surgery
* Severe ventricular rhythm disorder
* High digestive haemorrhage
* Lack of collaboration
* Pernicious vomiting
* Upper airway obstruction
* Severe sepsis.
* Undrained pneumothorax.

Primary outcomes:
measure: Average of oxygenation differences measured as the delta between PaO2/FiO2ratio at the end of the first ans second NIV session and at the end of the first and second oxygen therapy session.
timeFrame: 28 days
Secondary outcomes:
measure: comfort score dyspnea beetween the two NIV sessions
timeFrame: 28 days
measure: Incidence of serious adverse events between the two NIV sessions
timeFrame: 28 days
measure: Respiratory rate between the two NIV sessions
timeFrame: 28 days
measure: incidence of intubation during the NIV treatment of Acute respiratory distress syndrome (ARDS)
timeFrame: 28 days
measure: ICU mortality
timeFrame: 28 days
measure: 28 days survival
timeFrame: 28 days
measure: Hospital mortality
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
measure: duration of mechanical ventilation
timeFrame: 28 days
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Service de réanimation - CH de la côte basque
state: Aquitaine
city: Bordeaux
country: France
facility: Service de réanimation médicale - CHU de Bordeaux
state: Aquitaine
city: Libourne
country: France
facility: Service de Réanimation Polyvalente - CH de Libourne
state: Aquitaine
city: Perigueux
country: France
facility: Service de Réanimation - CH de Perigueux
state: Aquitiane
city: Toulouse
country: France
facility: Service de Réanimation Polyvalente - CHU de Toulouse
state: Midi-pyrenees
city: Agen
country: France
facility: Service de Réanimation Polyvalente - CH d'Agen
city: Albi
country: France
facility: Réanimation polyvalente - CH d'Albi
city: Mont de Marsan
country: France
facility: Réanimation Polyvalente - CH de Mont de Marsan
Study officials:
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, Docotor
role: STUDY_CHAIR
References: