Optiflow in Sequential Non-Invasive Ventilation (VNI-HD)

University Hospital of Bordeaux

Status

Completed

Conditions

Respiratory Failure

Treatments

Device: Optiflow

Device: Conventional oxygen therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02389166

CHUBX 2013/28

Details and patient eligibility

About

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.

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.