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COMPLETED
NCT02389166
NA

Optiflow in Sequential Non-Invasive Ventilation

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

95

Start Date

2015-06-25

Completion Date

2019-03-05

Last Updated

2026-05-22

Healthy Volunteers

No

Interventions

DEVICE

Optiflow

Patients receive high flow oxygen delivery system, Optiflow, conventional clinical management and sequential used of NIV for a period of 36 hours at least. High flow oxygen nasal therapy (Optiflow) : The flow will be set at 40l/min to 60l/min The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a SaO2 between 94% and 98%.

DEVICE

Conventional oxygen therapy

Patients receive conventional oxygen therapy with high concentration mask, conventional clinical management, and sequential use of NIV Conventional oxygen therapy: The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a Arterial Oxygen Saturation (SaO2) between 94% and 98%.

Locations (8)

Service de réanimation - CH de la côte basque

Bayonne, Aquitaine, France

Service de réanimation médicale - CHU de Bordeaux

Bordeaux, Aquitaine, France

Service de Réanimation Polyvalente - CH de Libourne

Libourne, Aquitaine, France

Service de Réanimation - CH de Perigueux

Périgueux, Aquitiane, France

Service de Réanimation Polyvalente - CHU de Toulouse

Toulouse, Midi-pyrenees, France

Service de Réanimation Polyvalente - CH d'Agen

Agen, France

Réanimation polyvalente - CH d'Albi

Albi, France

Réanimation Polyvalente - CH de Mont de Marsan

Mont-de-Marsan, France