High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery (Optiflow)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Hypoxemic Acute Respiratory Failure

Treatments: Device: Optiflow / Facial mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01617252

BRD/10/09-H

Details and patient eligibility

About

The main objective of this study is to evaluate the gas exchange (ventilation-perfusion ratio) with the system Optiflow® compared to facial mask among patients having an acute respiratory failure after cardiac surgery.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with indication of coronary artery bypass
• Absence of preoperative respiratory failure
• Hypoxia after extubation defined as SpO2 < 96% with Venturi mask 50% 8L/min
• Age > 18 years
• Signed informed consent

Exclusion criteria

• Patients requiring an imminent intubation, in coma or respiratory exhaustion, in a state of shock or severe rhythm disorders
• Hemodynamic instability, low flow rate
• Pneumothorax or hemothorax
• Bleeding major, ischemic signs
• Ventricular arrhythmia
• Respiratory failure
• Non controlled hyperalgia
• Alteration of mental status
• Cardiac surgery patients in post-operative valve surgery associated with coronary artery bypass surgery or isolated valve surgery
• Pregnancy
• Major under guardianship

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Optiflow

Experimental group

Treatment:

Device: Optiflow / Facial mask

Facial mask

Experimental group

Treatment:

Device: Optiflow / Facial mask