High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Not Applicable

Completed

• Conditions: Hypoxemic Acute Respiratory Failure
• Interventions: Device: Optiflow / Facial mask

• Registration Number: NCT01617252
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-06-08
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facial mask	Optiflow / Facial mask	-
Optiflow	Optiflow / Facial mask	-

Primary Outcome Measures

Name	Time	Method
Measure of PaO2/FiO2 ratio	One hour and 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Measure of pH, SatO2, PaO2, FiO2	2 days	To evaluate hypoxia duration
Scale of satisfaction completed by the patient	at withdrawal of oxygen system	To evaluate the tolerance of high flow oxygen therapy: satisfaction scale
Measure of PCO2 and respiratory frequency	One day	To evaluate PCO2 and respiratory frequency at H+1 and J1
Possibility of patient transfer in conventional service	at day 5	To evaluate the reception in post reanimation if transfer under oxygen therapy
Number of days of hospitalization	at day 28	To evaluate the duration of hospitalization with the medical device

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France