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

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemic Acute Respiratory Failure
• Intervention / Treatment: Device: Optiflow / Facial mask

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optiflow	Device: Optiflow / Facial mask; J0: randomization (Optiflow® or facial mask), lung X-ray, kinesiotherapy H0 : clinical examination, blood gas, respiratory frequency H1 : clinical examination, blood gas, respiratory frequency H6 : clinical examination, blood gas J1: clinical examination, blood gas, respiratory frequency, lung X-ray, diaphragmatic echography, kinesiotherapy J2: clinical examination, blood gas, lung X-ray, kinesiotherapy Follow-up (until withdrawal of Optiflow or facial mask): clinical examination, blood gas, lung X-ray, kinesiotherapy
Experimental: Facial mask	Device: Optiflow / Facial mask; J0: randomization (Optiflow® or facial mask), lung X-ray, kinesiotherapy H0 : clinical examination, blood gas, respiratory frequency H1 : clinical examination, blood gas, respiratory frequency H6 : clinical examination, blood gas J1: clinical examination, blood gas, respiratory frequency, lung X-ray, diaphragmatic echography, kinesiotherapy J2: clinical examination, blood gas, lung X-ray, kinesiotherapy Follow-up (until withdrawal of Optiflow or facial mask): clinical examination, blood gas, lung X-ray, kinesiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of PaO2/FiO2 ratio	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.	One hour and 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 8, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac surgery; Acute respiratory failure; High flow oxygen therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: BRD/10/09-H