High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Hypoxemic Acute Respiratory Failure Clinical Trial

— Optiflow  

Official title:

High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617252
• Other study ID #: BRD/10/09-H
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: October 2018
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxemic Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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