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High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01617252
Acronym
Optiflow
Enrollment
90
Registered
2012-06-12
Start date
2011-06-30
Completion date
2015-04-30
Last updated
2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemic Acute Respiratory Failure

Keywords

Cardiac surgery, Acute respiratory failure, High flow oxygen therapy

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.

Interventions

DEVICEOptiflow / 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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of PaO2/FiO2 ratioOne hour and 24 hoursThe 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

MeasureTime frameDescription
Scale of satisfaction completed by the patientat withdrawal of oxygen systemTo evaluate the tolerance of high flow oxygen therapy: satisfaction scale
Measure of pH, SatO2, PaO2, FiO22 daysTo evaluate hypoxia duration
Number of days of hospitalizationat day 28To evaluate the duration of hospitalization with the medical device
Measure of PCO2 and respiratory frequencyOne dayTo evaluate PCO2 and respiratory frequency at H+1 and J1
Possibility of patient transfer in conventional serviceat day 5To evaluate the reception in post reanimation if transfer under oxygen therapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026