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Completed

NCT Number: NCT01617252

High Flow Nasal Oxygen Therapy for Hypoxemy After Cardiac Surgery

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.

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Key information

Conditions

Hypoxemic Acute Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nantes University Hospital

Nantes, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optiflow / Facial mask

Device

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

Primary outcomes

  1. Measure of PaO2/FiO2 ratio

    Time frame: 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 outcomes

  1. Scale of satisfaction completed by the patient

    Time frame: at withdrawal of oxygen system

    To evaluate the tolerance of high flow oxygen therapy: satisfaction scale

  2. Measure of pH, SatO2, PaO2, FiO2

    Time frame: 2 days

    To evaluate hypoxia duration

  3. Number of days of hospitalization

    Time frame: at day 28

    To evaluate the duration of hospitalization with the medical device

  4. Measure of PCO2 and respiratory frequency

    Time frame: One day

    To evaluate PCO2 and respiratory frequency at H+1 and J1

  5. Possibility of patient transfer in conventional service

    Time frame: at day 5

    To evaluate the reception in post reanimation if transfer under oxygen therapy

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: Optiflow

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2012
Registry last updated
Oct 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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