NCT01617252

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

October 4, 2018

Status Verified

October 1, 2018

Enrollment Period

3.8 years

First QC Date

June 8, 2012

Last Update Submit

October 2, 2018

Conditions

Hypoxemic Acute Respiratory Failure

Keywords

Cardiac surgeryAcute respiratory failureHigh flow oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Scale of satisfaction completed by the patient

    at withdrawal of oxygen system

  • Measure of pH, SatO2, PaO2, FiO2

    2 days

  • Number of days of hospitalization

    at day 28

  • Measure of PCO2 and respiratory frequency

    One day

  • Possibility of patient transfer in conventional service

    at day 5

Study Arms (2)

Optiflow

EXPERIMENTAL
Device: Optiflow / Facial mask

Facial mask

EXPERIMENTAL
Device: Optiflow / Facial mask

Interventions

Optiflow / Facial maskDEVICE

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

Facial maskOptiflow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

June 12, 2012

Study Start

June 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 4, 2018

Record last verified: 2018-10

Locations

FR(1)