Respiratory InsufficiencyOPTIFLOWNCT01458444
BIPAP Vision Versus OPTIFLOW System Comparison in Acute Respiratory Failure After Cardio Thoracic Surgery
A study testing Non invasive ventilation (VNI) and Non invasive ventilation in people with Respiratory Insufficiency, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Non invasive ventilation (VNI) and Non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria:
- report PaO2/FiO2 <300
- Respiratory rate> 25 for at least 2 hours
- Getting involved accessory respiratory muscles
- paradoxical breathing Or
- In immediate after extubation, the patient will be eligible if present in the withdrawal test:
Show all 9Show fewer
- SaO2 <90% in 12 L of O2 during a trial of spontaneous ventilation tube on
- PaO2 <10 kPa at a FiO2 ≥ 50% during a VS trial + pressure support
- The presence of a risk factor: Obesity (BMI> 30), FEVG <40%, Failed extubation prior, stridor
Who cannot join
- Previous history of SAS
- Patient tracheotomy
- Comas non hypercapnic
- bradypnea
- Cardiac arrest
- Gastric Surgery recent
Show all 9Show fewer
- Restlessness, lack of cooperation
- Nausea, vomiting
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Chirurgical MarieLannelongue
Le Plessis-Robinson, Île-de-France Region, 92350
About this study
Official title: Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.
Read the detailed description
Main objective: to determine, if the initiation of OPTIFLOW™ system immediate after cardio/ thoracic surgery with acute respiratory failure or immediate after post extubation in patients at risk, is not less than the start a VNI per BIPAP Vision ®system. In terms of reintubation rates, refusal to continue the technique, or switch to another technique proposed.
Secondary objectives:
- To assess changes in the sensation of dyspnea
- To analyze the skin tolerance and the comfort in this population
- To analyze the evolution of hemodynamic and respiratory parameters
- To compare the number of bronchoscopy performed during the patient's stay in intensive care unit
- Assess the number of postoperative pneumonia and antibiotic consumption
- To determine whether the initiation of any treatment changes in the immediate postoperative length of stay in intensive care and comprehensive.
- Conditions
- Respiratory Insufficiency
- Being tested
- Non invasive ventilation (VNI), Non invasive ventilation
- Keywords
- Respiratory Insufficiency, Cardiothoracic Surgery, Ventilation system
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilation (VNI)Device
BIPAP® vision
Non invasive ventilationDevice
OPTIFLOW system
| Study group | Role | What they receive |
|---|---|---|
| BIPAP | Active comparator | Non invasive ventilation (VNI) by BIPAP® vision Receives: Device: Non invasive ventilation (VNI) |
| OPTIFLOW | Experimental | OPTIFLOW system Receives: Device: Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of the ventilation system
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown
Measured: One week
Secondary outcomes (6)
Sensation of dyspnea
Measured: one week
Skin tolerance and comfort
Measured: One week
Evolution of hemodynamic and respiratory parameters
Measured: one week
number of bronchoscopy performed during the patient's stay in Intensive Care Unit
Measured: one week
number of postoperative pneumonia and antibiotic use
Measured: one week
length of stay in intensive care
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital NOVO, Hopital Jean Minjoz, University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Hopital Louis Pradel
- Responsible party
- Sponsor
- Investigators
- François STEPHAN, MD, Principal investigator, CCML
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458444
- Sponsor's protocol ID
- SC11-007
- Other IDs
- 2011-A00125-36
- Acronym
- OPTIFLOW
- Status last verified
- Aug 2015
- First submitted
- 21 Oct 2011
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
PubMed 25980660
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Respiratory Failure After Cardio Thoracic Surgery: Non Invasive Ventilation (VNI) by BIPAP Vision Versus OPTIFLOW System, Comparison.
- ClinicalTrials.gov ID
- NCT01458444
- Acronym / sponsor ID
- OPTIFLOW / SC11-007
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory Insufficiency, Cardiothoracic Surgery, Ventilation system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Collaborators
- Hôpital NOVO, Hopital Jean Minjoz, University Hospital, Bordeaux, University Hospital, Clermont-Ferrand, Hopital Louis Pradel
- Study start
- May 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The OPTIFLOW ™ use is becoming more common in acute respiratory failure cases, but its place in relation to VNI (Bi-PAP mode) is not yet defined. OPTIFLOW ™ vs the VNI comparison of the use, in the immediate postoperative period, should lead to define the role of each technique and lead to a optimal rationalization of patients management with acute respiratory failure after surgery.
Detailed description
Main objective: to determine, if the initiation of OPTIFLOW™ system immediate after cardio/ thoracic surgery with acute respiratory failure or immediate after post extubation in patients at risk, is not less than the start a VNI per BIPAP Vision ®system. In terms of reintubation rates, refusal to continue the technique, or switch to another technique proposed.
Secondary objectives:
- To assess changes in the sensation of dyspnea
- To analyze the skin tolerance and the comfort in this population
- To analyze the evolution of hemodynamic and respiratory parameters
- To compare the number of bronchoscopy performed during the patient's stay in intensive care unit
- Assess the number of postoperative pneumonia and antibiotic consumption
- To determine whether the initiation of any treatment changes in the immediate postoperative length of stay in intensive care and comprehensive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIPAP | Active comparator | Device: Non invasive ventilation (VNI)Non invasive ventilation (VNI) by BIPAP® vision |
| OPTIFLOW | Experimental | Device: Non invasive ventilationOPTIFLOW system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients after cardiac/thoracic surgery with acute respiratory failure defined by the presence of the following criteria:
- In immediate after extubation, the patient will be eligible if present in the withdrawal test:
Key exclusion criteria (9 listed)
- Previous history of SAS
- Patient tracheotomy
- Comas non hypercapnic
- bradypnea
- Cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive ventilation (VNI)BIPAP® vision | Device | BIPAP |
| Non invasive ventilationOPTIFLOW system | Device | OPTIFLOW |
Primary outcome
Failure of the ventilation system
Time frame: One week
Failure defined by reintubation rate, refusal to continue the technique, or switch to an another technique proposed breakdown
6 secondary outcomes
Sensation of dyspnea
Time frame: one week
Skin tolerance and comfort
Time frame: One week
Evolution of hemodynamic and respiratory parameters
Time frame: one week
number of bronchoscopy performed during the patient's stay in Intensive Care Unit
Time frame: one week
number of postoperative pneumonia and antibiotic use
Time frame: one week
length of stay in intensive care
Time frame: one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Derived from this study: PubMed 25980660Stephan F, Barrucand B, Petit P, Rezaiguia-Delclaux S, Medard A, Delannoy B, Cosserant B, Flicoteaux G, Imbert A, Pilorge C, Berard L; BiPOP Study Group. High-Flow Nasal Oxygen vs Noninvasive Positive Airway Pressure in Hypoxemic Patients After Cardiothoracic Surgery: A Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2331-9. doi: 10.1001/jama.2015.5213.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François STEPHAN, MD principal investigator
CCML
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation (VNI) and Non invasive ventilation in people with Respiratory Insufficiency, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of the ventilation system (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.