- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03673631
Oxygenation Methods and Non-invasive Ventilation in Patients With Acute Respiratory Failure and a do Not Intubate Order (OXYPAL)
Evaluation of Oxygenation Methods and Non-invasive Ventilatory Support in Patients With Acute Respiratory Failure for Whom a Do-not Intubate Order Was Taken: Prospective Observational Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Observational prospective multicenter study Primary outcome: To analyze the efficacy and tolerance of NIV and HFNC in patients admitted to intensive care unit, or intermediate catre unit for acute respiratory insufficiency for whom a a do-not intubate order decision was taken upon admission or after extubation if the patient initially received mechanical ventilation.
Secondary outcomes: To analyze the efficacy and tolerance of NIV and HFNC according to the following reason for ICU admission: chronic obstructive pneumopathy decompensated COPD, severe heart failure, evolutive cancer or hematologic malignancy; to analyze tolerance and acceptability of different techniques; to analyze the duration of the oxygenation methods use; to analyze the modalities of eventual withdrawing life support therapies and the associated sedative and opioid treatments; to analyze the satisfaction for the use of the non invasive technique by the relatives and the caregivers; to analyze mortality at D28 and D90 and quality of life at 3 and 6 months in surviving patients
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: René ROBERT, MD,PhD
- Phone Number: +335494443854
- Email: rene.robert@chu-poitiers.fr
Study Contact Backup
- Name: Céline DELETAGE, CRA
- Phone Number: +335494443854
- Email: celine.deletage@chu-poitiers.fr
Study Locations
-
-
-
Poitiers, France, 86000
- Recruiting
- CHU de Poitiers
-
Contact:
- René ROBERT, MD,PhD
- Phone Number: +335494443854
- Email: rene.robert@chu-poitiers.fr
-
Contact:
- Céline DELETAGE, CRA
- Phone Number: +335494443854
- Email: celine.deletage@chu-poitiers.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- patient admitted in ICU or intermediate care with decision of a do-not intubate order on admission or after extubation (for patients receiving invasive mechanical ventilation)
- with acute respiratory failure criteria (respiratory rate >25/min; contraction of accessory respiratory muscles or hypoxemia requiering > 3L/min O2 to obtain SpO2 >92%)
- and having indication for NIV or HFNC-O2
Description
Inclusion Criteria:
- acute respiratory failure defined by respiratory rate>25/min and or hypoxemia (sPO2 <92% with O2 >3l/min)
- admission in ICU or intermediate care unit
- decision to not intubate the patient or to not re-intubate the patient
- indication to NIV or HFNC-O2
- French social security affiliation
Exclusion Criteria:
- refusal to participate
- legal protection
- pregnancy
- prophylactic treatment by VNI or HFNC-O2 after extubation
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NFHC-O2 Group
NFHC-O2 therapy alone with gas flow at least 40L/min,
|
NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min
|
NIV/Standard-O2 Group
NIV sessions with at least 30% FiO2 and standard oxygen therapy
|
NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)
|
NFHC-O2/NIV Group
combination of NIV sessions and NFHC-O2 therapy,
|
NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min
NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival at day 14
Time Frame: day 14
|
Survival at day 14 in patients weaned from NIV and or HNFC-O2
|
day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical respiratory parameters evolution
Time Frame: day 1, day 2, day 3
|
respiratory rate improvement will be assessed by a decrease of respiratory rate below 20/min
|
day 1, day 2, day 3
|
Oxygenation parameters evolution
Time Frame: day 1, day 2, day 3
|
sPO2 (oxygen saturation) expressed in % improvement will be assessed by an increase above 92%
|
day 1, day 2, day 3
|
tolerance of technique of oxygenation
Time Frame: day 1, day 2, day 3
|
tolerance will be assessed by comfort visual analogic scale from 1 worse tolerance to 10 very good tolerance; improvement defined as a 20% decrease of the value
|
day 1, day 2, day 3
|
evolution of quality of life
Time Frame: on admission and after 3 and 6 months after ICU stay
|
quality of life will be measured by the EuroQuality of life 5D score (EQ5D) recording 5 subscore (mobility, autonomy, ability to perform current activities, pain, anxety/depression); the value of each is from 1 to 3 points; total score is the sum of the 5 subscores with a minimal score of 5 and a maximal score of 15.
The baseline score will be recorded after admission in the ICU and reflects the patient's quality of life just before his or her admission.
After 3 and 6 months, a higher value of the score will represent a worse outcome.
|
on admission and after 3 and 6 months after ICU stay
|
Acceptation of the non invasive technique
Time Frame: day 14
|
tolerance defined by the absence of refusal to continue the technique (NIV or HNFC O2) by the patient
|
day 14
|
mortality day 28
Time Frame: day 28
|
percentage of patients deceased at day 28 whatever the cause of death
|
day 28
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: René ROBERT, MD,PhD, Poitiers university hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OXY-PAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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