Acute Respiratory FailureOXYPALNCT03673631
Oxygenation Methods and Non-invasive Ventilation in Patients With Acute Respiratory Failure and a do Not Intubate Order
An observational study of Acute Respiratory Failure and Cancer, run by Poitiers University Hospital at 1 site in France.
Trial summary
ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Cancer, Hematologic Malignancy
- What is being tested?
- NIV and NFHC-O2
- Type of treatment
- Medical device
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 7 Aug 2018to Jan 2020
- Phase
- Observational
- 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
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
Who may be able to join
- 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
Who cannot join
- refusal to participate
- legal protection
- pregnancy
- prophylactic treatment by VNI or HFNC-O2 after extubation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu de Poitiers
Poitiers, 86000
René ROBERT, MD,PhD, +335494443854, rene.robert@chu-poitiers.fr
Céline DELETAGE, CRA, +335494443854, celine.deletage@chu-poitiers.fr
About this study
Official title: 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
ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals
Read the 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
- Conditions
- Acute Respiratory Failure, Cancer, Hematologic Malignancy, Cardiac Insufficiency, Chronic Respiratory Insufficiency
- Being tested
- NIV, NFHC-O2
- Keywords
- non-invasive ventilation, nasal high flow humidified canula oxygenation, palliative, acute respiratory failure, withholding therapies, withdrawing therapies
- Medical subject headings
- Neoplasms, Hematologic Neoplasms, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIVDevice
NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)
NFHC-O2Device
NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min
| Study group | Role | What they receive |
|---|---|---|
| NFHC-O2 Group | NFHC-O2 therapy alone with gas flow at least 40L/min, Receives: Device: NFHC-O2 | |
| NIV/Standard-O2 Group | NIV sessions with at least 30% FiO2 and standard oxygen therapy Receives: Device: NIV | |
| NFHC-O2/NIV Group | combination of NIV sessions and NFHC-O2 therapy, Receives: Device: NIV; Device: NFHC-O2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at day 14
Survival at day 14 in patients weaned from NIV and or HNFC-O2
Measured: day 14
Secondary outcomes (6)
Clinical respiratory parameters evolution
respiratory rate improvement will be assessed by a decrease of respiratory rate below 20/min
Measured: day 1, day 2, day 3
Oxygenation parameters evolution
sPO2 (oxygen saturation) expressed in % improvement will be assessed by an increase above 92%
Measured: day 1, day 2, day 3
tolerance of technique of oxygenation
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
Measured: day 1, day 2, day 3
evolution of quality of life
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.
Measured: on admission and after 3 and 6 months after ICU stay
Acceptation of the non invasive technique
tolerance defined by the absence of refusal to continue the technique (NIV or HNFC O2) by the patient
Measured: day 14
mortality day 28
percentage of patients deceased at day 28 whatever the cause of death
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start7 Aug 2018
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
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 Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René ROBERT, MD,PhD, Study director, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673631
- Sponsor's protocol ID
- OXY-PAL
- Acronym
- OXYPAL
- Status last verified
- Aug 2018
- First submitted
- 2 Aug 2018
- Last updated
- 28 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Robert R, Frasca D, Badin J, Girault C, Guitton C, Djibre M, Beuret P, Reignier J, Benzekri-Llefevre D, Demiri S, Rahmani H, Argaud LA, I'her E, Ehrmann S, Lesieur O, Kuteifan K, Thouy F, Federici L, Thevenin D, Contou D, Terzi N, Nseir S, Thyrault M, Vinsonneau C, Audibert J, Masse J, Boyer A, Guidet B, Chelha R, Quenot JP, Piton G, Aissaoui N, Thille AW, Frat JP. Comparison of high-flow nasal oxygen therapy and non-invasive ventilation in ICU patients with acute respiratory failure and a do-not-intubate orders: a multicentre prospective study OXYPAL. BMJ Open. 2021 Feb 12;11(2):e045659. doi: 10.1136/bmjopen-2020-045659.
PubMed 33579774
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03673631
- Acronym / sponsor ID
- OXYPAL / OXY-PAL
- Conditions
- Acute Respiratory Failure, Cancer, Hematologic Malignancy, Cardiac Insufficiency, Chronic Respiratory Insufficiency
- Keywords
- non-invasive ventilation, nasal high flow humidified canula oxygenation, palliative, acute respiratory failure, withholding therapies, withdrawing therapies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 17 Sep 2018 (actual)
- 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.
ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NFHC-O2 Group | – | Device: NFHC-O2NFHC-O2 therapy alone with gas flow at least 40L/min, |
| NIV/Standard-O2 Group | – | Device: NIVNIV sessions with at least 30% FiO2 and standard oxygen therapy |
| NFHC-O2/NIV Group | – | Device: NIV, Device: NFHC-O2combination of NIV sessions and NFHC-O2 therapy, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- refusal to participate
- legal protection
- pregnancy
- prophylactic treatment by VNI or HFNC-O2 after extubation
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 |
|---|---|---|
| NIVNIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight) | Device | NFHC-O2/NIV Group, NIV/Standard-O2 Group |
| NFHC-O2NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min | Device | NFHC-O2 Group, NFHC-O2/NIV Group |
Primary outcome
Survival at day 14
Time frame: day 14
Survival at day 14 in patients weaned from NIV and or HNFC-O2
6 secondary outcomes
Clinical respiratory parameters evolution
Time frame: day 1, day 2, day 3
Oxygenation parameters evolution
Time frame: day 1, day 2, day 3
tolerance of technique of oxygenation
Time frame: day 1, day 2, day 3
evolution of quality of life
Time frame: on admission and after 3 and 6 months after ICU stay
Acceptation of the non invasive technique
Time frame: day 14
mortality day 28
Time frame: day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Derived from this study: PubMed 33579774Robert R, Frasca D, Badin J, Girault C, Guitton C, Djibre M, Beuret P, Reignier J, Benzekri-Llefevre D, Demiri S, Rahmani H, Argaud LA, I'her E, Ehrmann S, Lesieur O, Kuteifan K, Thouy F, Federici L, Thevenin D, Contou D, Terzi N, Nseir S, Thyrault M, Vinsonneau C, Audibert J, Masse J, Boyer A, Guidet B, Chelha R, Quenot JP, Piton G, Aissaoui N, Thille AW, Frat JP. Comparison of high-flow nasal oxygen therapy and non-invasive ventilation in ICU patients with acute respiratory failure and a do-not-intubate orders: a multicentre prospective study OXYPAL. BMJ Open. 2021 Feb 12;11(2):e045659. doi: 10.1136/bmjopen-2020-045659.
- Individual participant dataSharing planned: No
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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.
René ROBERT, MD,PhD study director
Poitiers University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Cancer, run by Poitiers University Hospital 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene ROBERT, MD,PhD (+335494443854, rene.robert@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival at day 14 (time frame: day 14). 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 NCT03673631, 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 28 Sep 2018.