Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory FailureProPNIVFlowNCT04306107
Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy
A study testing Prone position during non-invasive respiratory support in people with Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure, run by Hospital General Universitario Morales Meseguer.
Trial summary
The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
- What is being tested?
- Prone position during non-invasive respiratory support
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 May 2022
- 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
- Adult patients with:
- ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)
Who cannot join
- General NIV or HFNC contraindications
- Immediate need for IOT
- Prone position intolerance
- Patients refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.
Read the detailed description
Inclusion Criteria:
Adult patients with:
- ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)
Exclusion Criteria
- General NIV or HFNC contraindications
- Immediate need for IOT
- Prone position intolerance
- Patients refusal to participate
Interventions:
- Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU)
- Nurse surveilance: at least every 15 minutes
Outcomes:
- Need for IOT
- Effects on the measurements specified above (particularly PaO2/FiO2)
- Conditions
- Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
- Being tested
- Prone position during non-invasive respiratory support
- Keywords
- Noninvasive ventilation, High-flow nasal oxygen therapy, Prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone position during non-invasive respiratory supportDevice
Also called HFNC and NIV application with patient on prone position
HFNC and NIV application with patient on prone position
| Study group | Role | What they receive |
|---|---|---|
| NIV with prone position | Experimental | Use of prone position during NIV Receives: Device: Prone position during non-invasive respiratory support |
| NIV (conventional) | Placebo comparator | NIV on conventional position Receives: Device: Prone position during non-invasive respiratory support |
| HFNC on prone position | Experimental | Prone position during HFNC Receives: Device: Prone position during non-invasive respiratory support |
| HFNC (conventional) | Placebo comparator | HFNC on conventional position Receives: Device: Prone position during non-invasive respiratory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oro-tracheal entubation
Oro-tracheal entubation avoidance
Measured: 1 month
Secondary outcomes (1)
PaO2/FiO2
Effect of prone position on PaO2/FiO2
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Sep 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory FailureStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Morales Meseguer
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Filipe Martins de Matos Navarro Guia, Hospital General Universitario Morales Meseguer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306107
- Sponsor's protocol ID
- 10-03-2020
- Other IDs
- 10-03-2020 2
- Acronym
- ProPNIVFlow
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy
- ClinicalTrials.gov ID
- NCT04306107
- Acronym / sponsor ID
- ProPNIVFlow / 10-03-2020
- Conditions
- Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
- Keywords
- Noninvasive ventilation, High-flow nasal oxygen therapy, Prone position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario Morales MeseguerUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 12 Mar 2020 (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.
The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.
Detailed description
Inclusion Criteria:
Adult patients with:
- ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)
Exclusion Criteria
- General NIV or HFNC contraindications
- Immediate need for IOT
- Prone position intolerance
- Patients refusal to participate
Interventions:
- Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU)
- Nurse surveilance: at least every 15 minutes
Outcomes:
- Need for IOT
- Effects on the measurements specified above (particularly PaO2/FiO2)
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NIV with prone position | Experimental | Device: Prone position during non-invasive respiratory supportUse of prone position during NIV |
| NIV (conventional) | Placebo comparator | Device: Prone position during non-invasive respiratory supportNIV on conventional position |
| HFNC on prone position | Experimental | Device: Prone position during non-invasive respiratory supportProne position during HFNC |
| HFNC (conventional) | Placebo comparator | Device: Prone position during non-invasive respiratory supportHFNC on conventional position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with:
Key exclusion criteria (4 listed)
- General NIV or HFNC contraindications
- Immediate need for IOT
- Prone position intolerance
- Patients refusal to participate
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 |
|---|---|---|
| Prone position during non-invasive respiratory supportAlso: HFNC and NIV application with patient on prone positionHFNC and NIV application with patient on prone position | Device | HFNC (conventional), HFNC on prone position, NIV (conventional), NIV with prone position |
Primary outcome
Oro-tracheal entubation
Time frame: 1 month
Oro-tracheal entubation avoidance
1 secondary outcome
PaO2/FiO2
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position during non-invasive respiratory support in people with Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure, run by Hospital General Universitario Morales Meseguer.
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 2 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 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Miguel Guia, MD (00351915774975 ext. 00351915774975, miguelguia7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oro-tracheal entubation (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2021.