COVIDNCT04391140
Prone Positioning and High-flow Nasal Cannula in COVID-19 Induced ARDS
A study testing Prone position in people with COVID and ARDS, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, ARDS, Acute Respiratory Distress Syndrome
- What is being tested?
- Prone position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2020to Jun 2021
- 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
- COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected.
- Patient treated by nasal high flow.
- Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio <300 mmHg (or SpO2 / FiO2 equivalent).
- Informed consent.
- Beneficiary or affiliated to a social security scheme.
Who cannot join
- Indication of immediate tracheal intubation
- Significant acute progressive circulatory insufficiency
- Impaired alertness, confusion, restlessness
- Body mass index> 40 kg / m2
- Chest trauma or other contraindication to prone position
- Pneumothorax
- Vulnerable person: safeguard of justice
- Pregnant or lactating woman
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Oriol Roca, MD PhD, +34 93 274 62 09, oroca@vhebron.net
Marina García-de-Acilu, MD, +34 93 274 62 09, maringar@vhebron.net
About this study
Official title: Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.
Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.
Read more
Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.
Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.
Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
- Conditions
- COVID, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Corona Virus Infection
- Being tested
- Prone position
- Keywords
- PRONE POSITION, High flow nasal cannula
- Medical subject headings
- Respiratory Distress Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Combination of prone position and HFNC Receives: Other: Prone position |
| Control | No intervention | Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic failure death or intubation
Therapeutic failure: death or intubation
Measured: 28 days within randomization
Secondary outcomes (2)
Feasibility and safety of prone position in HFNC patients
- Comfort measurement using a visual-analog scale.
- Presence of complications related with prone position and the use of high-flow nasal cannula:
- Skin ulcers.
- Intravascular lines displacement
- HFNC related events (hot air feeling, nasal lesions)
Measured: 28 days within randomization
Efficacy of prone position in HFNC patients
- Evolution of the oxygenation (SpO2/FiO2) in prone position.
- Efficacy
- Length of HFNC therapy
- Length of ICU stay
- Length of mechanical ventilation (in those who require intubation)
- ICU and hospital mortality
Measured: 28 days within randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start13 May 2020
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391140
- Sponsor's protocol ID
- PR(AG)198/2020
- Status last verified
- May 2020
- First submitted
- 10 May 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared to perform a meta-trial including other studies that assess the effectiveness of prone position in COVID-19 patients supported with nasal high flow. No patient identifying data will be transferred to the data repository. The data set will use pseudoanonymised data. The consent process for the study will highlight that this is a meta-trial and that both aggregated and individual data without personal identifying features will be used to formulate the results from the study. Local regulation for the management of patient data needs to be adhered to as part of agreement for involvement in the study. Data will be shared during the study at two points, Time 1 An interim analysis at 200 patients in which aggregated outcome data for the primary outcome and severe adverse effects will be analyzed Time 2 Final analysis outlining salient clinical feature of patients for each group, outcomes
Publications
Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
PubMed 34425070Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
PubMed 33177145
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Prone Positioning Combined With High-flow Nasal Cannula for Patients With COVID-19 Induced ARDS
- ClinicalTrials.gov ID
- NCT04391140
- Acronym / sponsor ID
- PR(AG)198/2020
- Conditions
- COVID, ARDS, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Corona Virus Infection
- Keywords
- PRONE POSITION, High flow nasal cannula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 18 May 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.
Prone position (PP) has been proved to be effective in severe ARDS patients. On the other hand, High flow nasal cannula (HFNC) may prevent intubation in hypoxemic Acute respiratory failure (ARF) patients.
Our hypothesis is that the combination of PP and HFNC in patients with COVID19 induced ARDS may decrease the need of mechanical ventilation.
Primary outcome: Therapeutic failure within 28 days of randomization (death or intubation). Secondary outcomes: to analyze PP feasibility and safety in HFNC patients and to analyze effectiveness in terms of oxygenation.
Methods: multicentric randomized study including patients with COVID19 induced ARDS supported with HFNC. Experimental group will received HFNC and PP whereas observation group will received standard care.
Optimization of non-invasive respiratory management of COVID19 induced ARDS patients may decrease the need of invasive mechanical ventilation and subsequently ICU and hospital length of stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Prone positionCombination of prone position and HFNC |
| Control | No intervention | –Standard care: HFNC set for a SpO2 90-95% if unless indication for intubation is present. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COVID-19 pneumonia according to the diagnostic criteria in effect at the time of inclusion or very strongly suspected.
- Patient treated by nasal high flow.
- Moderate or severe ARDS: bilateral radiological opacities not explained entirely by effusions, atelectasis or nodules; acute hypoxemia with worsening within the 7 previous days, not entirely explained by left ventricular failure; PaO2 / FiO2 ratio <300 mmHg (or SpO2 / FiO2 equivalent).
- Informed consent.
- Beneficiary or affiliated to a social security scheme.
Key exclusion criteria (8 listed)
- Indication of immediate tracheal intubation
- Significant acute progressive circulatory insufficiency
- Impaired alertness, confusion, restlessness
- Body mass index> 40 kg / m2
- Chest trauma or other contraindication to prone position
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 positionHFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily. | Other | Experimental |
Primary outcome
Therapeutic failure death or intubation
Time frame: 28 days within randomization
Therapeutic failure: death or intubation
2 secondary outcomes
Feasibility and safety of prone position in HFNC patients
Time frame: 28 days within randomization
Efficacy of prone position in HFNC patients
Time frame: 28 days within randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Derived from this study: PubMed 34425070Ehrmann S, Li J, Ibarra-Estrada M, Perez Y, Pavlov I, McNicholas B, Roca O, Mirza S, Vines D, Garcia-Salcido R, Aguirre-Avalos G, Trump MW, Nay MA, Dellamonica J, Nseir S, Mogri I, Cosgrave D, Jayaraman D, Masclans JR, Laffey JG, Tavernier E; Awake Prone Positioning Meta-Trial Group. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial. Lancet Respir Med. 2021 Dec;9(12):1387-1395. doi: 10.1016/S2213-2600(21)00356-8. Epub 2021 Aug 20.
- Derived from this study: PubMed 33177145Tavernier E, McNicholas B, Pavlov I, Roca O, Perez Y, Laffey J, Mirza S, Cosgrave D, Vines D, Frat JP, Ehrmann S, Li J. Awake prone positioning of hypoxaemic patients with COVID-19: protocol for a randomised controlled open-label superiority meta-trial. BMJ Open. 2020 Nov 11;10(11):e041520. doi: 10.1136/bmjopen-2020-041520.
- Individual participant dataSharing planned: Yes. Data will be shared to perform a meta-trial including other studies that assess the effectiveness of prone position in COVID-19 patients supported with nasal high flow. No patient identifying data will be transferred to the data repository. The data set will use pseudoanonymised data. The consent process for the study will highlight that this is a meta-trial and that both aggregated and individual data without personal identifying features will be used to formulate the results from the study. Local regulation for the management of patient data needs to be adhered to as part of agreement for involvement in the study. Data will be shared during the study at two points, Time 1 An interim analysis at 200 patients in which aggregated outcome data for the primary outcome and severe adverse effects will be analyzed Time 2 Final analysis outlining salient clinical feature of patients for each group, outcomes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position in people with COVID and ARDS, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 8 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 18 Aug 2020. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic failure death or intubation (time frame: 28 days within randomization). 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 NCT04391140, which also lists 2 linked publications.
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 18 Aug 2020.