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ARDS, HumanAPPROVE-CARENCT04347941

Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE

A study testing Prone Positioning in people with ARDS, Human and Mechanical Ventilation Complication, run by University College Hospital Galway at 1 site in Ireland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prone Positioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteIreland
Study dates
11 Jul 2020to 26 Jan 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Suspected or confirmed COVID19 infection
  • Bilateral Infiltrates on CXR
  • SpO2 <94% on FiO2 40% by either venturi facemask or high flow nasal cannula
  • RR <40
  • Written informed consent

Who cannot join

  • Age <18
  • Uncooperative or likely to be unable to lie on abdomen for 16 hours
  • Receiving comfort care only
  • Multi-organ failure
  • RR>40
  • Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, pregnancy >20/40 gestation, severe brain injury).

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Galway University Hospital

    Galway

Other trials in Ireland

About this study

Prone positioning (PP) is an effective first-line intervention to treat moderate-severe acute respiratory distress syndrome (ARDS) patients receiving invasive mechanical ventilation, as it improves gas exchanges and lowers mortality.The use of PP in awake self-ventilating patients with (e.g. COVID-19 induced) ARDS could improve gas exchange and reduce the need for invasive mechanical ventilation, but has not been studied outside of case series.The investigators will conduct a randomized controlled study of patients with COVID-19 induced respiratory failure to determine if prone positioning reduces the need for mechanical ventilation compared to standard management.

Read the detailed description

Prone positioning (PP) is an adjunctive therapy used that has been proven to save lives in sedated patients with confirmed moderate-severe acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (MV). PP involves placing patients in the prone, i.e. face down position for time periods of up to 16 hours per day. PP promotes lung homogeneity, improves gas exchange and respiratory mechanics permitting reduction of ventilation intensity, and reducing ventilator-induced lung injury (VILI).

Maintaining self-ventilation is associated with increased aeration of dependent lung regions, less need for sedation, improved cardiac filling and removes the risk of VILI, and so is an important therapeutic goal in hypoxic patients. The use of PP in awake self-ventilating patients with COVID-19 induced acute hypoxic respiratory failure (AHRF) and/or ARDS could improve gas exchange and reduce the need for invasive MV, but has not been studied outside of case series.

However, an increase in oxygenation does not necessarily reduce the risk of invasive MV. PP has significant attached risks such as causing pressure sores in patients, PP is uncomfortable for some patients, it increases nursing workload, and if ineffective could hinder the delivery of other (effective) medical care. Hence there is a need to determine if PP of awake patients is effective in reducing the need for invasive MV. This multi-centre, open label, randomized controlled study of COVID-19 induced AHRF/ARDS will determine if PP reduces the need for mechanical ventilation.

Being tested
Prone Positioning, Standard of care.
Medical subject headings
Respiratory Distress Syndrome, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prone PositioningProcedure or surgery

    Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula

  • Standard of care.Procedure or surgery

    Standard of care. Prone positioning may be administered as a rescue therapy

Study groups in NCT04347941
Study groupRoleWhat they receive
Prone PositioningExperimentalIntervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals
Receives: Procedure: Prone Positioning
Standard CareActive comparatorControl patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.
Receives: Procedure: Standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure.

    A measure of effect of awake prone positioning in patients with confirmed or suspected COVID-19 acute hypoxemic respiratory failure undergoing supplemental oxygen via high flow nasal cannular oxygen on reducing requirement for invasive mechanical ventilation or death. Outcome measure is calculated as a count of the number of patients who went onto require invasive mechanical ventilation or died up to 28 days post randomization.

    Measured: Up to 28 days post randomisation

Secondary outcomes (9)

  1. Length of Time Tolerating Prone Positioning

    description of duration of prone positioning in hours per day from day 0 to day 14 in trial

    Measured: Daily during intervention up to 14 days post randomisation

  2. PaO2/FiO2 Ratio Measured Before Prone Positioning

    Measure of change in oxygenation before intervention in the patients assigned to awake prone positioning

    Measured: Immediately before intervention

  3. PaO2/FiO2 Ratio After 1 Hours of Prone Positioning

    Measure of change in oxygenation following patients being placed in the prone position for 1 hour

    Measured: During intervention

  4. SpO2/FiO2 Ratio Measured Before Prone Positioning

    Measure of oxygenation using pulse oximetry before intervention where ABG not available

    Measured: Immediately before intervention

  5. SpO2/FiO2 Ratio After 1 Hour in Prone Positioning

    Measure of oxygenation 1 hour after intervention where ABG not available

    Measured: During Intervention

  6. Number Requiring Increase in Ventilatory Assistance

    Number of patients in each group requiring an increase in the respiratory support from baseline high flow nasal cannula oxygen post randomization up to 28 days later, defined as need for continuous positive airway pressure (CPAP), bilevel positive airway pressure (biPAP)

    Measured: Up to 28 days post randomisation

  7. Work of Breathing Assessment (Respiratory Distress Scale)

    Measure of work of breathing in COVID-19 based on Oxygen Delivery Device, Oxygen Saturation and respiratory rate and accessory muscle use with 0-3 Mild, 4-6 Moderate and 7-10 Severe

    Measured: Immediately before and during intervention

  8. Changes in Bioimpedance Measures of Lung Edema in Patients in PP

    Substudy examining use of bioimpedance as a surrogate measure of lung edema following prone positioning

    Measured: During intervention

  9. Use of Awake Prone Positioning as a Rescue Intervention in Control Patients

    Number of patients who underwent rescue awake prone positioning in control patients by physicians in response to hypoxia

    Measured: Up to 28 days post randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2020
  2. Study start11 Jul 2020
  3. Primary completion26 Jan 2021
  4. Study completion26 Jan 2021

Why it stopped: Enrollment for trial was terminated on January 26, 2021 after a third interim analysis demonstrated that a pre-defined statistical criteria for efficacy were met as part of meta-trial study of awake prone positioning.

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04347941
Sponsor's protocol ID
APPROVE-CARE-2020
Acronym
APPROVE-CARE
Status last verified
Nov 2021
First submitted
8 Apr 2020
Last updated
2 Dec 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Electronic Case report form following informed consent, all patient identification removed, and individual patient response to intervention will be shared.

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 34425070

  • Tavernier 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

Questions about this trial

What is this clinical trial studying?

A study testing Prone Positioning in people with ARDS, Human and Mechanical Ventilation Complication, run by University College Hospital Galway at 1 site in Ireland.

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 6 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: stopped early, as of the sponsor's last update on 2 Dec 2021. 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 Ireland. 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?

Yes. Results are posted in the registry (first posted 2 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Effect of Prone Positioning on Requirement for Invasive Mechanical Ventilation or Death in Patients With COVID 19 Induced Respiratory Failure. (time frame: Up to 28 days post randomisation). 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 NCT04347941, 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 2 Dec 2021.

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