Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE (APPROVE-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347941
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
John Laffey, University College Hospital Galway

Brief 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. 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.

Condition or disease Intervention/treatment Phase
ARDS, Human Mechanical Ventilation Complication COVID19 Procedure: Prone Positioning Procedure: Standard of care. Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Awake Prone Positioning to Reduce Invasive VEntilation in COVID-19 Induced Acute Respiratory failurE
Actual Study Start Date : July 11, 2020
Estimated Primary Completion Date : June 11, 2021
Estimated Study Completion Date : September 11, 2021


Arm Intervention/treatment
Experimental: Prone Positioning
Intervention patients will remain up to 16 hours per day in Prone Positioning with 45 minutes breaks for meals
Procedure: Prone Positioning
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

Active Comparator: Standard Care
Control patients will receive full standard care. Prone Positioning as a rescue intervention is permitted and is recorded.
Procedure: Standard of care.
Standard of care. Prone positioning may be administered as a rescue therapy




Primary Outcome Measures :
  1. The effect of prone positioning on requirement for invasive mechanical ventilation in patients with COVID 19 induced respiratory failure. [ Time Frame: Up to 28 days post randomisation ]
    A measure of effect of awake prone positioning in reducing requirement for invasive mechanical ventilation.


Secondary Outcome Measures :
  1. Length of time tolerating prone positioning [ Time Frame: Daily during intervention up to 28 days post randomisation ]
    Total time spent in prone and supine position as recorded by nurse

  2. PaO2/FiO2 measured before prone positioning [ Time Frame: Immediately before intervention ]
    Measure of change in oxygenation before intervention

  3. PaO2/FiO2 ratio after 1 hours of prone positioning [ Time Frame: During intervention ]
    Measure of change in oxygenation following intervention

  4. SpO2/FiO2 ratio measured before prone positioning [ Time Frame: Immediately before intervention ]
    Measure of change in oxygenation using pulse oximetry before intervention where ABG not available

  5. SpO2/FiO2 ratio after 1 hours of prone positioning [ Time Frame: During Intervention ]
    Measure of change in oxygenation before intervention where ABG not available

  6. Number requiring increase in ventilatory assistance (CPAP+BIPAP+IMV etc) [ Time Frame: Up to 28 days post randomisation ]
    Escalation of ventilatory support

  7. Work of breathing assessment (Respiratory distress scale) [ Time Frame: Immediately before and during intervention ]
    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

  8. Changes in bioimpedance measures of lung edema in patients in PP [ Time Frame: During intervention ]
    Substudy examining use of bioimpedance as a surrogate measure of lung edema following prone positioning

  9. Use of awake prone positioning as a rescue intervention in control patients [ Time Frame: Up to 28 days post randomisation ]
    Rescue awake prone positioning in control patients in response to hypoxia



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347941


Contacts
Layout table for location contacts
Contact: Bairbre A McNicholas, MB BCh PhD 353838624777 bairbre.nimhaille@hse.ie
Contact: David Cosgrave, MB BCh FARSI davidcosgrave9@hotmail.com

Locations
Layout table for location information
Ireland
Galway University Hospital Recruiting
Galway, Ireland
Galway University Hospital Recruiting
Galway, Ireland
Contact: Bairbre A McNicholas, MB BCh BAO PhD MRCPI FJFICMI    353838624777    bairbre.nimhaille@hse.ie   
Contact: John G Laffey, MD    35391495662    john.laffey@nuigalway.ie   
Sponsors and Collaborators
University College Hospital Galway
Layout table for additonal information
Responsible Party: John Laffey, Professor, Anaesthesia and Intensive Care Medicine, School of Medicine, NUI Galway, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT04347941    
Other Study ID Numbers: APPROVE-CARE-2020
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Electronic Case report form following informed consent, all patient identification removed, and individual patient response to intervention will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: up to 15 years post study

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases