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Accelerated Prone Position Ventilation of Patients With COVID-19 (PROVENT-COVID)

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: NCT04384900
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Nordsjaellands Hospital

Brief Summary:
Prone position ventilation is frequently used in the ICU to treat severe hypoxemia in patients with COVID-19 associated acute respiratory distress syndrome (ARDS). The aim of the PROVENT-COVID study is to assess whether applying prone position ventilation immediately after intubation reduces the duration of mechanical ventilation compared to prone position ventilation according to standard criteria for prone position.

Condition or disease Intervention/treatment Phase
COVID-19 Procedure: Prone position ventilation Not Applicable

Detailed Description:

In patients with COVID-19 the incidence of ARDS is 15% and the all-cause mortality 4%. No treatment has been shown to improve the outcome of these patients.

Mechanical ventilation in the prone position decreases mortality with around 50% when applied to patients with severe respiratory failure. Applying prone position earlier in patients with COVID-19 could have several benefits, but may also carry significant side-effects and an increased workload for the health-care personnel. It is urgently needed to assess whether this potential life-saving intervention is effective.

The aim of the PROVENT-COVID is to determine whether prone position ventilation, initiated immediately after intubation, lead to more days alive without respiratory support compared to prone position initiated according to standard indication in patients with COVID-19 associated respiratory failure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accelerated Prone Position Ventilation of Patients With COVID-19
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Accelerated prone position
Prone position ventilation initiated as soon as possible following intubation. The patients are maintained in a prone position for 12-16 hrs daily for 5 days, unless one of the following criteria are met: Substantial improvement and/or imminent extubation, Worsening oxygenation with prone position, Serious Adverse Reactions (SARs) occurring during a prone session and leading to its immediate interruption. Following the five day intervention period, prone position ventilation will be continued according to the intervention in the control group
Procedure: Prone position ventilation
Patients are placed in a prone position using specialized equipment.

Active Comparator: Standard prone position
Standard of care: Prone position applied according to standard indications (severe ARDS not improving with 12-24 hours of mechanical ventilation with PaO2-to-FiO2 ratio (PAF) < 150 mmHg with FiO2 of ≥0.6, a positive end-expiratory pressure (PEEP) of ≥5 cm of water, and a tidal volume of about 6 ml per kilogram of predicted body weight). Until one of the following are met: Substantial improvement and/or imminent extubation, Worsening oxygenation with prone position, Serious Adverse Reactions (SARs) occurring during a prone session and leading to its immediate interruption.
Procedure: Prone position ventilation
Patients are placed in a prone position using specialized equipment.




Primary Outcome Measures :
  1. Days alive without respiratory life support (invasive mechanical ventilation) at day 28. [ Time Frame: 28 days after randomization ]
    Number of days where patients are alive and not receiving mechanical ventilation


Secondary Outcome Measures :
  1. Days alive and out of hospital on day 28 after randomisation. [ Time Frame: 28 days ]
    Number of days alive and out of hospital

  2. Days alive at day 28 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy). [ Time Frame: 28 days ]
    Number of days where patients are alive and not receiving life support

  3. Number of participants with one or more SARs as described in section 6.1 plus incidence of new persistent nerve injury or grade 3 or 4 (full-thickness skin loss or worse) pressure wounds. [ Time Frame: 28 days ]
    Number of patients with severe adverse reaction

  4. 28-days all-cause mortality. [ Time Frame: 28 days ]
    Number patients who have died



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age ≥ 18 years of age.
  • Admitted to an intensive care unit.
  • Indication for intubation and mechanical ventilation
  • No suspicion of significant cardiac failure induced pulmonary edema.
  • Suspected COVID-19 or positive SARS-Cov-2 PCR or equivalent diagnostic test.
  • Inclusion as soon as possible and maximum 12 hours after intubation.

Exclusion Criteria:

  • Contraindication for prone position ventilation: Suspected high intracranial pressure, massive hemoptysis requiring an immediate surgical or interventional radiology procedure, tracheal surgery or sternotomy during the previous 15 days, serious facial trauma or facial surgery during the previous 15 days, cardiac pacemaker inserted in the last 2 days, unstable spine, femur, or pelvic fractures, single anterior chest tube with air leaks, body constitution that is incompatible with prone position ventilation (i.e. high BMI)
  • Admitted under duress (psychiatry).
  • Pregnant or breastfeeding.
  • Mechanical ventilation in prone position prior to inclusion in the trial

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): NCT04384900


Contacts
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Contact: Morten H Bestle, MD,PhD 48 29 48 29 morten.bestle@regionh.dk
Contact: Theis S Itenov, MD,PhD 48 29 75 24 theis.skovsgaard.itenov@regionh.dk

Locations
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Denmark
Nordsjællands Hospital Recruiting
Hillerød, Region Hovedstanden, Denmark, 3400
Contact: Theis S Itenov, MD, PhD    +45 48 29 75 25    theis.skovsgaard.itenov@regionh.dk   
Sponsors and Collaborators
Nordsjaellands Hospital
Investigators
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Principal Investigator: Morten H Bestle, MD, PhD Nordsjællands Hospital, University of Copenhagen

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Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT04384900    
Other Study ID Numbers: H-20027361
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made publicly available 9 months after the publication of the outcome data according to the recent ICMJE recommendations
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: 9 months after publication of primary results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nordsjaellands Hospital:
Prone position ventilation
ARDS
intensive care unit
respiratory failure