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

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prone position ventilation
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Prone position ventilation, ARDS, intensive care unit, respiratory failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nordsjællands Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Accelerated prone position

Standard prone position

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Days alive without respiratory life support (invasive mechanical ventilation) at day 28.
Number of days where patients are alive and not receiving mechanical ventilation

Secondary Outcome Measures

Days alive and out of hospital on day 28 after randomisation.
Number of days alive and out of hospital
Days alive at day 28 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy).
Number of days where patients are alive and not receiving life support
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.
Number of patients with severe adverse reaction
28-days all-cause mortality.
Number patients who have died

Full Information

First Posted
May 11, 2020
Last Updated
May 26, 2021
Sponsor
Nordsjaellands Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04384900
Brief Title
Accelerated Prone Position Ventilation of Patients With COVID-19
Acronym
PROVENT-COVID
Official Title
Accelerated Prone Position Ventilation of Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Primary investigators
Study Start Date
May 11, 2020 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordsjaellands Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Prone position ventilation, ARDS, intensive care unit, respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accelerated prone position
Arm Type
Experimental
Arm Description
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
Arm Title
Standard prone position
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prone position ventilation
Intervention Description
Patients are placed in a prone position using specialized equipment.
Primary Outcome Measure Information:
Title
Days alive without respiratory life support (invasive mechanical ventilation) at day 28.
Description
Number of days where patients are alive and not receiving mechanical ventilation
Time Frame
28 days after randomization
Secondary Outcome Measure Information:
Title
Days alive and out of hospital on day 28 after randomisation.
Description
Number of days alive and out of hospital
Time Frame
28 days
Title
Days alive at day 28 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy).
Description
Number of days where patients are alive and not receiving life support
Time Frame
28 days
Title
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.
Description
Number of patients with severe adverse reaction
Time Frame
28 days
Title
28-days all-cause mortality.
Description
Number patients who have died
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten H Bestle, MD, PhD
Organizational Affiliation
Nordsjællands Hospital, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordsjællands Hospital
City
Hillerød
State/Province
Region Hovedstanden
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
9 months after publication of primary results

Learn more about this trial

Accelerated Prone Position Ventilation of Patients With COVID-19

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