Official Title
Accelerated Prone Position Ventilation of Patients With COVID-19
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.

Withdrawn
COVID-19

Procedure: Prone position ventilation

Patients are placed in a prone position using specialized equipment.

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Denmark
Locations

Nordsjællands Hospital
Hillerød, Region Hovedstanden, Denmark

Morten H Bestle, MD, PhD, Principal Investigator
Nordsjællands Hospital, University of Copenhagen

Nordsjaellands Hospital
NCT Number
Keywords
Prone position ventilation
ARDS
Intensive care unit
Respiratory failure
MeSH Terms
COVID-19