Clinical trial NCT04384900: Accelerated Prone Position Ventilation of Patients With COVID-19
Official title: Accelerated Prone Position Ventilation of Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Keywords: Prone position ventilation
ARDS
intensive care unit
respiratory failure
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Days alive without respiratory life support (invasive mechanical ventilation) at day 28.
timeFrame: 28 days after randomization
Secondary outcomes:
measure: Days alive and out of hospital on day 28 after randomisation.
timeFrame: 28 days
measure: Days alive at day 28 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy).
timeFrame: 28 days
measure: 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.
timeFrame: 28 days
measure: 28-days all-cause mortality.
timeFrame: 28 days
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
state: Region Hovedstanden
Study officials:
affiliation: Nordsjællands Hospital, University of Copenhagen
name: Morten H Bestle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: