Accelerated Prone Position Ventilation of Patients With COVID-19

Not Applicable

Withdrawn

• Conditions: COVID-19

• Registration Number: NCT04384900
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-05-11
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Status Verified: 2021-05
• Primary Completion: 2021-05-25
• Study Completion: 2021-05-25
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
28-days all-cause mortality.	28 days	Number patients who have died
Days alive and out of hospital on day 28 after randomisation.	28 days	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).	28 days	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.	28 days	Number of patients with severe adverse reaction

Trial Locations

Locations (1)

Nordsjællands Hospital; 🇩🇰 Hillerød, Region Hovedstanden, Denmark