Accelerated Prone Position Ventilation of Patients With COVID-19

COVID-19 Clinical Trial

— PROVENT-COVID  

Official title:

Accelerated Prone Position Ventilation of Patients With COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04384900
• Other study ID #: H-20027361
• Status: Withdrawn
• Phase: N/A
• Start date: May 11, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: May 2021
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Prone position ventilation
Patients are placed in a prone position using specialized equipment.

Locations

Country	Name	City	State
Denmark	Nordsjællands Hospital	Hillerød	Region Hovedstanden

Sponsors (1)

Lead Sponsor	Collaborator
Nordsjaellands Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive without respiratory life support (invasive mechanical ventilation) at day 28.	Number of days where patients are alive and not receiving mechanical ventilation	28 days after randomization
Secondary	Days alive and out of hospital on day 28 after randomisation.	Number of days alive and out of hospital	28 days
Secondary	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	28 days
Secondary	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
Secondary	28-days all-cause mortality.	Number patients who have died	28 days