Accelerated Prone Position Ventilation of Patients With COVID-19

NCT ID: NCT04384900

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-11
• Study Completion Date: 2021-05-25

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Accelerated prone position

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

Group Type: EXPERIMENTAL

Prone position ventilation

Intervention Type: PROCEDURE

Patients are placed in a prone position using specialized equipment.

Standard prone position

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.

Group Type: ACTIVE_COMPARATOR

Prone position ventilation

Intervention Type: PROCEDURE

Patients are placed in a prone position using specialized equipment.

Interventions

Prone position ventilation

Patients are placed in a prone position using specialized equipment.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morten H Bestle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nordsjællands Hospital, University of Copenhagen

Locations

Nordsjællands Hospital

Hillerød, Region Hovedstanden, Denmark

Countries

Denmark

Other Identifiers

H-20027361

Identifier Type: -

Identifier Source: org_study_id