Accelerated Prone Position Ventilation of Patients With COVID-19

NCT04384900 | Withdrawn DMC

• 1 other identifier: H-20027361
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Prone position ventilation; ARDS; intensive care unit; respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Days alive and out of hospital on day 28 after randomisation.

  28 days

• Days alive at day 28 without life support (vasopressor/inotropic support, invasive mechanical ventilation or renal replacement therapy).

  28 days

• 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

• 28-days all-cause mortality.

  28 days

Study Arms (2)

Accelerated prone position

EXPERIMENTAL

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

Procedure: Prone position ventilation

Standard prone position

ACTIVE COMPARATOR

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.

Procedure: Prone position ventilation

Interventions

Prone position ventilation PROCEDURE

Patients are placed in a prone position using specialized equipment.

Accelerated prone position; Standard prone position

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Nordsjællands Hospital

Hillerød, Region Hovedstanden, 3400, Denmark

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Morten H Bestle, MD, PhD

  Nordsjællands Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 12, 2020
• Study Start: May 11, 2020
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 9 months after publication of primary results

Locations

DK (1)