Study Detail

RECOVERY - Respiratory Support

Ventilation Strategies in COVID-19; CPAP, High-flow, and standard care

Status: Open

Type: Interventional

Funder: Department of Health and Social Care

Sponsor: University of Warwick

CI: Gavin Perkins

IRAS-Number: 282338

CPMS-ID: 45518

Approval Date: 13 April 2020

Summary:

COVID-19 can cause serious breathing difficulties and it is important to provide artificial methods to help the patient to breathe. This study will compare three different ways of providing respiratory support to patients suspected or confirmed of having COVID-19 to see which work best. All three methods are currently in use in clinical practice and patients will receive one of these, chosen at random. • High Flow Nasal Oxygen (HFNO) • Continuous Positive Airway Pressure (CPAP) • Normal care involving regular oxygen therapy. Up to around 4000 patients will be included in the study from 60+ hospital sites. It will look at which treatment is more effective in relation to survival of patients and the need for intubation (tube inserted in to patient's throat to help them breathe). It will also look at how long it takes to intubate a patient, time to death, survival rate in critical care, and the length of stay, both in critical care and overall over a 30 day period, or until the patient leaves hospital (whichever comes later).

Description:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged at the end of 2019 as a new coronavirus, resulting in a current global pandemic of respiratory illness, Coronavirus Disease 2019 (COVID-19). This illness can cause serious breathing difficulties and it is important to provide ventilatory (lung or respiratory system) methods to support the patient to breathe. Deciding which form of ventilatory support for patients with COVID-19 is the most effective is critical to ensure the best therapy is given to patients and to protect vital UK critical care resources and NHS organisations. The trial will also have the potential to provide information on the global ventilation practice for patients with COVID-19. This trial will look at three different approaches to providing ventilatory support to patients suspected or confirmed COVID-19, all of which are currently in use in clinical practice at present; High Flow Nasal Oxygen (HFNO), Continuous Positive Airway Pressure (CPAP), and standard care involving regular oxygen therapy. We will see which is more effective in relation to survival of patients and intubation (tube inserted in to patient's throat to help them breathe). There is currently little evidence to support the use of HFNO or CPAP compared to standard care in patients with COVID-19. This trial will also look at other important outcomes in patients whilst they are in hospital such as how long it takes to intubate a patient, time to death, survival in critical care and hospital stay and length of critical care and hospital stay up until 30 days or hospital discharge, whichever comes later. The trial is a multi-centre randomised controlled trial taking place in 40 hospital sites in the UK with the aim to recruit 4,002 patients. The trial will take place over a period of 18 months.

Study URL:

http://www.warwick.ac.uk/recovery-rs

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