Prone Position to Improve Oxygenation in COVID-19 Patients Outside Critical Care

NCT04589936 | Unknown

• 1 other identifier: 284061
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Prone positioning is known to improve the PaO2/FiO2 ratio and reduce mortality in patients with ARDS managed in the critical care setting. Therefore, it is incorporated into regular clinical practice of managing patients with ARDS in critical care and is being used as such in the COVID-19 outbreak. Given that prone positioning is recommended by the Intensive Care Society in non-ventilated patients with COVID-19, there is an urgent need to better understand the physiological effects of prone positioning in such cases. Furthermore, the translation and applicability of such a low-cost non-invasive intervention in a wider group of patients with pneumonia not specific to covid-19 infection, is an important consideration that merits investigation. This single-centred observational study conducted at Cambridge University Hospitals NHS Foundation Trust aims to improve understanding of physiological effects of prone positioning in non-ventilated patients with COVID-19 and a control group of patients with non-COVID-19 related pneumonia. The study also aims to incorporate a small subset of patients, with an approximately even spread of COVID-19 and non-COVID cases, which allows for an additional exploratory descriptive report on prone positioning over a 24-hour period. This study proposes that prone positioning improves oxygenation in non-ventilated patients with pneumonia (COVID-19 related or not) requiring supplemental oxygen managed outside of the critical care setting.

Conditions

Pneumonia; Covid19

Keywords

Prone positioning; COVID-19; Pneumonia; Oxygenation

Outcome Measures

Primary Outcomes (1)

• Peripheral Oxygen saturation

  Oxygenation measured by peripheral saturations in relation to inspired oxygen (FiO2) when patient is prone versus a supine or lateral position using a Masimo device

  1 year (June 2021)

Secondary Outcomes (8)

• PaO2 :FiO2 ratio calculated from formulae

  1 year (June 2021)

• Respiratory rate measured with Masimo device

  1 year (June 2021)

• Heart rate measured with Masimo device

  1 year (June 2021)

• Blood pressure measured with Masimo device

  1 year (June 2021)

• Patient reported severity of breathlessness on a continuous linear scale of 0 to 10cm (10cm being the most severe)

  1 year (June 2021)

Study Arms (2)

COVID-19

EXPERIMENTAL

Non-ventilated patients with COVID-19

Procedure: Prone positioning

Pneumonia control

ACTIVE COMPARATOR

Patients with pneumonia unrelated to COVID-19 requiring supplemental O2.

Procedure: Prone positioning

Interventions

Prone positioning PROCEDURE

Patient will first lay supine for a given time period, followed by lateral position on either side, then prone position, lastly return to supine position. Participants are anticipated to stay in prone position for a minimum of 30min to a maximum of 2 hours depending on tolerability. Participants will be guided in how to independently position themselves and rotate through the cycle of positions.

Also known as: Proning

COVID-19; Pneumonia control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have confirmed or suspected COVID-19 or non-COVID pneumonia (confirmed with radiological changes)
• FiO2 ≥24% or requiring basic respiratory support (supplementary oxygen via face mask, nasal cannula, venturi, non-rebreathe bag) to achieve clinical target SpO2 (e.g. SpO2 92-96%), ensuring patient is on appropriately titrated oxygen to be within this range.
• Be able to provide informed consent
• Communicate and cooperate with the procedure
• Rotate and adjust position independently
• No anticipated airway issues

You may not qualify if:

• The presence of any of the following will mean participants are ineligible:
• Signs of respiratory distress (e.g. respiratory rate ≥35, accessory muscle use)
• Immediate need for intubation
• Haemodynamic instability or new arrhythmia
• Unstable spine/thoracic injury/recent abdominal surgery
• Pregnancy (2nd/3rd trimester)
• At risk of pressure sores/ulcers
• Neurological issues-frequent seizures
• Facial injury that would make prone position difficult
• Gastrointestinal issues-frequent vomiting or diarrhoea that would make prone position difficult

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 7PH, United Kingdom

RECRUITING

Related Publications (1)

• Elharrar X, Trigui Y, Dols AM, Touchon F, Martinez S, Prud'homme E, Papazian L. Use of Prone Positioning in Nonintubated Patients With COVID-19 and Hypoxemic Acute Respiratory Failure. JAMA. 2020 Jun 9;323(22):2336-2338. doi: 10.1001/jama.2020.8255.

  PMID: 32412581 BACKGROUND

MeSH Terms

Conditions

Pneumonia; COVID-19

Interventions

Prone Position

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jonathan Fuld

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Fuld

CONTACT

01223 256 337; jonathan.fuld@addenbrookes.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Respiratory and Acute medicine

Model Details: Case-control study design, with 1:1 for COVID-19 case versus pneumonia unrelated to COVID-19.

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 19, 2020
• Study Start: September 3, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)