Reducing Oxygen Consumption in Critical Care (ROCC)

Reducing Oxygen Consumption in Critical Care (ROCC)

In normal practice oxygen supply can be easily met with existing hospital infrastructure. COVID - 19 however results in lung damage which greatly increases the amount of oxygen patients require - as a consequence some hospitals in the UK and other countries had situations where there was not enough oxygen for their inpatients.

COVID - 19 has caused many more patients to requiring assistance with their breathing using a ventilator. Due to the limited supply of sophisticated ventilators that 're-use' oxygen patients breathe out, some hospitals have used ventilators normally used by patients at home (domiciliary ventilators). Whilst these are inexpensive and commonly available, any oxygen the patient breathes out is simply released into the atmosphere.

The address this problem, and in turn reduce the oxygen demand on hospital infrastructure the biomedical engineering team (BME) at the Royal Brompton Hospital, London devised a simple 3-D printed modification which captures and reuses oxygen on commonly used domiciliary ventilators. Laboratory testing found this modification can increase the oxygen given by the ventilator without increasing the oxygen consumption of the ventilator - effectively reducing oxygen demand on hospital infrastructure.

This study will evaluate this modification in patients admitted to intensive care requiring assistance with their breathing. This will involve measuring oxygen levels on domiciliary ventilators (Breas Nippy 4+, ResMed Lumis 150 or Vivo 1, 2 or 3) with and without the modification and with small increases in oxygen supplied to the patient for a total study period of 2 hours.

Study Overview

• Status: Recruiting
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Device: Ventilator modification

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW6 3NP
    • Recruiting
    • The Royal Brompton and Harefield Hospitals
    • Contact: Timothy Jenkins, BSc; Phone Number: 82549 020 7352 8121; Email: t.jenkins@rbht.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients in critical care

Description

Inclusion Criteria:

• Patient in critical care using a ResMed LumisTM 150, Breas® Nippy 4+ or Vivo 1, 2 or 3 ventilator or deemed safe by treating consultant safe to switch to one.
• 28% or more of entrained oxygen (FiO2)
• Judged to be safe to tolerate increased fraction of inspired oxygen for periods of 10 minutes
• Arterial line insitu for clinical reasons

Exclusion Criteria:

• Thought to be clinically unstable during study protocol (2 hours)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood gas analysis - baseline	PaO2 with and without modification fitted	After 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood gas - modification and oxygen change	Oxygenation with and without modification in place with 1, 2 and 3 litres added to baseline FiO2	After 10 minutes of each experimental condition
Arterial blood gas - CO2	Arterial CO2 levels at each experimental condition	After 10 minutes of each experimental condition

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 310355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No