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OpenTrials
Completed

NCT Number: NCT05796817

Reducing Oxygen Consumption in Critical Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Royal Brompton and Harefield Hospitals

London, SW6 3NP, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ventilator modification

Device

The ventilator modification will be fitted to a ResMed Lumis 150, Breas® Nippy 4+ or Vivo 1, 2 or 3 ventilator. The participants oxygen level will be measured with and without the modification in place at their baseline ventilation, and with 1, 2 and 3 litres oxygen extra to their baseline. the researcher will then leave the modification on and slowly reduce the oxygen going into the ventilator, maintaining the participants SP02 at an acceptable level (>95%)

Primary outcomes

  1. Arterial blood gas analysis - baseline

    Time frame: After 10 minutes

    PaO2 with and without modification fitted

Secondary outcomes

  1. Arterial blood gas - modification and oxygen change

    Time frame: After 10 minutes of each experimental condition

    Oxygenation with and without modification in place with 1, 2 and 3 litres added to baseline FiO2

  2. Arterial blood gas - CO2

    Time frame: After 10 minutes of each experimental condition

    Arterial CO2 levels at each experimental condition

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

Reducing Oxygen Consumption in Critical Care (ROCC)

Acronym: ROCC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 4, 2023
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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