Reducing Oxygen Consumption in Critical Care

NCT05796817 | Completed

• 1 other identifier: 310355
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation Complication

Outcome Measures

Primary Outcomes (1)

• Arterial blood gas analysis - baseline

  PaO2 with and without modification fitted

  After 10 minutes

Secondary Outcomes (2)

• Arterial blood gas - modification and oxygen change

  After 10 minutes of each experimental condition

• Arterial blood gas - CO2

  After 10 minutes of each experimental condition

Interventions

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%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mechanically ventilated patients in critical care

You may qualify if:

• 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.
• % 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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

The Royal Brompton and Harefield Hospitals

London, SW6 3NP, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: May 25, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)