Reducing Oxygen Consumption in Critical Care

Mechanical Ventilation Complication Clinical Trial

— ROCC  

Official title:

Reducing Oxygen Consumption in Critical Care (ROCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796817
• Other study ID #: 310355
• Status: Completed
• Start date: May 25, 2023
• Est. completion date: October 10, 2023

Study information

• Verified date: November 2023
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Device:
• Ventilator modification
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%)

Locations

Country	Name	City	State
United Kingdom	The Royal Brompton and Harefield Hospitals	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial blood gas analysis - baseline	PaO2 with and without modification fitted	After 10 minutes
Secondary	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
Secondary	Arterial blood gas - CO2	Arterial CO2 levels at each experimental condition	After 10 minutes of each experimental condition