Mechanical Ventilation ComplicationROCCNCT05796817
Reducing Oxygen Consumption in Critical Care
An observational study of Mechanical Ventilation Complication, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Ventilator modification
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 May 2023to 10 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Mechanically ventilated patients in critical care
Who may be able to join
- 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
Who cannot join
- Thought to be clinically unstable during study protocol (2 hours)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Brompton and Harefield Hospitals
London, SW6 3NP
About this study
Official title: 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.
Read more
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
- Being tested
- Ventilator modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventilator modificationDevice
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%)
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial blood gas analysis - baseline
PaO2 with and without modification fitted
Measured: After 10 minutes
Secondary outcomes (2)
Arterial blood gas - modification and oxygen change
Oxygenation with and without modification in place with 1, 2 and 3 litres added to baseline FiO2
Measured: After 10 minutes of each experimental condition
Arterial blood gas - CO2
Arterial CO2 levels at each experimental condition
Measured: After 10 minutes of each experimental condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start25 May 2023
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796817
- Sponsor's protocol ID
- 310355
- Acronym
- ROCC
- Status last verified
- Nov 2023
- First submitted
- 21 Mar 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Oxygen Consumption in Critical Care (ROCC)
- ClinicalTrials.gov ID
- NCT05796817
- Acronym / sponsor ID
- ROCC / 310355
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated patients in critical care
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Thought to be clinically unstable during study protocol (2 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventilator modificationThe 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%) | Device | – |
Primary outcome
Arterial blood gas analysis - baseline
Time frame: After 10 minutes
PaO2 with and without modification fitted
2 secondary outcomes
Arterial blood gas - modification and oxygen change
Time frame: After 10 minutes of each experimental condition
Arterial blood gas - CO2
Time frame: After 10 minutes of each experimental condition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Mechanical Ventilation Complication
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Behavioral Economic & Staffing Strategies in the ICU
Implementation Science, Delirium
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial blood gas analysis - baseline (time frame: After 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.