Respiratory Distress Syndrome, AdultNCT03424798
Measuring Heart and Lung Function in Critical Care
An observational study of Respiratory Distress Syndrome, Adult and Critical Illness, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This is a feasibility study of the use of a novel technique called 'Inspiwave' to measure heart and lung function in adult patients in critical care. The preliminary work has already been undertaken in animal models and in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Critical Illness, Mechanical Ventilation Complication
- What is being tested?
- Inspiwave
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2017to Sep 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: -mechanically ventilated patients in a critical care area
Who may be able to join
- patients requiring mechanical ventilation in a critical care area
Who cannot join
- decision of participant not to be included
- consultee declaration not to be included
- Severely impaired gas exchange as declared by the managing clinician
- oxygen requirement exceeding 90% FIO2
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
Andrew Farmery
About this study
Official title: Measuring Heart and Lung Function in Critical Care: A Feasibility Study to Assess the Use of a Novel Device to Monitor Cardiorespiratory Function in Mechanically Ventilated Patients in Critical Care.
This is a feasibility study of the use of a novel technique called 'Inspiwave' to measure heart and lung function in adult patients in critical care.
The preliminary work has already been undertaken in animal models and in healthy volunteers. The ultimate aim of this study is to develop a clinical tool for measuring (and therefore being able to make treatment changes based on) indices of heart and lung function in critical care patients. This study is the first assessment of the technique in this population, and whilst we know it works in patients undergoing general anaesthesia, we now need to assess whether Inspiwave can be used at all in critical care patients who may have much more physiological derangement. The purpose of this phase of the research is to determine whether it is feasible to use Inspiwave in critical care.
Inspiwave generates a sinusoidally modulated tracer gas signal in the inspired air. It also measures the resulting signal in the expired air. The unique handling of this signal by the patient can used be to derive key variables related to cardiopulmonary function such as lung volume, pulmonary blood flow, the deadspace (wasted ventilation) and the degree to which ventilation and blood flow are non-uniform. These are 'vital signs' in sick patients, yet are currently technically difficult to measure, particularly non-invasively.
- Conditions
- Respiratory Distress Syndrome, Adult, Critical Illness, Mechanical Ventilation Complication, Haemodynamic Instability, Gas Exchange Impairment
- Being tested
- Inspiwave
- Keywords
- mechanical ventilation, lung function, cardiopulmonary monitoring
- Medical subject headings
- Respiratory Distress Syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InspiwaveDevice
patients are monitored with the Inspiwave device. A low dose inert tracer gas is added to the inspred air
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of any numerical values of effective lung volume and pulmonary blood flow
We wish to know whether the technique can be applied, and whether the signal to noise ratio allows computation of the variables of interest. It is yet unclear whether or not the device can operate in a critical care environment.
Measured: Sept 2020
Secondary outcomes (2)
Comparison of measurements of effective lung volume and pulmonary blood flow under changes in observed clinical condition.
To observe if changes in clinical condition can be detected by the device.
Measured: Sept 2020
Signal:noise ratio of measured data.
If values for effective lung volume and pulmonary blood flow can be produced, are these with adequate signal:noise ratio to allow inverse modelling.
Measured: Sept 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start21 Oct 2017
- Primary completionSep 2019 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Farmery, MD, Principal investigator, heather.house@admin.ox.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424798
- Sponsor's protocol ID
- 212665
- Status last verified
- Jan 2018
- First submitted
- 9 Aug 2017
- Last updated
- 7 Feb 2018
- 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 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Heart and Lung Function in Critical Care: A Feasibility Study to Assess the Use of a Novel Device to Monitor Cardiorespiratory Function in Mechanically Ventilated Patients in Critical Care.
- ClinicalTrials.gov ID
- NCT03424798
- Acronym / sponsor ID
- 212665
- Conditions
- Respiratory Distress Syndrome, Adult, Critical Illness, Mechanical Ventilation Complication, Haemodynamic Instability, Gas Exchange Impairment
- Keywords
- mechanical ventilation, lung function, cardiopulmonary monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 21 Oct 2017 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 7 Feb 2018 (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.
This is a feasibility study of the use of a novel technique called 'Inspiwave' to measure heart and lung function in adult patients in critical care.
The preliminary work has already been undertaken in animal models and in healthy volunteers. The ultimate aim of this study is to develop a clinical tool for measuring (and therefore being able to make treatment changes based on) indices of heart and lung function in critical care patients. This study is the first assessment of the technique in this population, and whilst we know it works in patients undergoing general anaesthesia, we now need to assess whether Inspiwave can be used at all in critical care patients who may have much more physiological derangement. The purpose of this phase of the research is to determine whether it is feasible to use Inspiwave in critical care.
Inspiwave generates a sinusoidally modulated tracer gas signal in the inspired air. It also measures the resulting signal in the expired air. The unique handling of this signal by the patient can used be to derive key variables related to cardiopulmonary function such as lung volume, pulmonary blood flow, the deadspace (wasted ventilation) and the degree to which ventilation and blood flow are non-uniform. These are 'vital signs' in sick patients, yet are currently technically difficult to measure, particularly non-invasively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- -mechanically ventilated patients in a critical care area
Key inclusion criteria (1 listed)
- patients requiring mechanical ventilation in a critical care area
Key exclusion criteria (4 listed)
- decision of participant not to be included
- consultee declaration not to be included
- Severely impaired gas exchange as declared by the managing clinician
- oxygen requirement exceeding 90% FIO2
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 |
|---|---|---|
| Inspiwavepatients are monitored with the Inspiwave device. A low dose inert tracer gas is added to the inspred air | Device | – |
Primary outcome
Production of any numerical values of effective lung volume and pulmonary blood flow
Time frame: Sept 2020
We wish to know whether the technique can be applied, and whether the signal to noise ratio allows computation of the variables of interest. It is yet unclear whether or not the device can operate in a critical care environment.
2 secondary outcomes
Comparison of measurements of effective lung volume and pulmonary blood flow under changes in observed clinical condition.
Time frame: Sept 2020
Signal:noise ratio of measured data.
Time frame: Sept 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Andrew D Farmery, MD principal investigator
heather.house@admin.ox.ac.uk
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 Respiratory Distress Syndrome, Adult and Critical Illness, run by University of Oxford 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew D Farmery, MD (+441865231420, andrew.farmery@nda.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of any numerical values of effective lung volume and pulmonary blood flow (time frame: Sept 2020). 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 7 Feb 2018.