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Measuring Heart and Lung Function in Critical Care

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03424798
Enrollment
80
Registered
2018-02-07
Start date
2017-10-21
Completion date
2020-09-30
Last updated
2018-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Gas Exchange Impairment, Haemodynamic Instability, Mechanical Ventilation Complication, Respiratory Distress Syndrome, Adult

Keywords

mechanical ventilation, lung function, cardiopulmonary monitoring

Brief 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. 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.

Interventions

DEVICEInspiwave

patients are monitored with the Inspiwave device. A low dose inert tracer gas is added to the inspred air

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients requiring mechanical ventilation in a critical care area

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Production of any numerical values of effective lung volume and pulmonary blood flowSept 2020We 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.

Secondary

MeasureTime frameDescription
Comparison of measurements of effective lung volume and pulmonary blood flow under changes in observed clinical condition.Sept 2020To observe if changes in clinical condition can be detected by the device.
Signal:noise ratio of measured data.Sept 2020If values for effective lung volume and pulmonary blood flow can be produced, are these with adequate signal:noise ratio to allow inverse modelling.

Countries

United Kingdom

Contacts

Primary ContactAndrew D Farmery, MD
andrew.farmery@nda.ox.ac.uk+441865231420
Backup ContactHeather House
ouhtma@ouh.nhs.uk+441865572242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026