Clinical trial NCT03424798: Measuring Heart and Lung Function in Critical Care
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome, Adult
Critical Illness
Mechanical Ventilation Complication
Haemodynamic Instability
Gas Exchange Impairment
Keywords: mechanical ventilation
lung function
cardiopulmonary monitoring
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -mechanically ventilated patients in a critical care area

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.


Eligibility criteria: 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

Primary outcomes:
measure: Production of any numerical values of effective lung volume and pulmonary blood flow
timeFrame: Sept 2020
Secondary outcomes:
measure: Comparison of measurements of effective lung volume and pulmonary blood flow under changes in observed clinical condition.
timeFrame: Sept 2020
measure: Signal:noise ratio of measured data.
timeFrame: Sept 2020
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
affiliation: heather.house@admin.ox.ac.uk
name: Andrew D Farmery, MD
role: PRINCIPAL_INVESTIGATOR
References: