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Clinical Trials/NCT03424798
NCT03424798
Unknown
Not Applicable

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.

University of Oxford1 site in 1 country80 target enrollmentOctober 21, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Adult
Sponsor
University of Oxford
Enrollment
80
Locations
1
Primary Endpoint
Production of any numerical values of effective lung volume and pulmonary blood flow
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 21, 2017
End Date
September 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Comparison of measurements of effective lung volume and pulmonary blood flow under changes in observed clinical condition.(Sept 2020)
  • Signal:noise ratio of measured data.(Sept 2020)

Study Sites (1)

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