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.

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 Overview

• Status: Unknown
• Conditions: Critical Illness; Respiratory Distress Syndrome, Adult; Mechanical Ventilation Complication; Haemodynamic Instability; Gas Exchange Impairment
• Intervention / Treatment: Device: Inspiwave

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom
    • Recruiting
    • Oxford University Hospitals NHS Foundation Trust
    • Contact: Andrew Farmery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

-mechanically ventilated patients in a critical care area

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Sept 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Sept 2020

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Andrew D Farmery, MD, heather.house@admin.ox.ac.uk

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2017
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: August 9, 2017
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: lung function; mechanical ventilation; cardiopulmonary monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Critical Illness; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 212665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No