Measuring Heart and Lung Function in Critical Care

NCT03424798 | Unknown

• 1 other identifier: 212665
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

mechanical ventilation; lung function; cardiopulmonary monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

Inspiwave DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

-mechanically ventilated patients in a critical care area

You may qualify if:

• patients requiring mechanical ventilation in a critical care area

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome; Critical Illness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew D Farmery, MD

  heather.house@admin.ox.ac.uk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew D Farmery, MD

CONTACT

+441865231420; andrew.farmery@nda.ox.ac.uk

Heather House

CONTACT

+441865572242; ouhtma@ouh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: February 7, 2018
• Study Start: October 21, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2020
• Last Updated: February 7, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)