Measuring Heart and Lung Function in Critical Care

Critical Illness Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424798
• Other study ID #: 212665
• Status: Recruiting
• Phase: N/A
• First received: August 9, 2017
• Last updated: January 31, 2018
• Start date: October 21, 2017
• Est. completion date: September 2020

Study information

• Verified date: January 2018
• Source: University of Oxford
• Contact: Andrew D Farmery, MD
• Phone: +441865231420
• Email: andrew.farmery[@]nda.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Critical Illness
• Gas Exchange Impairment
• Haemodynamic Instability
• Mechanical Ventilation Complication
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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