Measuring Heart and Lung Function in Critical Care

• Sponsor: University of Oxford (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03424798
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 34.4
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome, Adult; Critical Illness; Mechanical Ventilation Complication; Haemodynamic Instability; Gas Exchange Impairment	Device: Inspiwave

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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.
• Actual Study Start Date: Oct 21, 2017
• Anticipated Primary Completion Date: Sep 1, 2019
• Anticipated Study Completion Date: Sep 1, 2020

Outcome Measures

Primary Outcome Measures

1. Production of any numerical values of effective lung volume and pulmonary blood flow [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 Outcome Measures

1. Comparison of measurements of effective lung volume and pulmonary blood flow under changes in observed clinical condition. [Sept 2020]

   To observe if changes in clinical condition can be detected by the device.

2. Signal:noise ratio of measured data. [Sept 2020]

   If values for effective lung volume and pulmonary blood flow can be produced, are these with adequate signal:noise ratio to allow inverse modelling.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oxford University Hospitals NHS Foundation Trust	Oxford		United Kingdom

Sponsors and Collaborators

• University of Oxford

Investigators

• Principal Investigator: Andrew D Farmery, MD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT03424798
• Other Study ID Numbers: 212665
• First Posted: Feb 7, 2018
• Last Update Posted: Feb 7, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Oxford: mechanical ventilation; lung function; cardiopulmonary monitoring
• Additional relevant MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Critical Illness

Study Results

No Results Posted as of Feb 7, 2018