Measuring Heart and Lung Function in Critical Care

NCT ID: NCT03424798

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-21

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inspiwave

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew D Farmery, MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrew D Farmery, MD

Role: CONTACT

+441865231420

Heather House

Role: CONTACT

+441865572242

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Andrew Farmery

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

212665

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.