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Status unknownNCT03424798Updated Feb 7, 2018

Measuring Heart and Lung Function in Critical Care

An observational study in Respiratory Distress Syndrome, Adult, Critical Illness and Mechanical Ventilation Complication, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by University of Oxford · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 47 studies in Respiratory Distress Syndrome with a site in United Kingdom — 10 open to participants now, 13 under way, 3 of them phase 3. Respiratory Distress Syndrome · United Kingdom.

Planned enrollment
11th of 15
80 · median 132
Started
2017
with 2 others
Observational
16 of 47
4 open now
Registered
18th of 47
by date
Lead sponsor
2 of 47
University of Oxford

Among the 47 studies in Respiratory Distress Syndrome with a site in United Kingdom, this one is the 11th largest by planned enrollment of the 15 observational ones that give a count, is one of 3 that started in 2017, is one of 16 observational ones, and was the 18th registered.

Respiratory Distress Syndrome

1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.

Browse Respiratory Distress Syndrome studies →

Open to participants now

10 of the 47 studies in Respiratory Distress Syndrome with a site in United Kingdom are open now. Recruiting first, the newest first:

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All 10 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 194 Respiratory Distress Syndrome studies recruiting now, 118 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 51 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

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

Keywords

  • mechanical ventilation
  • lung function
  • cardiopulmonary monitoring
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

-mechanically ventilated patients in a critical care area

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients requiring mechanical ventilation in a critical care area

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • DeviceInspiwave

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

06

What researchers measure

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.

    Time frame: Sept 2020

Secondary outcomes

  1. 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.

    Time frame: Sept 2020

  2. 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.

    Time frame: Sept 2020

07

Study locations

1 of 1 sites recruiting
  • Oxford University Hospitals NHS Foundation Trust
    Oxford, United Kingdom
    Recruiting
    • Andrew Farmery · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Sep 2019, 23 months after the start.

Of 225 non-industry observational studies under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 23 months is close to that.

Counting every sponsor, half of 231 studies reached it within 24 months; a quarter within 12 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2017
First posted
Feb 7, 2018
StartActual
Oct 21, 2017
Primary completionEst.
Sep 2019
CompletionEst.
Sep 2020
Last update
Feb 7, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03424798
Responsible party
Sponsor
First posted
Feb 7, 2018
Start date
Oct 21, 2017
Primary completion
Sep 2019 (estimated)
Completion
Sep 2020 (estimated)
Last update
Feb 7, 2018

Study contacts

Andrew D Farmery, MD
Contact
andrew.farmery@nda.ox.ac.uk
+441865231420
Heather House
Contact
ouhtma@ouh.nhs.uk
+441865572242
Andrew D Farmery, MD
principal investigator · heather.house@admin.ox.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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