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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03463096
Other study ID # SP801
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2018
Est. completion date July 31, 2018

Study information

Verified date February 2018
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study of advanced lung physiology in altered gravitational conditions, consisting of respiratory measurements in healthy volunteers during high G acceleration on a long-arm human centrifuge.


Description:

The lung is highly gravity-dependent - it has little actual tissue mass and deforms under its own weight. This is relevant to astronauts in space, but is actually much more broadly important to life on Earth. Every time we change our posture - for example from lying to standing - the direction in which gravity acts across the lung changes. These postural effects can become clinically important in critically ill patients. Currently there is debate in the scientific world about how gravity actually influences lung function, and how it interacts with other factors such as the anatomical structure of the airways and blood vessels of the lung. New technology developed by researchers at the University of Oxford now has the potential to help answer some of these questions. This device uses a technique called laser absorption spectroscopy to make measurements of breathing gases that are much more accurate than previous techniques - it is able to count the number of oxygen, carbon dioxide and water vapour molecules in and out while a person breathes. A non-invasive 15-minute breathing test with this technology provides information on the distributions of airflow and blood flow in the lungs, and it has been deployed successfully in the operating theatre and in intensive care units. This study aims to make comprehensive measurements of lung physiology under altered gravitational conditions and develop the technology and measurement techniques for possible future use in microgravity. This will include measurements of oxygen and carbon dioxide from the laser gas analyser (and measures of lung inhomogeneity obtained from these), lung mechanics and breathing drive.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 31, 2018
Est. primary completion date July 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- healthy volunteer who has provided informed consent

Exclusion Criteria:

- any significant medical problem, as documented extensively in the study ethics documentation.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High G acceleration on a long-arm human centrifuge
Gx (chest-to-back) and Gz (head-to-toe)

Locations

Country Name City State
United Kingdom Centre of Human and Aerospace Physiological Sciences London

Sponsors (4)

Lead Sponsor Collaborator
King's College London QinetiQ Ltd, UK Space Agency, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lung inhomogeneity index The lung inhomogeneity index is the standard deviation for the natural logarithm of the standardised lung compliance, equivalent to the standard deviation for the natural logarithm of the ratio between fractional lung compliance and fractional alveolar volume of the lung units.
It is determined using the respiratory data obtained by molecular flow sensing using the laser gas analyser.
Determined over a 15-minute multi-breath washout at 3 G on the centrifuge
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