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Advanced Gravitational Physiology the Lung Under High-G Acceleration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463096
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
University of Oxford
QinetiQ Ltd
UK Space Agency
Information provided by (Responsible Party):
King's College London

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Physiology Other: High G acceleration on a long-arm human centrifuge Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Advanced Gravitational Physiology the Lung Under High-G Acceleration
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : July 31, 2018
Actual Study Completion Date : July 31, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Centrifuge study
High G acceleration on a long-arm human centrifuge
 Other: High G acceleration on a long-arm human centrifuge
Gx (chest-to-back) and Gz (head-to-toe)


Outcome Measures
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Primary Outcome Measures :
  1. Lung inhomogeneity index [ Time Frame: Determined over a 15-minute multi-breath washout at 3 G on the centrifuge ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer who has provided informed consent

Exclusion Criteria:

  • any significant medical problem, as documented extensively in the study ethics documentation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463096


Locations
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United Kingdom
Centre of Human and Aerospace Physiological Sciences
London, United Kingdom, SE11UL
Sponsors and Collaborators
King's College London
University of Oxford
QinetiQ Ltd
UK Space Agency
Investigators
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Principal Investigator: Thomas G Smith King's College London
More Information
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03463096    
Other Study ID Numbers: SP801
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
respiratory
physiology
gravity