Advanced Gravitational Physiology the Lung Under High-G Acceleration

September 24, 2018 updated by: King's College London
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE11UL
        • Centre of Human and Aerospace Physiological Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteer who has provided informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Determined over a 15-minute multi-breath washout at 3 G on the centrifuge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

University of Oxford
QinetiQ Ltd
UK Space Agency

Investigators

  • Principal Investigator: Thomas G Smith, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2018

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

July 31, 2018

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SP801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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