NCT02447731

Brief Summary

Study of the effects of sonic pressure oscillations on pulmonary gas exchange with added dead space.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

February 2, 2015

Last Update Submit

May 1, 2017

Conditions

Respiratory Failure

Keywords

respiratory insufficiency

Outcome Measures

Primary Outcomes (1)

  • Percent Improvement in PtcO2 & PtcCO2

    Sonic vibrations similar to human screaming should improve pulmonary gas diffusion by more than 5% in few seconds.

    1 month

Secondary Outcomes (1)

  • mL/min exhaled VCO2 and VO2

    1 month

Other Outcomes (1)

  • Percent improvement in lung diffusion capacity

    1 month

Study Arms (1)

Sonic Gas Exchange

Gas exchange rates in the lungs of subjects breathing through a mouthpiece will be compared with their gas exchange rates after addition of sound pressure vibrations into the supplied gas. 'Induction of sound waves in lungs by "sonic oscillator"' can be as loud as a human screaming or singing very loudly (about 95 dB). The effects of these pressure oscillations on gas exchange will be assessed using 3 tests as explained in the section under "detailed description".

Device: Induction of sound waves in lungs by "sonic oscillator"

Interventions

Induction of sound waves in lungs by "sonic oscillator"DEVICE

A device called sonic oscillator will add sonic waves to the inhaled gases while the subjects are going through 3 tests measuring the variations made in pulmonary functions induced by sound waves.

Also known as: Sonic Lung Ventilation
Sonic Gas Exchange

Eligibility Criteria

Age21 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young healthy adults of any gender.

You may qualify if:

  • Healthy male or female volunteers in the age group.

You may not qualify if:

  • Any acute or chronic cardiopulmonary disorder including a simple common cold.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Jonathan M. R. Jam, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2015

First Posted

May 19, 2015

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)