NCT01746576

Brief Summary

The purpose of this study is to determine whether analysis of near infrared absorbance signals that occur at different frequencies might provide information about the difference in oxygen saturation between arterial and venous blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 16, 2014

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

October 29, 2012

Last Update Submit

April 15, 2014

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

  • Estimated venous oxygen saturation

    Oxygen saturation will be calculated from the five minute period of time prior to use of the impedance threshold device (0-4 mins), and then again in the 2 minute period after the impedance threshold device is applied (5-6 mins)

    From 5 to 6:59 minutes after applying the impedance threshold device

Study Arms (1)

All

OTHER

All subjects will undergo spontaneous ventilation through an impedance threshold device and ScvO2 will be recorded before and after

Other: Use of impedance threshold device during spontaneous ventilation

Interventions

Use of impedance threshold device during spontaneous ventilationOTHER
All

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult 18-65 years of age

You may not qualify if:

  • Dilated cardiomyopathy
  • Congestive heart failure
  • Pulmonary hypertension
  • Severe aortic stenosis
  • Flail chest
  • Chest pain
  • Shortness of breath

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Thiele RH, Tucker-Schwartz JM, Lu Y, Gillies GT, Durieux ME. Transcutaneous regional venous oximetry: a feasibility study. Anesth Analg. 2011 Jun;112(6):1353-7. doi: 10.1213/ANE.0b013e3182166a26.

    PMID: 21613200BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 29, 2012

First Posted

December 11, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 16, 2014

Record last verified: 2012-12

Locations

US(1)