NCT01935427

Brief Summary

This study is designed to validate implementation of the CRI algorithm in the CypherOx CRI system. Healthy human subjects will undergo progressive reduction in central blood volume to the point of hemodynamic instability (defined by a precipitous fall in systolic blood pressure (SBP) below 70 mmHg and/or voluntary subject termination due to discomfort (such as sweating, nausea, or dizziness) to validate the following hypotheses: The CypherOx CRI system will A. Trend intravascular volume changes (hemorrhage) B. Trend stroke volume changes and C. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does not require calibration or being placed during normal physiological conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

August 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

August 28, 2013

Last Update Submit

March 4, 2015

Conditions

Hemorrhage

Keywords

Pulse OximeterStroke VolumeHemorrhagic shockCompensatory Reserve Index

Outcome Measures

Primary Outcomes (1)

  • 15 subjects must complete the LBNP trial

    15 subjects must complete the LBNP trial to 70mmHg negative pressure

    Up to 4 months

Study Arms (1)

Volunteer test subjects

Healthy volunteer with no cardiovascular disease

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy non-pregnant volunteers with no cardiovascular disease or other health issues.

You may qualify if:

  • Healthy nonsmoking normotensive (\<140/90) males or females.
  • Age 18 to 55 yr.
  • Normal clinical results from a Medical History and Physical form DD 2807-1
  • Military or civilian.
  • Documentation of a negative pregnancy test within 24 hours prior to each study period, if necessary.
  • Not obese, as defined by body mass index (BMI) \< 30, unless individual is athletic (BMI may not be the best method of assessing obesity in athletic individuals). BMI is calculated as the weight in kilograms divided by the square of the height in meters.

You may not qualify if:

  • (a) Age \<18 and \>55 years.
  • Individuals taking prescription drugs, non-prescription drugs or herbal medicines known to alter autonomic function unless cleared by the Medical Screener.
  • Subjects using prescription medications within 30 days before initiation of the experiments unless cleared by the Medical Screener.
  • Subjects with a history of alcohol or drug abuse which inhibits the subject's ability to complete this study.
  • Smokers.
  • Subjects with signs of cardiovascular abnormalities (e.g., hypertension (\> 140/90), autonomic dysfunction (Shy-Drager Syndrome, Bradbury-Eggleston syndrome, sinus arrhythmia, idiopathic orthostatic hypotension), fainting disorder, etc.).
  • Subjects with respiratory illnesses (e.g., asthma, Chronic Obstructive Pulmonary Disease, Reactive Airway Disease, etc.).
  • Subjects with a history of anaphylaxis.
  • Subjects with allergies to medications not cleared by the Medical Screener. Individuals reporting a history of pre-syncopal/syncopal episodes or orthostatic hypotension.
  • Subjects with a history or family history of abnormal blood clotting, clots in deep veins in the legs or pelvis, or blood clots to the lungs.
  • Individuals taking prescription medications for hypertension (high blood pressure). (l) Individuals with known or suspected abdominal hernias
  • Pregnancy, trying to become pregnant, or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Army Institute of Surgical Research

San Antonio, Texas, 78234-7767, United States

Location

MeSH Terms

Conditions

HemorrhageShock, Hemorrhagic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Victor A Convertino, Ph.D.

    US Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 5, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)