NCT03592290

Brief Summary

To monitor the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Nov 2017Jan 2027

Study Start

First participant enrolled

November 15, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

9.1 years

First QC Date

June 13, 2018

Last Update Submit

January 15, 2026

Conditions

HypovolemiaHemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Identify the most robust site for monitoring hypovolemia utilizing pulse oximeter waveforms.

    Data will be summarized using mean (SD) for normally distributed data, median (interquartile range) for non-normal data. linear regression method will be used to model the changes of our dependent variable from baseline during blood loss.

    2 years

Secondary Outcomes (1)

  • Examine the relationship between central hemodynamic changes (cardiac output) with changes in respiratory variability of PPG waveforms collected from different sites during hypovolemia and fluid resuscitation

    2 years

Interventions

Lower body negative pressureDIAGNOSTIC_TEST

We will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers aged 20-45 with no history of heart disease, diabetes, or hypertension. Pregnant women will be excluded.

You may qualify if:

  • \* Healthy volunteers aged 20-45 with

You may not qualify if:

  • Pregnant women
  • Under 20 years of age
  • Subjects with coronary artery disease, diabetes, epilepsy and hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John B. Pierce Laboratory

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Hypovolemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aymen Alian, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aymen Alian, MD

CONTACT

203-785-2802aymen.alian@yale.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 19, 2018

Study Start

November 15, 2017

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

US(1)