NCT01794468

Brief Summary

Background: Conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs. Study Objectives: To assess the efficacy of a non-invasive, dermal blood flow (DBF) monitor in detecting changes in perfusion in critically ill patients. Preliminary Study Study Population: critically ill patients in a general ICU

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

February 15, 2013

Last Update Submit

February 15, 2013

Conditions

Positive-Pressure Respiration, IntrinsicCritically Ill Patients

Keywords

Dermal blood flowcritically ill

Outcome Measures

Primary Outcomes (1)

  • Dermal blood flow measurements

    DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.

    over an 8-hour period

Study Arms (1)

study group-Dermal blood flow measurements

EXPERIMENTAL

Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor

Other: Dermal blood flow measurements

Interventions

Dermal blood flow measurementsOTHER

Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor (I.S. MedTech, Israel), which consists of a skin probe and a measuring and control feedback unit.

study group-Dermal blood flow measurements

Eligibility Criteria

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

You may qualify if:

  • All patients were ventilated and sedated during an 8-hour period of measurement

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU dep't , Rabin MC

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Positive-Pressure Respiration, IntrinsicCritical Illness

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Cohen, Professor,MD

    ICU dep't, Rabin MC,Petah Tikva, Israel

    STUDY CHAIR

  • Pierre Singer, Professor,MD

    ICU dep't, Rabin MC,Petah Tikva, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor , MD

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 18, 2013

Study Start

June 1, 2003

Primary Completion

April 1, 2005

Study Completion

July 1, 2005

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

IL(1)