A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study (MDBF-CIP)

February 15, 2013 updated by: Pierre singer, Rabin Medical Center

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DBF, finger plethysmography and invasive mean arterial pressure (MAP) were recorded over an 8-hour period. DBF was measured using the I.S. MedTech DBF monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. Sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. Specificity was evaluated during stable states (minimal fluctuations of MAP and no active interventions applied or required). Data are expressed in terms of standard deviation (SD) and of the difference (SDD) between the MAP and each of the tested methods.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • ICU dep't , Rabin MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study group-Dermal blood flow measurements
Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor
Other: Dermal blood flow measurements
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermal blood flow measurements
Time Frame: over an 8-hour period
DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.
over an 8-hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Study Chair: Jonathan Cohen, Professor,MD, ICU dep't, Rabin MC,Petah Tikva, Israel
  • Principal Investigator: Pierre Singer, Professor,MD, ICU dep't, Rabin MC,Petah Tikva, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (ACTUAL)

April 1, 2005

Study Completion (ACTUAL)

July 1, 2005

Study Registration Dates

First Submitted

February 15, 2013

First Submitted That Met QC Criteria

February 15, 2013

First Posted (ESTIMATE)

February 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2013

Last Update Submitted That Met QC Criteria

February 15, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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