A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study

NCT ID: NCT01794468

Last Updated: 2013-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Positive-Pressure Respiration, Intrinsic Critically Ill Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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study group-Dermal blood flow measurements

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

Group Type EXPERIMENTAL

Dermal blood flow measurements

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pierre singer

Professor , MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Cohen, Professor,MD

Role: STUDY_CHAIR

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

Pierre Singer, Professor,MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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ICU dep't , Rabin MC

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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3030

Identifier Type: -

Identifier Source: org_study_id

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