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OpenTrials
Completed

NCT Number: NCT01794468

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

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICU dep't , Rabin MC

Petah Tikva, 49100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age < 18 years old

Treatment and study plan

Dermal blood flow measurements

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Acronym: MDBF-CIP

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Feb 18, 2013
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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