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

Not Applicable

Completed

• Conditions: Positive-Pressure Respiration, Intrinsic; Critically Ill Patients
• Interventions: Other: Dermal blood flow measurements

• Registration Number: NCT01794468
• Lead Sponsor: Rabin Medical Center

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

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 Timeline

• Study Start: 2003-06
• Primary Completion: 2005-04
• Study Completion: 2005-07
• Status Verified: 2013-02
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-15
• Last Update Submitted: 2013-02-15
• Study First Posted: 2013-02-18
• Last Update Posted: 2013-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

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

Exclusion Criteria

• Age < 18 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group-Dermal blood flow measurements	Dermal blood flow measurements	Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor

Primary Outcome Measures

Name	Time	Method
Dermal blood flow measurements	over an 8-hour period	DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.

Trial Locations

Locations (1)

ICU dep't , Rabin MC; 🇮🇱 Petah Tikva, Israel