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

Critically Ill Patients Clinical Trial

— MDBF-CIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794468
• Other study ID #: 3030
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: February 15, 2013
• Start date: June 2003
• Est. completion date: July 2005

Study information

• Verified date: February 2013
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years old

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Positive-Pressure Respiration, Intrinsic

Intervention

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.

Locations

Country	Name	City	State
Israel	ICU dep't , Rabin MC	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dermal blood flow measurements	DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.	over an 8-hour period	No