A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study (MDBF-CIP)
Primary Purpose
Positive-Pressure Respiration, Intrinsic, Critically Ill Patients
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dermal blood flow measurements
Sponsored by
About this trial
This is an interventional basic science trial for Positive-Pressure Respiration, Intrinsic focused on measuring Dermal blood flow, critically ill
Eligibility Criteria
Inclusion Criteria:
- All patients were ventilated and sedated during an 8-hour period of measurement
Exclusion Criteria:
- Age < 18 years old
Sites / Locations
- ICU dep't , Rabin MC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group-Dermal blood flow measurements
Arm Description
Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor
Outcomes
Primary Outcome Measures
Dermal blood flow measurements
DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.
Secondary Outcome Measures
Full Information
NCT ID
NCT01794468
First Posted
February 15, 2013
Last Updated
February 15, 2013
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01794468
Brief Title
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Acronym
MDBF-CIP
Official Title
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Positive-Pressure Respiration, Intrinsic, Critically Ill Patients
Keywords
Dermal blood flow, critically ill
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group-Dermal blood flow measurements
Arm Type
Experimental
Arm Description
Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor
Intervention Type
Other
Intervention Name(s)
Dermal blood flow measurements
Intervention Description
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 Outcome Measure Information:
Title
Dermal blood flow measurements
Description
DBF monitor - non-invasive method for detecting changes in perfusion in critically ill patients.
Time Frame
over an 8-hour period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients were ventilated and sedated during an 8-hour period of measurement
Exclusion Criteria:
Age < 18 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Cohen, Professor,MD
Organizational Affiliation
ICU dep't, Rabin MC,Petah Tikva, Israel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pierre Singer, Professor,MD
Organizational Affiliation
ICU dep't, Rabin MC,Petah Tikva, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICU dep't , Rabin MC
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
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A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
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