Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-17 @ 7:36 PM
Study NCT ID:
NCT01794468
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2013-02-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
A New Monitor to Measure Dermal Blood Flow in Critically Ill Patients: a Preliminary Study
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MDBF-CIP
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: