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Pneumatic Sleeves and Congestive Heart Failure (Sleeves-Bickel)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intermittent Sequntial Pnumatic Compression Leg Sleeves
Sponsored by
Western Galilee Hospital-Nahariya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Congestive Heart Failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CHF (as clinically evaluated and asessed by TTE)
  • Gave informed consent
  • NYHA Class II-III
  • LVEF equal or less than 40%

Exclusion Criteria:

  • Patients who could not sign informed consent
  • NYHA Class IV
  • Oxygen saturation less than 90% under room air

Sites / Locations

  • Western Galilee Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pneumatic Sleeves

Congestive Heart Failure Patients

Arm Description

Outcomes

Primary Outcome Measures

Cardiac Output

Secondary Outcome Measures

Systemic vascular resistance

Full Information

First Posted
September 9, 2012
Last Updated
September 19, 2012
Sponsor
Western Galilee Hospital-Nahariya
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1. Study Identification

Unique Protocol Identification Number
NCT01691417
Brief Title
Pneumatic Sleeves and Congestive Heart Failure
Acronym
Sleeves-Bickel
Official Title
The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Galilee Hospital-Nahariya

4. Oversight

5. Study Description

Brief Summary
Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Pneumatic Sleeves
Arm Type
Experimental
Arm Title
Congestive Heart Failure Patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intermittent Sequntial Pnumatic Compression Leg Sleeves
Primary Outcome Measure Information:
Title
Cardiac Output
Secondary Outcome Measure Information:
Title
Systemic vascular resistance
Other Pre-specified Outcome Measures:
Title
Stroke volume

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CHF (as clinically evaluated and asessed by TTE) Gave informed consent NYHA Class II-III LVEF equal or less than 40% Exclusion Criteria: Patients who could not sign informed consent NYHA Class IV Oxygen saturation less than 90% under room air
Facility Information:
Facility Name
Western Galilee Hospital
City
Nahariya
ZIP/Postal Code
22100
Country
Israel

12. IPD Sharing Statement

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Pneumatic Sleeves and Congestive Heart Failure

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