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Safety of the Automatic Respiration Transfer System- Timer (Timer)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by SPRUNG CHARLES, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01735292
First Posted: November 28, 2012
Last Update Posted: November 28, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Shaare Zedek Medical Center
Information provided by (Responsible Party):
SPRUNG CHARLES, Hadassah Medical Organization
  Purpose
The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to have their ventilator placed on a timer which at a specific time in the future stops the ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes during the use of the timer with the regular ventilator. In addition, we will evaluate whether the timer stops the ventilator and switches to CPAP at the designated time.

Condition Intervention
Intensive Care Patients on a Ventilator Device: Automatic Respiration Transfer System- Timer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Safety of the Automatic Respiration Transfer System- Timer

Further study details as provided by SPRUNG CHARLES, Hadassah Medical Organization:

Primary Outcome Measures:
  • Safety of the Automatic Respiration Transfer System- Timer [ Time Frame: one year ]
    Number of Adverse Events


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ventilated patients with informed consent

Exclusion Criteria:

  • Non- ventilated patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735292


Contacts
Contact: Charles Sprung, MD 97226778060 charless@ekmd.huji.ac.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 93588
Principal Investigator: Charles Sprung, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Shaare Zedek Medical Center
Investigators
Principal Investigator: Charles Sprung, MD Hadassah Medical Organization
  More Information

Responsible Party: SPRUNG CHARLES, Director, General Intensive Care Unit, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01735292     History of Changes
Other Study ID Numbers: 0209-12-HMO
First Submitted: November 19, 2012
First Posted: November 28, 2012
Last Update Posted: November 28, 2012
Last Verified: November 2012

Keywords provided by SPRUNG CHARLES, Hadassah Medical Organization:
Ventilation, timer