Safety of the Automatic Respiration Transfer System- Timer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Hadassah Medical Organization
Sponsor:
Collaborator:
Shaare Zedek Medical Center
Information provided by (Responsible Party):
SPRUNG CHARLES, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01735292
First received: November 19, 2012
Last updated: November 23, 2012
Last verified: November 2012
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Safety of the Automatic Respiration Transfer System- Timer

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Safety of the Automatic Respiration Transfer System- Timer [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ventilated patients with informed consent

Exclusion Criteria:

  • Non- ventilated patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 19, 2012
Last Updated: November 23, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Ventilation, timer

ClinicalTrials.gov processed this record on October 23, 2014