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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 Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Shaare Zedek Medical Center
Information provided by (Responsible Party):
SPRUNG CHARLES, Hadassah Medical Organization Identifier:
First received: November 19, 2012
Last updated: November 23, 2012
Last verified: November 2012
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)

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

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 identifier: NCT01735292

Hadassah Medical Organization
Jerusalem, Israel, 93588
Sponsors and Collaborators
Hadassah Medical Organization
Shaare Zedek Medical Center
Principal Investigator: Charles Sprung, MD Hadassah Medical Organization
  More Information

Responsible Party: SPRUNG CHARLES, Director, General Intensive Care Unit, Hadassah Medical Organization 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 processed this record on January 14, 2017