Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01735292
Other study ID # 0209-12-HMO
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 19, 2012
Last updated November 23, 2012
Start date January 2013
Est. completion date January 2014

Study information

Verified date November 2012
Source Hadassah Medical Organization
Contact Charles Sprung, MD
Phone 97226778060
Email charless@ekmd.huji.ac.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria:

- Ventilated patients with informed consent

Exclusion Criteria:

- Non- ventilated patients

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms

  • Intensive Care Patients on a Ventilator

Intervention

Device:
Automatic Respiration Transfer System- Timer


Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (2)

Lead Sponsor Collaborator
Hadassah Medical Organization Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of the Automatic Respiration Transfer System- Timer Number of Adverse Events one year Yes