Safety of the Automatic Respiration Transfer System- Timer | NCT01735292

Studies
Safety of the Automatic Respiration Transfer System- Timer

NCT01735292

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Nov 28, 2012Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Intensive Care Patients on a Ventilator

Interventions

Automatic Respiration Transfer System- Timer

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Nov 19, 2012

First Submission Date that Met QC Criteria

Nov 23, 2012

First Posted Date

Nov 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2012

Last Update Posted Date

Nov 28, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

SPRUNG CHARLES, Director, General Intensive Care Unit, Hadassah Medical OrganizationPrincipal Investigator

Lead Sponsor

Hadassah Medical OrganizationOTHER

Collaborators

Name	Class
Shaare Zedek Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Automatic Respiration Transfer System- Timer	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of the Automatic Respiration Transfer System- Timer	Number of Adverse Events	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ventilated patients with informed consent

Exclusion Criteria:

Non- ventilated patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charles Sprung, MD	Contact	97226778060		charless@ekmd.huji.ac.il

Overall Officials

Name	Affiliation	Role
Charles Sprung, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem	Israel	93588	Israel

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided