Intensive Care Patients on a VentilatorTimerNCT01735292
Safety of the Automatic Respiration Transfer System- Timer
A study testing Automatic Respiration Transfer System- Timer in people with Intensive Care Patients on a Ventilator, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Intensive Care Patients on a Ventilator
- What is being tested?
- Automatic Respiration Transfer System- Timer
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ventilated patients with informed consent
Who cannot join
- Non- ventilated patients
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, Israel, 93588
Charles Sprung, MD
About this study
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.
- Conditions
- Intensive Care Patients on a Ventilator
- Being tested
- Automatic Respiration Transfer System- Timer
- Keywords
- Ventilation, timer
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic Respiration Transfer System- TimerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Automatic Respiration Transfer System- Timer
Number of Adverse Events
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Patients on a VentilatorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Responsible party
- Principal investigator, SPRUNG CHARLES, Hadassah Medical Organization
- Investigators
- Charles Sprung, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735292
- Sponsor's protocol ID
- 0209-12-HMO
- Acronym
- Timer
- Status last verified
- Nov 2012
- First submitted
- 19 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of the Automatic Respiration Transfer System- Timer
- ClinicalTrials.gov ID
- NCT01735292
- Acronym / sponsor ID
- Timer / 0209-12-HMO
- Conditions
- Intensive Care Patients on a Ventilator
- Keywords
- Ventilation, timer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Ventilated patients with informed consent
Key exclusion criteria (1 listed)
- Non- ventilated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automatic Respiration Transfer System- Timer | Device | – |
Primary outcome
Safety of the Automatic Respiration Transfer System- Timer
Time frame: one year
Number of Adverse Events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Sprung, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automatic Respiration Transfer System- Timer in people with Intensive Care Patients on a Ventilator, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles Sprung, MD (97226778060, charless@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the Automatic Respiration Transfer System- Timer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012; AzTrials last refreshed its copy on 30 Oct 2026.