Respiratory ArrestVentWiseNCT02379884
Mechanical Ventilation in Internal Medicine Elderly Patients - Choosing Wisely
An observational study of Respiratory Arrest, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
This is a prospective observational study evaluating all patients requiring mechanical ventilation. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Arrest
- How many people
- 619 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Dec 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients requiring mechanical ventilation over the study period. Inclusion criteria: Males and females Age over 18 years Admitted to internal medicine wards or medical intensive care unit
Who may be able to join
- Mechanical ventilation
- Males and females
- Age over 18 years
- Admitted to internal medicine wards or medical intensive care unit
Who cannot join
- Younger than 18 years
- Surgical and trauma patients
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective observational study evaluating all patients requiring mechanical ventilation. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored.
Read the detailed description
Background The aging of the population associated with increased morbidity, on one hand, and technological advances providing life-sustaining treatments on the other, resulted in an increased number of mechanically ventilated patients in Internal Medicine wards. In a previous study the investigators found that about half of the hospitalization days in intermediate care units in Internal Medicine wards were utilized by older patients at the end of life. The mortality at 6 months from the time of admission was greater than 70%, unrelated to the type of treatment. The majority of the elderly patients surviving the acute stage were transferred to chronic long-term care hospitals. The Public Health System in Israel invests costly resources in providing care to mechanically ventilated patients in both acute and chronic care settings, in spite of unproved benefit on the quality of life and on life expectancy.
Aims of the study
- Identification of patients and the factors affecting the decision-making process and outcome in mechanically ventilated patients in Internal Medicine wards in acute care hospitals.
- Development of a predictive model to classifying mechanically ventilated patients by outcome on the basis of patient characteristics on admission and the factors involved in decision-making.
- Assessment of medical resource investment according to the study model groups.
Study hypothesis Identification of parameters predicting better outcome and potential for rehabilitation in elderly mechanically ventilated internal medicine patients, versus patients with poorer outcome who would need palliative care.
Methods The study is a prospective observational study carried out in five Internal Medicine wards and the Medical Intensive Care Unit at the Rambam Health Care Campus in Haifa, Israel. All patients requiring mechanical ventilation will be included. Patients' medical and demographic data will be obtained from the hospital computerized record system. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored. Mortality at 6 months will be obtained from the Israel National Population Registry. Descriptive statistical analysis will be performed, and multivariate logistic regression analysis will be applied to identify variables contributing to the need for ventilation and outcome.
Importance of the study The approval of the 2005 Dying Patient Act in Israel, allowed for withholding of certain life-sustaining interventions at end of life. However, once an intervention such as mechanical ventilation has been commenced, the Law does not permit its withdrawing, making the decision to ventilate a patient irreversible. There is thus a clear need to improve the decision-making process related to undertaking mechanical ventilation in elderly internal medicine patients. In addition, the investigators believe that the study will highlight the issue and bring the policy makers to the establishing practical tools for health care professionals. The investigators also hope that the study will incite the general public attention to address the issue of advanced directives regarding undergoing invasive treatments such as mechanical ventilation at end of life. Finally, the investigators consider that adoption of a more evidence-based approach to undertaking mechanical ventilation, and consideration of patients' advanced directives, by health care providers in both community and in-patient settings, will lead to a better utilization of health resources and improvement of end of life of care.
- Conditions
- Respiratory Arrest
- Keywords
- Mechanical ventilation, Elderly, Mortality, Health services
- Medical subject headings
- Apnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Data will be obtained from the Israel National Population Registry
Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 6 months
Secondary outcomes (2)
Length of acute hospital stay
Data will be obtained from the acute care hospital computerized record system
Measured: From date of randomization until the date of first documented discharge from the acute care hospital to the community or to a long-term care institution, assessed up to 6 months
Ongoing medical and nursing care in a long term care institution
Data will be obtained from the acute care hospital computerized record system
Measured: From date of randomization until the date of first documented discharge from the acute care hospital to a long-term care institution, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Israel National Institute for Health Policy and Health Services Research
- Responsible party
- Sponsor
- Investigators
- Tzvi Dwolatzky, MD MBBCh, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379884
- Sponsor's protocol ID
- 0399-14-RMB CTIL
- Acronym
- VentWise
- Status last verified
- Apr 2018
- First submitted
- 22 Feb 2015
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation in Internal Medicine Elderly Patients - Choosing Wisely
- ClinicalTrials.gov ID
- NCT02379884
- Acronym / sponsor ID
- VentWise / 0399-14-RMB CTIL
- Conditions
- Respiratory Arrest
- Keywords
- Mechanical ventilation, Elderly, Mortality, Health services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Israel National Institute for Health Policy and Health Services Research
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Mar 2015 (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.
This is a prospective observational study evaluating all patients requiring mechanical ventilation. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored.
Detailed description
Background The aging of the population associated with increased morbidity, on one hand, and technological advances providing life-sustaining treatments on the other, resulted in an increased number of mechanically ventilated patients in Internal Medicine wards. In a previous study the investigators found that about half of the hospitalization days in intermediate care units in Internal Medicine wards were utilized by older patients at the end of life. The mortality at 6 months from the time of admission was greater than 70%, unrelated to the type of treatment. The majority of the elderly patients surviving the acute stage were transferred to chronic long-term care hospitals. The Public Health System in Israel invests costly resources in providing care to mechanically ventilated patients in both acute and chronic care settings, in spite of unproved benefit on the quality of life and on life expectancy.
Aims of the study
- Identification of patients and the factors affecting the decision-making process and outcome in mechanically ventilated patients in Internal Medicine wards in acute care hospitals.
- Development of a predictive model to classifying mechanically ventilated patients by outcome on the basis of patient characteristics on admission and the factors involved in decision-making.
- Assessment of medical resource investment according to the study model groups.
Study hypothesis Identification of parameters predicting better outcome and potential for rehabilitation in elderly mechanically ventilated internal medicine patients, versus patients with poorer outcome who would need palliative care.
Methods The study is a prospective observational study carried out in five Internal Medicine wards and the Medical Intensive Care Unit at the Rambam Health Care Campus in Haifa, Israel. All patients requiring mechanical ventilation will be included. Patients' medical and demographic data will be obtained from the hospital computerized record system. Data will be gathered regarding the events prior to ventilation and the indication for mechanical ventilation. In-hospital and post-admission outcome will be monitored. Mortality at 6 months will be obtained from the Israel National Population Registry. Descriptive statistical analysis will be performed, and multivariate logistic regression analysis will be applied to identify variables contributing to the need for ventilation and outcome.
Importance of the study The approval of the 2005 Dying Patient Act in Israel, allowed for withholding of certain life-sustaining interventions at end of life. However, once an intervention such as mechanical ventilation has been commenced, the Law does not permit its withdrawing, making the decision to ventilate a patient irreversible. There is thus a clear need to improve the decision-making process related to undertaking mechanical ventilation in elderly internal medicine patients. In addition, the investigators believe that the study will highlight the issue and bring the policy makers to the establishing practical tools for health care professionals. The investigators also hope that the study will incite the general public attention to address the issue of advanced directives regarding undergoing invasive treatments such as mechanical ventilation at end of life. Finally, the investigators consider that adoption of a more evidence-based approach to undertaking mechanical ventilation, and consideration of patients' advanced directives, by health care providers in both community and in-patient settings, will lead to a better utilization of health resources and improvement of end of life of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients requiring mechanical ventilation over the study period. Inclusion criteria: Males and females Age over 18 years Admitted to internal medicine wards or medical intensive care unit
Key inclusion criteria (4 listed)
- Mechanical ventilation
- Males and females
- Age over 18 years
- Admitted to internal medicine wards or medical intensive care unit
Key exclusion criteria (2 listed)
- Younger than 18 years
- Surgical and trauma patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 6 months
Data will be obtained from the Israel National Population Registry
2 secondary outcomes
Length of acute hospital stay
Time frame: From date of randomization until the date of first documented discharge from the acute care hospital to the community or to a long-term care institution, assessed up to 6 months
Ongoing medical and nursing care in a long term care institution
Time frame: From date of randomization until the date of first documented discharge from the acute care hospital to a long-term care institution, assessed up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Respiratory Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
Recruiting
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
Cardiac Arrest, Out-Of-Hospital, Hypothermia, Induced
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.
Tzvi Dwolatzky, MD MBBCh principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Arrest, run by Rambam Health Care Campus 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 24 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 6 months). 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 24 Apr 2018.