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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Israel1 site
  • Rambam Health Care Campus

    Haifa, 3109601

Other trials in Israel

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

  1. 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.
  2. 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.
  3. 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.

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.

  1. 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)
  1. 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

  2. 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.

  1. First posted5 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionFeb 2017
  4. Study completionDec 2017

Resources

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)
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

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.

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