NCT02379884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
619

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

February 22, 2015

Last Update Submit

April 22, 2018

Conditions

Respiratory Arrest

Keywords

Mechanical ventilationElderlyMortalityHealth services

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Data will be obtained from the Israel National Population Registry

    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

    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

    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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • Mechanical ventilation
  • Males and females
  • Age over 18 years
  • Admitted to internal medicine wards or medical intensive care unit

You may not qualify if:

  • Younger than 18 years
  • Surgical and trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

MeSH Terms

Conditions

Apnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tzvi Dwolatzky, MD MBBCh

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

April 24, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)