NCT03850340

Brief Summary

This study will be a retrospective, observational analysis study of ventilator patients in the Medical Surgical Intensive Care unit being monitored via automated near real-time ventilator analytical software.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Status
unknown

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

January 29, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

January 29, 2019

Last Update Submit

February 20, 2019

Conditions

Ventilator Associated Events

Keywords

Ventilator Associated ConditionsInfection Related Ventilator Associated ConditionsProbable Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Incidence of Ventilator Associated Events

    Measure of the number of occurrences of ventilator associated events

    03/01/2014 until 02/28/2019

Eligibility Criteria

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

includes all mechanically ventilated patients in the study center's Medical-Surgical Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.

You may qualify if:

  • includes all mechanically ventilated patients in the Intensive Care Unit above the age of 18 years of age and who were mechanically ventilated for ≥ 3 days.

You may not qualify if:

  • any patients under the age of 18 or mechanically ventilated for \< 3days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager, Pulmonary Medicine

Study Record Dates

First Submitted

January 29, 2019

First Posted

February 21, 2019

Study Start

March 31, 2019

Primary Completion

November 30, 2019

Study Completion

December 31, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02