NCT02905084

Brief Summary

The environment of the ICU and operating room allows the multi continuous monitoring of patients in critical situations. The physician anesthesiologist is working more and more in an environment where he receives a multitude of information from both the patient's medical history but also measured data in real time to its physiological situation. It is sometimes difficult for practitioners to consider all of the information by identifying a course of action. A decision support and a degree of automation can increase security along the lines of what has been observed in many processes and industries like aviation. The goal of this project is to establish initially a database of physiological parameters. We want to use patient data to model physiological processes in order to advance towards the creation of "physios" program,

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

September 6, 2016

Last Update Submit

September 13, 2016

Conditions

Patient Care in ICU

Outcome Measures

Primary Outcomes (1)

  • Correlation between high blood pressure measurement during the first 24h in ICU and number of patient alive at 28 days post ICU

    28 days

Eligibility Criteria

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

Patient in intensive care unit

You may qualify if:

  • Patient in intensive care unit ward

You may not qualify if:

  • Patient or familly refusing participating to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

  • Salah BOUSSEN, MD

    michelsalah.boussen@ap-hm.fr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salah Boussen, MD

CONTACT

michelsalah.boussen@ap-hm.fr

Study Design

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

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 19, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2020

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)