COVID-19 Critically Ill Patients' Evolution After Medical Transport by Train From Paris Intensive Care Units to West of France Intensive Care Units (TOCCIP)

June 15, 2020 updated by: Rennes University Hospital
Since early 2020, France knows a sanitary crisis with a massive influx of COVID-19 patients admitted in Intensive Care Units (ICU). It led to a saturation of the French health system, especially in some geographic areas such as East of France or Paris region. Therefore, authorities decided to transfer some critically ill patients from these crowded ICUs to less busy regional ICUs. it was done for the first time by medical train transportation. Knowing that the investigators lack experience regarding this type of medical evacuation, regarding the high number of transferred patients, with such a logistic effort, the investigators decided to study this phase of the COVID-19 sanitary crisis in order to draw a feedback. So far, there are no data in the literature regarding this topic.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Poitiers, France
        • CHU Poitiers
        • Contact:
          • Arnaud THILLES
      • Tours, France
        • CHU Tours
        • Contact:
          • Stéphane ERHMANN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID-19 positive patients admitted in Intensive Care Unit between 15/03/2020 and 15/04/2020

Description

Inclusion Criteria:

  • Age > 18 years
  • COVID-19 positive patients admitted in Intensive Care Unit between 15/03/2020 and 15/04/2020
  • Patients (or legal representative) with no opposition to inclusion in medical research protocol
  • Regarding case group : Patients transferred from Paris's ICU
  • Regarding case control group : Patients admitted in ICU with no transfer from Paris

Exclusion Criteria:

- > 18 years under legal protection and patients with liberty restriction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients transferred
Patients transferred from Paris's Intensive Care Units
Patients not transferred
Patients admitted in Intensive Care Units with no transfer from Paris

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of death
Time Frame: at Intensive Care Units discharge, an average of 1 months
to evaluate mortality
at Intensive Care Units discharge, an average of 1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of infections
Time Frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
to evaluate morbidity
from date of admission until Intensive Care Units discharge, assessed up to 1 months
number of days of mechanical ventilation
Time Frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
from date of admission until Intensive Care Units discharge, assessed up to 1 months
number of days of sedation
Time Frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
from date of admission until Intensive Care Units discharge, assessed up to 1 months
number of days of use of neuromuscular blocking agents
Time Frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
from date of admission until Intensive Care Units discharge, assessed up to 1 months
number of days of vasopressor use
Time Frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
from date of admission until Intensive Care Units discharge, assessed up to 1 months
number of days in Intensive Care Units
Time Frame: from date of admission until Intensive Care Units discharge, assessed up to 1 months
from date of admission until Intensive Care Units discharge, assessed up to 1 months
number of days in hospital
Time Frame: from date of admission until hospital discharge, assessed up to 1 months
from date of admission until hospital discharge, assessed up to 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Benoît Painvin, CHU Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_3091_TOCCIP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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