NCT04433325

Brief Summary

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.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

June 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1 month

First QC Date

June 12, 2020

Last Update Submit

June 15, 2020

Conditions

Keywords

Medical transport by train

Outcome Measures

Primary Outcomes (1)

  • number of death

    to evaluate mortality

    at Intensive Care Units discharge, an average of 1 months

Secondary Outcomes (7)

  • number of infections

    from date of admission until Intensive Care Units discharge, assessed up to 1 months

  • number of days of mechanical ventilation

    from date of admission until Intensive Care Units discharge, assessed up to 1 months

  • number of days of sedation

    from date of admission until Intensive Care Units discharge, assessed up to 1 months

  • number of days of use of neuromuscular blocking agents

    from date of admission until Intensive Care Units discharge, assessed up to 1 months

  • number of days of vasopressor use

    from date of admission until Intensive Care Units discharge, assessed up to 1 months

  • +2 more secondary outcomes

Study Arms (2)

Patients transferred

Patients transferred from Paris's Intensive Care Units

Patients not transferred

Patients admitted in Intensive Care Units with no transfer from Paris

Eligibility Criteria

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

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

You may qualify if:

  • Age \> 18 years
  • COVID-19 positive patients admitted in Intensive Care Unit between 15/03/2020 and 15/04/2020
  • Regarding case group : Patients transferred from Paris's ICU
  • Regarding case control group : Patients admitted in ICU with no transfer from Paris

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Poitiers

Poitiers, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Benoît Painvin

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 16, 2020

Study Start

June 1, 2020

Primary Completion

July 1, 2020

Study Completion

September 1, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations