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Not yet recruiting NCT05542329

Efficiency of a Telemedicine-based Follow-up on for the Medical Management of Patients Leaving the Intensive Care Unit

No phase Interventional Care After Going to Intensive Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Monitoring by Tele-Medecine.
Who it may be relevant to
Registry conditions: Care After Going to Intensive Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Patients surviving to a stay in intensive care unit (ICU) are likely to require specific care and follow-up after their ICU stay, in order to manage the serious illness at the origin of the ICU stay and any sequelae, but also to adapt the treatments and prevent new complications. At present, there is no specific care chain after ICU. In order to meet this need, we propose the implementation of a care chain integrating telemedicine at home. We compare the current system (lack of specific follow-up) to follow-up by telemedicine at home.

Interventions

  • Device Monitoring by Tele-Medecine
    Monitoring by Tele-Medecine

Primary outcome measures

  • Evaluate the medico-economic of telemedicine monitoring [Time frame: 12 month]

Eligibility criteria

Inclusion criteria

  • Adult patient ≥ 18 years old
  • Patient admitted to ICU
  • Stay in intensive care > 48h
  • Patient having benefited from at least one organ support during the ICU stay: invasive or non-invasive ventilation (including nasal high-flow oxygen therapy), inotropic or vasopressor support, renal replacement therapy)
  • Understanding of the French language
  • Patient or entourage able to carry out the measures proposed by telemedicine
  • Subject affiliated to a social health insurance scheme
  • Subject having signed a consent form

Exclusion criteria

  • Subject under guardianship or curatorship
  • Pregnancy / lactation
  • Voluntary drug poisoning

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 4 centers
  • Service de Réanimation Médicale - CH Dijon — Dijon
  • Service de Réanimation Médicale - CH Mulhouse — Mulhouse
  • Service de Réanimation Médicale - CHRU Nancy - France — Nancy
  • Service de Médecine Intensive - Réanimation / CHU Strasbourg - France — Strasbourg

Identifiers

NCT: NCT05542329 · 8940

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗