Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR) (Cohorte-SRPR)

March 27, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) .

Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their hospitalization from hospital reports or call of the attending physician.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For one year, all patients, adults and children hospitalized in a post-intensive care rehabilitation unit (SRPR) of Ile de France and Rouen will be offered to participate in the SRPR Cohort in order to have a completeness of data on a new practice.

The study of these data will make it possible to know the future of the patients and to establish criteria prior to the admission in the SRPR which could make it possible to predict this future and to select the patients as well as possible. It will also make it possible to know the impact of care on the outcome of patients at discharge, at 28 days, 90 days and 1 year of their admission to SRPR to improve practices.

This research will focus on the collection of data from patients' medical records. General information about their stay in the intensive care unit - including the patient's ventilatory status - will be collected upon arrival at the SRPR units, during their stay (weekly follow-up), at the exit of the SRPR, at D28, and in the longer term. (J90 and J365 of the entry into the SRPR unit) where will be listed more comprehensive data with, in addition to general information, data on nutritional, neurological, neuromuscular, respiratory and biological hemodynamic assessments will be collected.

In addition to the common data base, each type of SRPR (respiratory and pediatric neurology) will collect data that is specific to its specialty.

Study Type

Observational

Enrollment (Anticipated)

1000

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
      • Beaumont-sur-Oise, France, 95260
      • Briis-sous-Forges, France, 91640
        • Not yet recruiting
        • Centre Hospitalier de Bligny
        • Contact:
      • Clamart, France, 92190
        • Not yet recruiting
        • Hôpital d'Instruction des Armées - Percy
        • Contact:
          • David ROGEZ, Dr
      • Férolles-Attilly, France, 77150
      • Garches, France, 92380
        • Not yet recruiting
        • Hôpital Raymond Poincaré - SRPR pédiatrique
        • Contact:
      • Garches, France, 92380
        • Not yet recruiting
        • Hôpital Raymond Poincaré de Garches - SRPR neurologique
        • Contact:
      • Le Kremlin-Bicêtre, France, 94270
      • Paris, France, 75013
      • Paris, France, 75014
      • Rouen, France, 76000

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen

Description

Inclusion Criteria:

  • Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen

Exclusion Criteria:

  • Refusal of access to the data by the patient or the designated trusted person or the holder (s) of parental authority (pediatric population)

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR)
Other: Data gathering
Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilation status of patients discharged from SRPR
Time Frame: 28 days
Describe the ventilatory status of patients hospitalized in SRPR at the SRPR exit: during the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status assessed by the functional independence measurement scale (MIF) at entry to the SRPR and weekly follow-up during the stay and discharge of the SRPR, at discharge from the hospital, at Day 28, Day 90 and at 1 year.
Time Frame: one year
Describe the clinico-biological characteristics of patients prior to admission to SRPRs and their future in order to better select them.
one year
Vital status at the exit of the SRPR at Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
Time Frame: Between the exit of the SRPR and up to one year after entry into the SRPR unit
The only one parameters that we will measure will be vital status: alive or not?
Between the exit of the SRPR and up to one year after entry into the SRPR unit
Ventilatory status at discharge from the hospital, Day 28, Day 90 and at 1 year. The starting point is the entry into the SRPR unit.
Time Frame: Between the exit of the SRPR and up to one year after entry into the SRPR unit
During the week before the evaluation, does the patient use at least one time: invasive or noninvasive ventilation?
Between the exit of the SRPR and up to one year after entry into the SRPR unit
Length of stay in intensive care unit, SRPR and hospital
Time Frame: one year
one year
Evaluation of swallowing of patients
Time Frame: one day
Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
one day
Evaluation of nutrition of patients
Time Frame: one day
Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
one day
Evaluation of nutritional status of patients
Time Frame: one day
Evaluate by clinical data recorded in the medical file: weight in kilograms, height in meters and a combined BMI= weight/height in kg/m^2) and measurement of albumin (g/l) and measurement of prealbuminemia (g/l) at upon entry into SRPR service.
one day

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Alexandre DEMOULE, Pr, Hôpital Pitié-Salpêtrière - AP-HP

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 (Actual)

March 15, 2019

Primary Completion (Anticipated)

March 15, 2025

Study Completion (Anticipated)

August 30, 2025

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • NI17008J
  • 2018-A00743-52 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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