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

Recruiting

• Conditions: Hospitalization in a Post-Resuscitation Rehabilitation Care Units
• Interventions: Other: Data gathering

• Registration Number: NCT03768700
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2019-03-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28
• Primary Completion: 2025-03-15
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	Data gathering	Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR)

Primary Outcome Measures

Name	Time	Method
Ventilation status of patients discharged from SRPR	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?

Secondary Outcome Measures

Name	Time	Method
Length of stay in intensive care unit, SRPR and hospital	one year
Evaluation of nutrition of patients	one day	Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
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.	one year	Describe the clinico-biological characteristics of patients prior to admission to SRPRs and their future in order to better select them.
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.	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?
Evaluation of swallowing of patients	one day	Evaluate by clinical data recorded in the medical file at upon entry into SRPR service.
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.	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?
Evaluation of nutritional status of patients	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.

Trial Locations

Locations (10)

Hôpital de Forcilles; 🇫🇷 Férolles-Attilly, France

Hôpital d'instruction des armées - Percy; 🇫🇷 Clamart, France

Hôpital Raymond Poincaré - SRPR pédiatrique; 🇫🇷 Garches, France

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Hôpital Raymond Poincaré de Garches - SRPR neurologique; 🇫🇷 Garches, France

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Hôpital Charles-Nicolle - CHU de Rouen; 🇫🇷 Rouen, France

Groupe hospitalier des portes de l'Oise; 🇫🇷 Beaumont-sur-Oise, France

Centre hospitalier de Bligny; 🇫🇷 Briis-sous-Forges, France

Hôpital Sainte-Anne; 🇫🇷 Paris, France