Report

REPOrt Study Summary

Study Title

Practice of REhabilitation and Physiotherapy and associations with Outcomes in critically ill invasively ventilated patients (REPOrt)--an international multicenter observational multimodule study.

Background

Critically ill patients on invasive ventilation often develop ICU-acquired weakness (ICU-AW), linked to higher mortality and long-term morbidity. Rehabilitation interventions, including mobilization, physical activity, respiratory physiotherapy, dysphagia training, occupational therapy, and cognitive/ pshycological support, has been reported beneficial but remain underused, which may be due to limitations in resources. Moreover, its impact on clinical outcomes remains uncertain.

Aim

The primary objective of this worldwide multicenter observational multimodule study is to assess rehabilitation practices in ICUs at a global level. The secondary objective is to evaluate their impact on key ICU outcomes such as ICU and hospital mortality, lengths of stay, duration of invasive ventilation, extubation failures, and ICU and hospital mortality. We will additionally explore the effect of rehabilitation on quality of life and functional performance 28 days after ICU discharge. We will also compare rehabilitation practices and association with outcomes across different geo–economic regions.

The study consists of three modules, with participation contingent on local capabilities and feasibility:

  1. a BASIC module [obligatory for all participating centers], that collects basic information on rehabilitation practices and association with outcomes.

  2. an EXTENDED module [optional], that in addition to the BASIC module collects more granular data on rehabilitation interventions, including type, timing, duration, safety, and professionals who delivers rehabilitation interventions. This module details the following rehabilitation interventions: (1) passive interventions, such as passive exercises, stretching, cycling, neuromuscular electical stimulation, continuous and passive range of motion; (2) active interventions, such as exercise therapy, activities of daily living training, mobilization, and cycling; (3) respiratory interventions such as positioning, airways clearance techniques, lung expansion exercises, positive airway pressure devices, active cycle of breathing techniques, forced expiratory techniques, assisted or stimulated cough maneuvers, insufflation–exsufflation, and inhalation therapy; (4) dysphagia training, and swallow screening test, and (5) occupational therapy, and (6) cognitive/phsycological therapy.

  3. an EXTENDED FOLLOW–UP module [optional], that in addition to the BASIC outcomes collects quality of life and functional performance 28 days after ICU discharge.

Study Design

International multicenter observational multimodule study.

Participants

Patients are eligible if: (1) admitted to a participating ICU; (2) aged 18 years or older (or aged 16 years or older, depending on local practice and ethics); (3) having received invasive ventilation for at least 48 hours, and (4) written informed consent from the patient or next of kin (if local legislation demand so, see below). Patients admitted for withdrawn of life sustain therapy are excluded. We foresee that no informed consent is needed for the BASIC module in many countries, as data are collected as part of routine care, with the exception of what will be collected in the EXTENDED FOLLOW–UP module. Written informed consent will be combined for participation in the BASIC and EXTENDED module, and separate for the EXTENDED FOLLOW–UP module.

Target number of cases

Invasively ventilated patients will be screened for eligibility during a locally decided and predefined period of 120 days, depending on the preferences of the national coordinator, but always within a year after the start of the study.

No formal sample size calculation is performed. We expect each center to enroll 20 to 40 patients, yielding a total of 1200–2400 patients if 60 centers will participate. This number seems sufficient to achieve a global picture of current practice of rehabilitation and associated clinical outcomes.

Study Period

Start of enrollment is planned for 2025; total duration of enrollment is 120 days in each center.

Data Collection Method

All data will be captured and stored in an electronic database. The study consists of 3 separate modules, with participation contingent on local capabilities. Each center must at least participate in the BASIC module.

Research Organization

Study coordination

Core steering committee members