Global Observational Study of Rehabilitation in ICU Patients on Invasive Mechanical Ventilation

What this Trial Is About

This international, multicenter observational study focuses on critically ill adult patients receiving invasive mechanical ventilation in Intensive Care Units ICUs worldwide. Researchers aim to describe and compare rehabilitation practices across different geographic and economic regions. The study seeks to understand how rehabilitation interventions relate to key ICU outcomes such as mortality, length of stay, ventilation duration, extubation failures, and long-term quality of life and functional recovery 28 days after ICU discharge. The study consists of three modules the BASIC module mandatory, which collects fundamental data on rehabilitation practices and patient outcomes the EXTENDED module optional, which gathers detailed information about rehabilitation types, timing, duration, safety, and delivery and the EXTENDED FOLLOW-UP module optional, which assesses quality of life and functional performance 28 days post-ICU discharge. Rehabilitation interventions studied include passive and active exercises, respiratory physiotherapy, dysphagia training, occupational therapy, and cognitive support. Participants are admitted ICU patients aged 16 or older who have received invasive ventilation for at least 48 hours. Data collection occurs at ICU admission, multiple ICU stay time points days 0, 3, 7, 14, and discharge, and at a 28-day follow-up post-ICU discharge. Assessments include muscle strength, mobility level, intervention duration, safety monitoring, and functional and quality of life evaluations. The study uses electronic data capture with thorough data validation, monitoring, and auditing to ensure data quality and integrity. Enrollment spans 120 days per center with an expected total of 1,200 to 2,400 patients worldwide.

Rehabilitation Practices in Critically Ill Patients Receiving Invasive Mechanical Ventilation in the Intensive Care Unit.