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

NCT07093125 | Recruiting

• 1 other identifier: Liguria: 419/2024 - id 14164
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

Brief Summary

This international, multicenter, observational study aims to describe rehabilitation practices in Intensive Care Units (ICUs) worldwide. The primary objective is to provide an overview of current rehabilitation strategies used in ICUs globally. Secondary objectives include assessing the relationship between rehabilitation and key ICU outcomes such as ICU and hospital mortality, length of stay, duration of invasive ventilation, extubation failures, and long-term outcomes including quality of life and functional performance 28 days post-ICU discharge. The study will also compare rehabilitation practices across different geographic and economic regions to identify potential disparities. The study is structured into three modules, with participation contingent on local resources and feasibility. The BASIC Module (mandatory for all centers) gathers fundamental data on rehabilitation practices and their association with patient outcomes. The EXTENDED Module (optional) collects more detailed information on the type, timing, duration, and safety of rehabilitation interventions, including passive exercises, active mobilization, respiratory therapies, dysphagia training, occupational therapy, and cognitive support. The EXTENDED FOLLOW-UP Module (optional) evaluates the patient's quality of life and functional recovery 28 days after ICU discharge. By examining global rehabilitation practices and their impact on patient outcomes, this study aims to improve rehabilitation strategies in ICUs, contributing to better patient care, recovery, and long-term health outcomes.

Conditions

Mechanical Ventilation; Pulmonary Rehabilitation; Extubation Failure; Mortality; Critical Care; Intensive Care Units (ICUs); Quality of Life (QOL); Outcome Assessment

Keywords

Pulmonary rehabilitation; Mechanical Ventilation; Intensive Care Unit (ICU); Rehabilitation Outcomes

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who received at least one rehabilitation intervention

  Rehabilitation is defined as the delivery of at least one documented intervention during ICU stay, including passive mobilization, active mobilization, or respiratory physiotherapy (active or passive), reported as percentage (%).

  From ICU admission (Day 0) until ICU discharge (up to day 28)

Secondary Outcomes (16)

• Proportion of rehabilitation sessions with at least one Serious Adverse Event (SAE)

  From ICU admission (Day 0) until ICU discharge (up to day 28)

• Duration of rehabilitation interventions per day (minutes)

  From ICU admission (Day 0) until ICU discharge (up to day 28)

• Proportion of rehabilitation sessions with physiological monitoring

  From ICU admission (Day 0) until ICU discharge (up to day 28)

• Highest level of mobility during ICU stay

  From ICU admission (Day 0) until ICU discharge (up to day 28)

• Muscle Strength

  From ICU admission (Day 0) until ICU discharge (up to day 28)

Study Arms (1)

Adult patients admitted in ICU and on mechanical ventilation for at least 48 hours

Adult patients who can be candidated to rehabilitation during ICU stay

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise adult patients admitted to Intensive Care Units (ICUs) located in cities and countries participating in the study. Eligible patients will be adult patients requiring invasive mechanical ventilation for at least 48 hours and who can be candidate for rehabilitation during ICU stay. Enrolment will be conducted in accordance with applicable local regulations, including the provision of informed consent by the patient or their legally authorized representative.

You may qualify if:

• Patients admitted to a participating ICU
• Adult patients (aged 16 years or older, depending on local regulations for the definition of "adults")
• Patients who have received invasive ventilation for at least 48 hours
• Patients who have obtained written informed consent from the patient or next of kin (if local legislation demands so)

You may not qualify if:

• Patients admitted for withdrawn of life sustain therapy

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: collaborator
• Universita degli Studi di Genova: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132, Italy

RECRUITING

Related Publications (8)

• Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.

  PMID: 18283429 RESULT

• TEAM Study Investigators and the ANZICS Clinical Trials Group; Hodgson CL, Bailey M, Bellomo R, Brickell K, Broadley T, Buhr H, Gabbe BJ, Gould DW, Harrold M, Higgins AM, Hurford S, Iwashyna TJ, Serpa Neto A, Nichol AD, Presneill JJ, Schaller SJ, Sivasuthan J, Tipping CJ, Webb S, Young PJ. Early Active Mobilization during Mechanical Ventilation in the ICU. N Engl J Med. 2022 Nov 10;387(19):1747-1758. doi: 10.1056/NEJMoa2209083. Epub 2022 Oct 26.

  PMID: 36286256 RESULT

• Tipping CJ, Harrold M, Holland A, Romero L, Nisbet T, Hodgson CL. The effects of active mobilisation and rehabilitation in ICU on mortality and function: a systematic review. Intensive Care Med. 2017 Feb;43(2):171-183. doi: 10.1007/s00134-016-4612-0. Epub 2016 Nov 18.

  PMID: 27864615 RESULT

• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 RESULT

• Van Aerde N, Meersseman P, Debaveye Y, Wilmer A, Gunst J, Casaer MP, Bruyninckx F, Wouters PJ, Gosselink R, Van den Berghe G, Hermans G. Five-year impact of ICU-acquired neuromuscular complications: a prospective, observational study. Intensive Care Med. 2020 Jun;46(6):1184-1193. doi: 10.1007/s00134-020-05927-5. Epub 2020 Jan 22.

  PMID: 31970446 RESULT

• Ali NA, O'Brien JM Jr, Hoffmann SP, Phillips G, Garland A, Finley JC, Almoosa K, Hejal R, Wolf KM, Lemeshow S, Connors AF Jr, Marsh CB; Midwest Critical Care Consortium. Acquired weakness, handgrip strength, and mortality in critically ill patients. Am J Respir Crit Care Med. 2008 Aug 1;178(3):261-8. doi: 10.1164/rccm.200712-1829OC. Epub 2008 May 29.

  PMID: 18511703 RESULT

• Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.

  PMID: 24247473 RESULT

• Appleton RT, Kinsella J, Quasim T. The incidence of intensive care unit-acquired weakness syndromes: A systematic review. J Intensive Care Soc. 2015 May;16(2):126-136. doi: 10.1177/1751143714563016. Epub 2014 Dec 18.

  PMID: 28979394 RESULT

Study Officials

• Denise Battaglini, MD, PhD

  Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy

  PRINCIPAL INVESTIGATOR

• Marcus J Schultz, MD, PhD

  Amsterdam University Medical Centers, Amsterdam, The Netherlands

  STUDY CHAIR

• Rik Gosselink, PT, PhD

  University of Leuven, Leuven, Belgium

  STUDY CHAIR

• Sabrine N.T. Hemmes, MD, PhD

  Amsterdam University Medical Centers, Amsterdam, The Netherlands

  STUDY CHAIR

• Carol L. Hodgson, PhD FACP FAHMS BAppSc(PT) MPhi

  Alfred Hospital, Melbourne, VIC, Australia

  STUDY CHAIR

• Ricardo Kenji Nawa, MD, PhD

  Hospital Israelita Albert Einstein, São Paulo, SP, Brazil

  STUDY CHAIR

• Irene Schiavetti, PhD

  University of Genoa, Italy

  STUDY CHAIR

• Ary Serpa Neto, MD, PhD

  Monash University, Melbourne, VIC, Australia

  STUDY CHAIR

• Gentle S. Shrestha, MD, PhD

  University Teaching Hospital, Kathmandu, Bagmati, Nepal

  STUDY CHAIR

Central Study Contacts

Denise Battaglini, MD, PhD

CONTACT

＋39 010 5554970; denise.battaglini@unige.it

Marcus J Schultz, MD, PhD

CONTACT

m.j.schultz@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: July 30, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)