Predictive Algorithms for Critical Rehabilitation Outcomes

NCT06532994 | Recruiting

• 1 other identifier: ZNYYIIT2024004
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing amount of evidence from evidence-based medicine indicates that early rehabilitation intervention for patients receiving mechanical ventilation is safe and feasible, and can promote functional recovery and reduce hospital stay. However, the conscious state, respiratory function, and daily living activities of these patients after being discharged from the ICU vary greatly, and some patients do not show obvious benefits. How to identify which patients may have benefit from early rehabilitation is a key issue that needs to be addressed in critical care rehabilitation. This study aims to investigate the clinical data related to the disease of the ICU survivors who received mechanical ventilation as the research object, by collecting their clinical data when receiving early rehabilitation intervention, and constructing a clinical prediction model for the efficacy of early rehabilitation intervention in the ICU through the selection of optimal regression equation or machine learning algorithm. The application of this model can effectively determine whether ICU inpatients need early rehabilitation intervention, thereby reducing complication rates and improving their quality of life.

Conditions

Intensive Care; Rehabilitation; Mechanical Ventilation; Algorithms

Outcome Measures

Primary Outcomes (1)

• Functional Independence Measure (FIM) scale

  The Functional Independence Measure (FIM) scale is a widely used tool designed to assess an individual's level of disability and functional independence in activities of daily living (ADLs). The FIM scale consists of 18 items divided into two main categories: \*\*self-care\*\* and \*\*mobility\*\*, each evaluating specific tasks such as eating, bathing, dressing, and transferring. Each item is scored on a scale from 1 to 7, where: * 1 indicates total dependence (the individual requires assistance), * 7 indicates complete independence (the individual performs the task safely and independently). The total FIM score can range from 18 to 126, with higher scores representing greater functional independence levels.

  From date of enrollment until the date of ADL improvement (FIM increase ≥ 5) or date of participants are transferred out of the ICU. FIM score was assessed every other day after treatment starts and up to 6 weeks.

Study Arms (1)

Survivors of ICU with Mechanical Ventilation

Survivors of ICU with Mechanical Ventilation are individuals who have been treated in an intensive care unit (ICU) and require the use of a mechanical ventilator to assist their breathing with no mortality events occurring.

Other: Early rehabilitation intervention

Interventions

Early rehabilitation intervention OTHER

Based on the indications for early rehabilitation intervention outlined in the "Chinese Expert Consensus on Neurological Critical Care Rehabilitation," early rehabilitation interventions are categorized into three stages according to the patient's consciousness level (GCS score), degree of cooperation (S5Q score), and sedation status (RASS score)

Survivors of ICU with Mechanical Ventilation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients received mechanical ventilation and early rehabilitation interventions, regardless of the primary diagnosis.

You may qualify if:

• Age older than 18 years;
• Received mechanical ventilation, including endotracheal intubation and tracheostomy, during ICU admission;
• Met the rehabilitation intervention indications outlined in the "Chinese Expert Consensus on Neurocritical Rehabilitation" during ICU admission and underwent corresponding early rehabilitation interventions, including but not limited to arousal therapy for consciousness disorders, early active/passive mobilization, comprehensive pulmonary rehabilitation, etc.;
• No mortality events occurred during ICU admission;
• Informed consent form signed by family members or the patient.

You may not qualify if:

• Pediatric patients under 18 years of age;
• Hospitalized patients in the ICU who did not receive mechanical ventilation;
• Patients in the ICU who did not undergo early rehabilitation interventions;
• mortality events occurred during ICU admission;
• Patients transferred out of the ICU due to treatment abandonment by family members;
• Family refusal to sign the informed consent form or patient refusal to sign the informed consent form when conscious and competent.

Sponsors & Collaborators

• Wuhan University: lead
• General Hospital of the Yangtze River Shipping/Wuhan Brain Hospital: collaborator
• Wuchang Hospital Affiliated to Wuhan University of Science and Technology: collaborator

Study Sites (1)

Zhongnan hospital of Wuhan University

Wuhan, Hubei, 430070, China

RECRUITING

Related Publications (8)

• Adhikari NK, Fowler RA, Bhagwanjee S, Rubenfeld GD. Critical care and the global burden of critical illness in adults. Lancet. 2010 Oct 16;376(9749):1339-46. doi: 10.1016/S0140-6736(10)60446-1. Epub 2010 Oct 11.

  PMID: 20934212 BACKGROUND

• Liu L, Gao Z, Yang Y, Li M, Mu X, Ma X, Li G, Sun W, Wang X, Gu Q, Zheng R, Zhao H, Xie J, Qiu H. Economic variations in patterns of care and outcomes of patients receiving invasive mechanical ventilation in China: a national cross-sectional survey. J Thorac Dis. 2019 Jul;11(7):2878-2889. doi: 10.21037/jtd.2019.07.51.

  PMID: 31463117 BACKGROUND

• Stiller K. Physiotherapy in intensive care: towards an evidence-based practice. Chest. 2000 Dec;118(6):1801-13. doi: 10.1378/chest.118.6.1801. No abstract available.

  PMID: 11115476 BACKGROUND

• 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 BACKGROUND

• Schaller SJ, Anstey M, Blobner M, Edrich T, Grabitz SD, Gradwohl-Matis I, Heim M, Houle T, Kurth T, Latronico N, Lee J, Meyer MJ, Peponis T, Talmor D, Velmahos GC, Waak K, Walz JM, Zafonte R, Eikermann M; International Early SOMS-guided Mobilization Research Initiative. Early, goal-directed mobilisation in the surgical intensive care unit: a randomised controlled trial. Lancet. 2016 Oct 1;388(10052):1377-1388. doi: 10.1016/S0140-6736(16)31637-3.

  PMID: 27707496 BACKGROUND

• Balas MC, Burke WJ, Gannon D, Cohen MZ, Colburn L, Bevil C, Franz D, Olsen KM, Ely EW, Vasilevskis EE. Implementing the awakening and breathing coordination, delirium monitoring/management, and early exercise/mobility bundle into everyday care: opportunities, challenges, and lessons learned for implementing the ICU Pain, Agitation, and Delirium Guidelines. Crit Care Med. 2013 Sep;41(9 Suppl 1):S116-27. doi: 10.1097/CCM.0b013e3182a17064.

  PMID: 23989089 BACKGROUND

• Hodgson CL, Stiller K, Needham DM, Tipping CJ, Harrold M, Baldwin CE, Bradley S, Berney S, Caruana LR, Elliott D, Green M, Haines K, Higgins AM, Kaukonen KM, Leditschke IA, Nickels MR, Paratz J, Patman S, Skinner EH, Young PJ, Zanni JM, Denehy L, Webb SA. Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults. Crit Care. 2014 Dec 4;18(6):658. doi: 10.1186/s13054-014-0658-y.

  PMID: 25475522 BACKGROUND

• Bakhru RN, Wiebe DJ, McWilliams DJ, Spuhler VJ, Schweickert WD. An Environmental Scan for Early Mobilization Practices in U.S. ICUs. Crit Care Med. 2015 Nov;43(11):2360-9. doi: 10.1097/CCM.0000000000001262.

  PMID: 26308435 BACKGROUND

Central Study Contacts

Qing' Shu, Ph.D

CONTACT

+86 13971081682; shuqingj@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 1, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)