Incidence and Determinants of Joint Contractures in Mechanically Ventilated ICU Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorElazıg Fethi Sekin Sehir Hastanesi
About this trial
This prospective observational cohort study aims to evaluate the incidence and determinants of joint contracture development in mechanically ventilated adult patients admitted to the intensive care unit (ICU). Prolonged immobilization, deep sedation, and neuromuscular blockade are common in critically ill patients and may contribute to musculoskeletal complications, including joint contractures, which can adversely affect functional outcomes and rehabilitation after ICU discharge.
Adult patients who are mechanically ventilated, immobilized, and have impaired consciousness will be consecutively enrolled and followed during their ICU stay. Joint range of motion will be assessed using standardized passive range of motion (PROM) measurements performed with a goniometer at predefined intervals by trained assessors. Joint contracture will be defined as a reduction of at least 33% in passive joint range of motion compared with normal reference values.
This study is non-interventional, and all patients will receive routine ICU care and standard physiotherapy according to institutional protocols. No additional procedures or interventions will be applied for research purposes. Demographic characteristics, clinical variables, and ICU-related factors will be recorded to explore potential associations with contracture development.
The findings of this study are expected to provide prospective data on the burden of joint contractures in mechanically ventilated ICU patients and to identify modifiable risk factors that may inform future preventive and rehabilitative strategies in critical care practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Adult patients aged 18 and over
Patients on mechanical ventilation and monitored in the intensive care unit for at least 7 days
Glasgow Coma Score ≤10
Patients monitored immobile in the intensive care unit
Disqualifiers
• Presence of pre-existing joint contracture, ankylosis, or amputation
Patients with severe burns, fractures, or surgical reasons preventing joint movement
Patients with a history of neuromuscular disease or spasticity
Patients who were immobilized for ≥1 week prior to admission to the intensive care unit
Trial population
The study population consists of adult patients admitted to a tertiary-level intensive care unit who are mechanically ventilated, immobilized, and have impaired consciousness. Eligible participants are patients aged 18 years or older who are expected to remain in the ICU for at least seven days and are unable to mobilize independently due to their clinical condition. Patients with pre-existing joint contractures, neuromuscular diseases, spasticity, amputations, or conditions that preclude safe assessment of joint range of motion are excluded. All participants receive routine ICU care and standard physiotherapy according to institutional protocols, and no additional interventions are introduced for research purposes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Mechanically Ventilated ICU Patients
Trial outcomes
Primary outcomes
1
Incidence of Joint Contracture During ICU Stay
Development of a new joint contracture, defined as a ≥33% reduction in passive range of motion (PROM) compared with normal reference values, measured using a goniometer.
Time frame
From ICU admission to ICU discharge or death, whichever occurs first, assessed prospectively for up to 28 days of ICU stay.Secondary outcomes
1
Time to Joint Contracture Development
Time (in days) from ICU admission to the first detection of joint contracture.
Time frame
From ICU admission to the first documented detection of joint contracture, ICU discharge, or death, whichever occurs first, assessed for up to 28 days.Sponsors and contacts
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Source ClinicalTrials.gov