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NCT Number: NCT07765017

Early Mobilization and Prolonged ICU Stay in Postoperative Patients

This prospective observational cohort study aims to evaluate early mobilization in adult postoperative patients admitted to the intensive care unit (ICU) and to investigate its association with short-term clinical outcomes. Early meaningful mobilization is defined as achieving at least sitting at the edge of the bed (mobilization level ≥4) within the first 24 hours after ICU admission. Patients will be classified according to whether early meaningful mobilization is achieved. The primary objective is to evaluate the association between early meaningful mobilization and prolonged ICU stay. Secondary outcomes include mechanical ventilation requirement and duration, hospital length of stay, need for reintubation, development of delirium, complications occurring during mobilization, and ICU mortality.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

This is a prospective observational cohort study involving adult postoperative patients admitted to the intensive care unit (ICU). The study aims to systematically evaluate early mobilization practices and investigate the association between early mobilization and short-term clinical outcomes in postoperative ICU patients.

Mobilization performed within the first 24 hours after ICU admission will be evaluated according to predefined standardized criteria. Mobilization levels will be recorded using a scale ranging from passive movements to independent mobilization. Early meaningful mobilization is defined as achieving at least sitting at the edge of the bed (mobilization level ≥4) within the first 24 hours after ICU admission. Patients will be classified according to whether early meaningful mobilization is achieved.

The primary objective is to evaluate the association between early meaningful mobilization and prolonged ICU stay. Secondary objectives include evaluating its association with the requirement for and duration of mechanical ventilation, hospital length of stay, need for reintubation, development of delirium, complications occurring during mobilization, ICU mortality, and other early clinical outcomes.

Clinical factors potentially associated with the feasibility of early mobilization will also be evaluated. These include age, comorbidities, preoperative functional capacity, type and duration of surgery, APACHE II and SOFA scores at ICU admission, requirement for mechanical ventilation, vasopressor support, and sedation level. In patients who are not mobilized early, potential barriers to mobilization, including hemodynamic instability, respiratory insufficiency, deep sedation, pain, surgical restrictions, and organizational factors, will be recorded.

Patients will be followed throughout their ICU and hospital stay, and relevant clinical outcomes will be recorded. Demographic characteristics, surgical data, clinical parameters at ICU admission, mobilization status, and clinical outcomes will be collected using a standardized data collection form. All collected data will be anonymized for analysis.

No additional intervention or diagnostic test will be performed as part of the study. All study data will be obtained during routine clinical follow-up, directly from included patients, nursing observation forms, and electronic hospital records.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Admission to the intensive care unit for postoperative care
  • ICU stay of at least 24 hours
  • Ability to assess the patient's mobilization level within the first 24 hours following ICU admission
  • Provision of informed consent for participation in the study

Exclusion criteria

  • Age under 18 years
  • Pregnancy
  • Death within the first 24 hours after ICU admission
  • Clinical conditions contraindicating mobilization, including active massive bleeding, significant hemodynamic instability, unstable fracture, open abdomen, or similar conditions

Treatment and study plan

Primary outcomes

  1. Prolonged Intensive Care Unit Stay

    Time frame: Through ICU stay, an expected average of 3 days

    Prolonged ICU stay will be evaluated according to the duration of ICU hospitalization and compared between patients who achieve early meaningful mobilization and those who do not. Early meaningful mobilization is defined as achieving a mobilization level of ≥4 within the first 24 hours after ICU admission.

Secondary outcomes

  1. Mechanical Ventilation Requirement

    Time frame: Through ICU stay, an expected average of 3 days

    Requirement for invasive mechanical ventilation during the ICU stay

  2. Duration of Mechanical Ventilation

    Time frame: Through ICU stay, an expected average of 3 days

    Duration of invasive mechanical ventilation during the ICU stay, recorded in days.

  3. Hospital Length of Stay

    Time frame: Through hospitalization, an expected average of 7 days

    Total duration of hospitalization, recorded in days.

  4. Reintubation Requirement

    Time frame: Through ICU stay, an expected average of 3 days

    Occurrence of reintubation during the ICU stay.

  5. ICU Mortality

    Time frame: Through ICU stay, an expected average of 3 days

    All-cause mortality occurring during the ICU stay

Study contacts

Contact information is provided by the study sponsor or research team.

Dilek Kuzukıran Kocataş, MD

CONTACT

[email protected]

+905355261001

Sponsors and collaborators

Lead sponsor

Ankara Training and Research Hospital

Other

Registry information

Official study title

Association Between Early Mobilization and Prolonged Intensive Care Unit Stay in Postoperative Patients: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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