NCT07765017

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 7, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Early MobilizationPostoperative Intensive CareIntensive Care UnitProlonged ICU Stay

Outcome Measures

Primary Outcomes (1)

  • Prolonged Intensive Care Unit Stay

    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.

    Through ICU stay, an expected average of 3 days

Secondary Outcomes (5)

  • Mechanical Ventilation Requirement

    Through ICU stay, an expected average of 3 days

  • Duration of Mechanical Ventilation

    Through ICU stay, an expected average of 3 days

  • Hospital Length of Stay

    Through hospitalization, an expected average of 7 days

  • Reintubation Requirement

    Through ICU stay, an expected average of 3 days

  • ICU Mortality

    Through ICU stay, an expected average of 3 days

Study Arms (2)

Early Meaningful Mobilization

Postoperative ICU patients who achieve a mobilization level of ≥4 within the first 24 hours after ICU admission.

No Early Meaningful Mobilization

Postoperative ICU patients who do not achieve a mobilization level of ≥4 within the first 24 hours after ICU admission.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult postoperative patients admitted to the intensive care unit of Ankara Training and Research Hospital who meet the predefined eligibility criteria will constitute the study population. Participants will be prospectively evaluated for early mobilization during their ICU stay and followed for the clinical outcomes specified in the study protocol.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dilek Kuzukıran Kocataş, MD

    Ankara Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Kuzukıran Kocataş, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 14, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared because data sharing with external researchers was not included in the approved study protocol.