NCT06193447

Brief Summary

This study was planned to determine the mobilization process and factors affecting this process in patients who underwent open heart surgery and were admitted to the cardiovascular surgery intensive care unit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

December 18, 2023

Last Update Submit

January 5, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Postoperative mobilization level

    Assessed with Intensive Care Units-Mobility Scale. The scale used to evaluate patient mobiility level on postoperative days. It consisted of 11 items with scoring, classification and explanation from 0 (zero) to 10 (ten), ranging from lying in bed/passive exercises to independent ambulation.

    Postoperative day 2

  • Pulse rate changes between before and after mobility

    Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.

    Twice: Before mobilization and after mobilization (5 minutes later)

  • Blood pressure (both of systolic and diastolic blood pressure) changes between before and after mobility

    Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.

    Twice: Before mobilization and after mobilization (5 minutes later)

  • Oxygen saturation changes between before and after mobility

    Assessed with a form which is created by authors. The form is containing the outcome both of before and after mobilization. These are calculated both time point.

    Twice: Before mobilization and after mobilization (5 minutes later)

Interventions

None intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Undergoing open heart surgery patients

You may qualify if:

  • Being over 18 years old
  • Staying in the cardiovascular intensive care unit for 24 hours or more

You may not qualify if:

  • Being diagnosed with a psychiatric disorder
  • Do not have active bleeding
  • Do not have arrhythmia
  • Reporting pain intensity of 4 or above on the Visual Analog Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ezgi Arslan

Efeler, Aydın, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 5, 2024

Study Start

January 2, 2023

Primary Completion

September 15, 2023

Study Completion

December 15, 2023

Last Updated

January 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
12 months after publication
Access Criteria
Relevance to the topic of the study and approval of all-authors within 1 month of receiving the request.

Locations