Real-time Location System Feasibility Study

Surgery Clinical Trial

Official title:

Real-time Location System Feasibility Study Part 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988751
• Other study ID #: IRB00039439
• Status: Completed
• Phase: N/A
• Start date: June 6, 2019
• Est. completion date: August 19, 2022

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.

In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 19, 2022
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria

• Male or female patients between the ages of 18 and 90.

• Admitted to the Surgical Ward.

• Recovering from surgery.

• Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.

• Ability to understand and complete the study survey instruments in English.

Exclusion criteria

• Non-surgical patient.

• Emergency surgical procedure.

• Anticipated discharge less than 24 hour.

• Unable to ambulate or ambulation not permitted by treating provider.

• Unable to understand and complete the study survey instruments in English.

• Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.

Related Conditions & MeSH terms

• Mobility
• Surgery

Intervention

Behavioral:
• Ambulation
Variation in ambulatory intensity.

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.	Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.	1 day