Predictive Value of β2-microspheres for Postoperative Delirium

The Predictive Value of β2-microspheres for Postoperative Delirium in the Elderly After Orthopedic Surgery

This study evaluated the predictive value of β2-microspheres for postoperative delirium (POD) in the elderly after orthopedic surgery. For this purpose, the levels of β2-microspheres in plasma and cerebrospinal fluid were compared between the POD and non-POD groups.

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium

Detailed Description

In this study, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres before operation. Also, the patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups. The aim of the present study was to assess whether higher levels of β2-microspheres could predict the occurrence of POD.

• Study Type: Observational
• Enrollment (Actual): 184

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients aged ≥65 years undergoing orthopedic operations under spinal anesthesia were investigated.

Description

Inclusion Criteria:

• ≥65 years old, American Standards AssociationⅠ-Ⅲ, undergoing orthopedic operations under spinal anesthesia

Exclusion Criteria:

• decline to participate

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
POD group; POD group refers to the patients who were diagnosed to be delirious by the Confusion Assessment Method.
Non-POD group; Non-POD refered to the patients who did not become delirious by the Confusion Assessment Method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of POD	The patients were interviewed one day before the surgery and on postoperative days 1-3 by the Confusion Assessment Method and then divided them into POD and non-POD groups.	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The levels of β2-microspheres in plasma and cerebrospinal fluid	Before surgery, plasma and cerebrospinal fluid of the patients were collected to detect the levels of β2-microspheres.	1 day

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Jian-jun Yang, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): December 30, 2017

Study Registration Dates

• First Submitted: April 15, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 24, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Delirium β2-microspheres
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 199101026046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No