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Clinical Trials/NCT03470662
NCT03470662CompletedNot Applicable

Effect of Prospective Care Bundle on Prevention of Delirium Among Elderly Patients With Hip Fractures

Zhoupu Hospital, Pudong New Area, Shanghai, China1 site in 1 country80 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
incidence of delirium among elderly patients with hip fractures

Study Overview

Brief Summary

Objective: To evaluate the effect of care bundle on prevention of delirium among elderly patients with hip fractures.

Methods: A prospective randomized case control study was performed for 80 patients (≥65 years) with hip fractures treated surgically according to their ages and the type of fractures from March 1th of 2017 to June 30th of 2017.There were 11 males and 69 females, with the age of (79.3±7.84) years. Confusion assessment method (CAM) was applied to diagnose delirium after surgery, the subjects were randomized divided into experimental group (n=43) and control group (n=37). The parameters next were recorded and analyzed, including age, gender, type of fractures, type of internal instrument, amount of bleeding, time between injured to surgery, time length of operation, type of operation, VAS, incidence of delirium, perioperative complications and adverse events.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •≥65 years
  • •with hip fractures
  • •treated surgically

Exclusion Criteria

  • •<65 years
  • •psychiatric history
  • •ICU post-operation
  • •refuse to join this study
  • •have delirium pre-operation

Arms & Interventions

experimental group

Experimental

Care bundle

Intervention: Care bundle (Other)

control group

No Intervention

routine care

Outcomes

Primary Outcomes

incidence of delirium among elderly patients with hip fractures

Time Frame: 3 weeks

study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Zhoupu Hospital, Pudong New Area, Shanghai, China
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiaoxiao Zhou

Director of Orthopaedics Department

Zhoupu Hospital, Pudong New Area, Shanghai, China

Study Sites (1)

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