Prevention of Delirium Among Elderly Patients With Hip Fractures

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470662
• Other study ID #: YuFengbinDelirium
• Status: Completed
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 18, 2018
• Start date: March 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: March 2018
• Source: Zhoupu Hospital, Pudong New Area, Shanghai, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Care bundle
Care bundle

Locations

Country	Name	City	State
China	Zhoupu Hospital Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhoupu Hospital, Pudong New Area, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delirium among elderly patients with hip fractures	study hypothesis: the incidence of delirium postoperatively in experimental group is lower compared with control group	3 weeks