Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients

Breast Cancer Clinical Trial

Official title:

Effect of Precise Grip Strength Training on PICC Catheter-Related Thrombosis in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638048
• Other study ID #: YXLL-KY-2022(057)
• Status: Completed
• Phase: N/A
• Start date: July 10, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: February 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, color Doppler ultrasound diagnostic instrument and electronic grip device were used to determine the best grip strength of patients with tumor PICC catheterization, formulate precise and standardized grip strength training guidance for them, provide personalized functional exercise health education, and observe the impact of precise grip strength training guidance on Peripheral central venous catheter-associated thrombosis. To provide a reference for clinical prevention of Peripheral central venous catheter-associated thrombosis in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 10, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Cancer patients undergoing chemotherapy throughout their treatment in our hospital
• Patients with PICC implanted for the first time and maintained at our hospital;
• Age 18-60 years;
• Normal cognitive function;
• the clenching movement is barrier-free;
• The material and performance of PICC catheter are silicone three-way valve catheter;
• Catheter placement under the guidance of portable color Doppler ultrasound diagnostic instrument;
• Voluntarily participate and sign the informed consent form.

Exclusion Criteria:

• Patients treated with combined radiotherapy;
• Patients with coagulation dysfunction;
• Patients who need to use anticoagulant drugs due to underlying diseases;
• Puncture times more than 1 time;
• The blood flow velocity of catheterization vessel in calm state was less than 4.78cm/s.

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Liver Cancer
• Lung Cancer
• Rectal Cancer
• Stomach Cancer
• Stomach Neoplasms
• Thrombosis

Intervention

Behavioral:
• Precision grip training
First determine patients for holding the ball movement should reach the effective blood flow velocity and best duration - relaxation, and USES the electronic grips and color doppler ultrasonic diagnostic apparatus, for individual patients to choose the best grip the efforts and training, to form the best grip the training plan, and observe the scheme for Peripheral central venous catheter-associated thrombosis prevention effect.
• Use maximum strength grip training
Patients were routinely implanted with PICC, and on the basis of health education in the control group, the best continuous-relaxation time, frequency and maximum grip strength of patients were used for grip strength training.
• Health education on routine grip strength training
Patients were routinely implanted with PICC and received routine health education. The content of health education included face-to-face language explanation of the whole process of catheter knowledge, issuing catheter maintenance manual, issuing ordinary grip ball and telling how to use it, and follow-up.

Locations

Country	Name	City	State
China	Qianfoshan Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Junyan Zhao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Peripheral central venous catheter-associated thrombosis in patients with PICC tube	Before catheterization, 24 hours after catheterization, and weekly maintenance, color Doppler ultrasound diagnostic instrument was used to diagnose venous thrombosis (including asymptomatic thrombosis) and its classification. The patients were observed for 8 weeks.	8 weeks
Secondary	Hemodynamic changes of the patient	During weekly maintenance, color Doppler ultrasound was used to measure the blood velocity of the arm axillary vein on the side of the catheter, and the maximum blood velocity (Vmax, cm/s) was recorded.	8 weeks
Secondary	Analysis of the influencing factors of Peripheral central venous catheter-associated thrombosis formation	By investigating the baseline data of patients, the related factors affecting the formation of PICC-CRT in patients with tumor tube in the baseline data of the same group were analyzed and compared.	8 weeks
Secondary	Patients' satisfaction with health education after PICC catheterization	At the end of the intervention, the patients' attitude towards PICC catheterization health education questionnaire (self-made) was distributed to the study subjects, and the satisfaction of the study subjects with the health education after PICC catheterization was learned through the questionnaire.	8 weeks