Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT

NCT05106244 | Unknown

• 1 other identifier: XJTU1AF2021LSK-300
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical treatment of digestive tract tumor patients often need chemotherapy before and after operation, most chemotherapy drugs will cause harm to patients, prone to leakage, leading to tissue necrosis. The construction of deep venous channels can protect the blood vessels of patients and reduce their pain. PICC and PORT have become a new clinical treatment technology, and have become the mainstream mode of long-term intravenous indwelling. Although the central venous catheterization technology has many advantages, it also has some limitations. Because of its long-term existence, periodic nursing needs to be carried out, such as correct flushing, sealing, replacement of film and so on. Incorrect care or failure to come to the hospital on time may lead to abnormal use of the catheter or shortening of service life, resulting in some unexpected pain. Under the influence of COVID-19 's epidemic situation, it becomes more difficult and unrealistic for patients to come to hospital regularly for nursing. During the epidemic, patients need more safe and effective care at home. In order to help patients with good central venous catheter nursing at home, this study intends to apply remote professional real-time guidance technology to home nursing care of PICC and PORT tumor patients. Through on-site practical operation training, video explanation materials of long-distance on-line decomposition steps and real-time telephone audio connection guidance are provided to enable patients' families to quickly learn to master nursing techniques, so as to achieve safe and effective self-care at home.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (4)

• Average level of service life of the catheter

  Average length of service life of PICC or PORT

  up to 10 months

• Incidence of puncture point infection

  Incidence of puncture point infection of PICC or PORT

  up to 10 months

• Incidence of catheter occlusion

  Incidence of catheter occlusion of PICC or PORT

  up to 10 months

• Degree of satisfaction of patients and their families

  a satisfaction survey of patients and their families, using a self-designed questionnaire.

  up to 10 months

Study Arms (2)

family self-nursing mode

EXPERIMENTAL

Other: Real-Time Guidance of Home Care for Patients with PICC or PORT

hospital nursing mode

NO INTERVENTION

Interventions

Real-Time Guidance of Home Care for Patients with PICC or PORT OTHER

the experimental group adopted the family self-nursing mode, mainly by the patients' family members to observe the catheter and do regular nursing, and the specialist nurses provided remote real-time online guidance to monitor the family nursing of central venous catheter. The procedures are as follows: (1) make nursing videos recorded by central venous catheter specialist nurses; (2) evaluate the nursing operation ability of the patients' family members and carry out relevant training and health education, repeat until they are qualified; (3) distribute nursing guidance prescriptions and maintenance manuals for central venous catheters; (4) provide online simulated realistic nursing video materials; (5) provide real-time telephone audio and video connection to complete remote nursing guidance. (6) set up a home nursing volunteer service group, establish a doctor-patient exchange group by using Wechat and other media.

family self-nursing mode

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with gastric cancer or colorectal cancer with indwelling central venous catheter (PICC or PORT)
• Age ≥18 years and ≤75 years
• Normal cognitive function
• Be informed of and actively cooperate with this study

You may not qualify if:

• Suffering from psychological disorders and not able to communicate normally
• Unable to cooperate due to other factors

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Catheterization, Peripheral

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Yong Zhang, Doctor

  First Affiliated Hospital of Xian Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Zhang, Doctor

CONTACT

0086-13709110938; 13709110938@163.com

XinRui Zhou, Bachelor's Degree

CONTACT

0086-15102937212; 3022658878@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: November 3, 2021
• Study Start: January 1, 2022
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2023-09

Locations

CN (1)