Clinical trial NCT05106244: Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
Official title: The Application of Remote Real-Time Guidance System in Home Care of Patients With PICC or PORT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Neoplasms
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: From January 2022 to October 2022, 200 patients with digestive tract tumors with indwelling PICC or PORT in the inpatient department of oncology surgery in First Affiliated Hospital of Xian Jiaotong University were randomly divided into control group (hospital nursing mode) and experimental group (family self-nursing mode) . The specific methods were as follows: 2-1 the control group adopted regular nursing mode after catheterization. The patients were mainly given on-site catheterization nursing by specialist nurses, and health consultation and guidance were carried out during the period of catheterization. 2-2 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 specific operation procedures are as follows: (1) make nursing videos recorded and reviewed by central venous catheter specialist nurses (video production is carried out separately for different central venous access devices from different manufacturers, as well as follow-up training steps). (2) evaluate the nursing operation ability of the patients' family members and carry out relevant training and health education, including hand washing, aseptic concept, matters needing attention in removing the film, flushing and sealing techniques, and local observation points at the puncture point, etc., repeatedly strengthen the training of key links and conduct assessment until the participants are qualified; (3) distribute nursing guidance prescriptions and maintenance manuals for central venous catheters. (4) provide online simulated realistic nursing video materials, nursing video materials are decomposed in detailed steps, each step is equipped with detailed language explanation and explanation, and the key links are reminders or warnings. It is convenient for patients' families to learn and master quickly; (5) provide real-time telephone audio and video connection to complete remote nursing guidance. (6) set up a home nursing volunteer service group, which is composed of nursing team members led by central venous catheter specialist nurses, establish a doctor-patient exchange group by using Wechat and other media, and provide nursing outpatient information of each central venous catheter in the area. Improve family nursing failure remedial measures, provide necessary guidance and help, and timely feedback. The normal service life of the catheter, the infection rate of the catheter puncture point, the catheter occlusion rate, the nursing experience and satisfaction of the patients and their families were compared between the two groups. Statistical processing: the data were analyzed by SPSS22.0 software. The measurement data are expressed as mean ± standard deviation, t-test is used, counting data is expressed as rate (%), and 2 test or Fisher exact probability method is used.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Average level of service life of the catheter
timeFrame: up to 10 months
measure: Incidence of puncture point infection
timeFrame: up to 10 months
measure: Incidence of catheter occlusion
timeFrame: up to 10 months
measure: Degree of satisfaction of patients and their families
timeFrame: up to 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xian Jiaotong University
name: Yong Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: