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Effects of Different Tunnel Methods in PICC Catheterization

2026년 5월 18일 업데이트: Zeyin Hu, Sun Yat-sen University

Effects of Different Tunnel Methods in PICC Catheterization: A Randomized Controlled Trial

This prospective randomized controlled trial compares the effectiveness and safety of one-needle and two-needle tunneling techniques for peripherally inserted central catheter (PICC) placement, aiming to identify the optimal tunneling method to reduce catheter-related complications.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

284

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Zeyin Hu
전화번호: 15899954190
이메일: huzy@sysucc.org.cn

연구 장소

중국
- Guangdong
  - Guangzhou, Guangdong, 중국, 510000
    - 모병
    - Sun Yat-sen University Cancer Center
    - 연락하다:
      
      Zeyin Hu
      
      전화번호: 15899954190
      
      이메일: huzy@sysucc.org.cn

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

Aged between 18 and 75 years old;
Educational level of primary school or above, with basic listening, speaking, reading and writing abilities, and capable of completing the questionnaire independently;
Receiving tunneled PICC catheterization for the first time, with 4Fr single-lumen solo PICC catheter indwelling;
Able to attend regular PICC maintenance at our hospital as scheduled after catheterization;
Voluntarily participate in this study and sign the informed consent form for this study as well as the informed consent form for PICC catheterization.

Exclusion Criteria:

Patients with coagulation dysfunction (INR > 1.5 / PLT < 50×10⁹/L);
Pregnant or lactating women;
Patients with BMI < 18.5 kg/m²;
Patients receiving PICC catheterization via lower extremity veins;
Patients with known or suspected allergy to components of PICC catheters.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 다른
할당: 무작위
중재 모델: 병렬 할당
마스킹: 삼루타

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
활성 비교기: cancer patients who undergo PICC placement using two-needle tunnel technique Two-needle tunnel PICC procedure: Local anesthesia at puncture and catheter exit sites; Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; Skin dilation at both puncture and exit sites; 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; Vascular sheath peeled off, catheter adjusted to proper position; Catheter tip position confirmed; Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.	다른: two-needle tunnel technique Two-needle tunnel PICC procedure: Local anesthesia at puncture and catheter exit sites; Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle; Skin dilation at both puncture and exit sites; 4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution; Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site; Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal; Vascular sheath peeled off, catheter adjusted to proper position; Catheter tip position confirmed; Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.
실험적: cancer patients who undergo PICC placement using one-needle tunnel technique Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation: Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; The guide wire is inserted along the puncture needle; skin dilation; The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; The catheter tip position is confirmed, and the catheter is secured.	다른: One-needle tunnel technique Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel; The guide wire is inserted along the puncture needle; skin dilation; The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath; The catheter tip position is confirmed, and the catheter is secured.

참가자 그룹 / 팔

개입 / 치료

활성 비교기: cancer patients who undergo PICC placement using two-needle tunnel technique

Two-needle tunnel PICC procedure:

Local anesthesia at puncture and catheter exit sites;
Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;
Skin dilation at both puncture and exit sites;
4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;
Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;
Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;
Vascular sheath peeled off, catheter adjusted to proper position;
Catheter tip position confirmed;
Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.

다른: two-needle tunnel technique

Two-needle tunnel PICC procedure:

Local anesthesia at puncture and catheter exit sites;
Ultrasound-guided vascular puncture at puncture site, guide wire inserted via puncture needle;
Skin dilation at both puncture and exit sites;
4cm saline tunnel created with 0.9% NaCl: 10mL syringe advanced along tunnel path while injecting solution;
Subcutaneous tunnel formed from exit site to puncture site with tunneling tool, catheter pulled through tunnel to puncture site;
Vascular sheath inserted over guide wire, catheter trimmed to length, advanced through sheath after guide wire removal;
Vascular sheath peeled off, catheter adjusted to proper position;
Catheter tip position confirmed;
Puncture site closed with suture-free tape, both sites covered with sterile dressings, catheter secured.

실험적: cancer patients who undergo PICC placement using one-needle tunnel technique

Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation:

Local anesthesia is administered at the puncture site，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;
The guide wire is inserted along the puncture needle;
skin dilation;
The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;
The catheter tip position is confirmed, and the catheter is secured.

다른: One-needle tunnel technique

Local anesthesia is administered at the puncture site，Ultrasound guidance is used for vascular puncture and assisted subcutaneous tunnel creation，the puncture needle travels 4 cm through the subcutaneous tissue before entering the blood vessel;
The guide wire is inserted along the puncture needle;
skin dilation;
The vascular sheath is advanced into the blood vessel via the guide wire, and the catheter is inserted through the vascular sheath;
The catheter tip position is confirmed, and the catheter is secured.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
overall PICC-related complications after catheter placement 기간: 4 weeks after PICC placement	these complications include catheter exit site oozing, contact dermatitis, venous thrombosis, infection, catheter displacement or dislodgement, mechanical phlebitis, catheter occlusion, and catheter fracture or damage.	4 weeks after PICC placement

2차 결과 측정

결과 측정	측정값 설명	기간
first-puncture success rate of PICC catheterization 기간: day 1 during PICC catheterization		day 1 during PICC catheterization
Bleeding during PICC placement 기간: Day 1 during PICC placement		Day 1 during PICC placement
unplanned catheter removal rate of PICC 기간: 4 weeks after PICC placement		4 weeks after PICC placement
pain score 기간: Day 1 during PICC placement	Evaluated by Numerical Rating Scale , a self-report tool where individuals rate their pain intensity from 0 (no pain) to 10 (worst possible pain)，with higher scores indicating more severe pain.	Day 1 during PICC placement

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sun Yat-sen University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 1일

기본 완료 (추정된)

2026년 6월 30일

연구 완료 (추정된)

2026년 7월 30일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 5월 13일

처음 게시됨 (실제)

2026년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 18일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

B2026-068-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Effects of Different Tunnel Methods in PICC Catheterization