- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07649499
The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-related Infiltration and Phlebitis in the Pediatric Emergency Department
The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-Related Infiltration and Phlebitis in the Pediatric Emergency Department: A Quasi-Experimental Study
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye)
- Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Children admitted to the Pediatric Emergency Department
First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years
At least 6 hours of observation after catheter insertion
Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium)
Written informed consent obtained from parents/legal guardians
Children willing to participate in the study
Exclusion Criteria:
Children with skin problems (e.g., epidermolysis bullosa)
Children allergic to products used in the care bundle
Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies)
Children transferred to intensive care or another department after PIVC insertion
Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Group (Care Bundle)
The intervention group will receive a care bundle consisting of the following: Nurse Education on peripheral intravenous catheter (PIVC) management. Hand Hygiene and adherence to aseptic techniques during PIVC insertion. Use of 2% chlorhexidine and 70% alcohol antiseptic solutions for PIVC insertion. Hydrocolloid transparent adhesive bandage for stabilization of the catheter. Nurses will avoid performing more than two attempts for PIVC insertion. Aseptic technique will be strictly followed during PIVC insertion and maintenance. |
The intervention group will receive a care bundle designed to reduce peripheral intravenous catheter (PIVC)-related complications (infiltration and phlebitis). The bundle includes the following components: Nurse Education: Training on PIVC management and best practices. Hand Hygiene: Emphasis on proper hand hygiene before and after each insertion and maintenance procedure. Aseptic Techniques: Strict adherence to aseptic technique during PIVC insertion and maintenance. Antiseptic Solutions: Use of 2% chlorhexidine and 70% alcohol for skin preparation and catheter insertion. Stabilization: Use of hydrocolloid transparent adhesive bandages for catheter fixation to prevent dislodgement and reduce irritation. Insertion Attempts: Limiting the number of attempts to a maximum of two to reduce trauma to the insertion site. Monitoring and Documentation: Regular assessment of the PIVC site for complications and accurate documentation by nursing staff. |
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간섭 없음: Control Group (Standard Care)
The control group will receive standard care as per routine practice in the pediatric emergency department: Standard peripheral intravenous catheter (PIVC) insertion procedures as performed by clinical staff. No additional interventions such as nurse education or the specific antiseptic solutions or stabilization methods will be applied. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Peripheral Intravenous Catheter-Related Infiltration
기간: From the time of catheter insertion to 6 hours post-insertion
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The primary outcome is the incidence of PIVC-related infiltration in pediatric patients.
Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
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From the time of catheter insertion to 6 hours post-insertion
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Incidence of Peripheral Intravenous Catheter-Related Phlebitis
기간: From the time of catheter insertion to 6 hours post-insertion.
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the incidence of PIVC-related phlebitis.
Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).
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From the time of catheter insertion to 6 hours post-insertion.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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First Attempt Success Rate for PIVC Insertion
기간: Procedure (During initial PIVC insertion attempt.)
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The percentage of successful PIVC insertions on the first attempt.
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Procedure (During initial PIVC insertion attempt.)
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Number of PIVC Insertions
기간: At the time of PIVC insertion procedure
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The total number of PIVC insertion attempts for each patient. Assessment Method: Clinical record review. |
At the time of PIVC insertion procedure
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Nurse Adherence to Care Bundle Protocol
기간: At the time of PIVC insertion procedure
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The degree to which nurses adhere to the care bundle protocol (hand hygiene, aseptic techniques, antiseptic use, etc.). Assessment Method: Adherence checklists and observation by researchers |
At the time of PIVC insertion procedure
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- GizemPIVC2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .
Care Bundle for PIVC Management에 대한 임상 시험
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Pro-Change Behavior Systems완전한
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University of AlbertaPublic Health Agency of Canada (PHAC)완전한
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VA Eastern Colorado Health Care SystemUS Department of Veterans Affairs모병
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Chestnut Health SystemsNational Institute on Drug Abuse (NIDA)모병
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Attikon HospitalDepartment of Gastroenterology, Central Clinical School, Monash University완전한
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University of BirminghamNational Institute for Health Research, United Kingdom알려지지 않은