- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06815510
마취 후 치료 단위 합병증 및 관련 요인의 유병률
마취 후 치료 단위 합병증 및 관련 요인의 유병률에 대한 다 중앙 관찰 전향 적 연구
The post-anesthesia care unit (PACU) is a crucial component of the surgical process, providing patients with vital support and monitoring as they recover from anesthesia. Despite advancements in perioperative anesthesia, PACU complications are still common. PACU organization and setup in low-income country like Ethiopia is poor. Previous research's done in some neighbor African countries presumed to have comparable to sociodemographic and economical profile shows varied degree of incidence and prevalence of PACU complication and associated factors. The main objective of this study is to determine the prevalence of PACU complications and its associated factors.
An institutional based prospective cohort study will be conducted in the PACUs of the three selected tertiary care hospitals in Ethiopia from Februery 15, 2025 to June 30, 2025. These data will be compared with those obtained in a tertiary hospital in Spain.
연구 개요
상태
상세 설명
Studying the prevalence and associated factors of PACU complications will be of great academic importance, serving as a valuable reference and resource for further research. It will also help identify risk factors attributable to PACU complications, providing critical insights for hospital administrators and policymakers in making informed decisions about resource allocation and system design to minimize these complications. Understanding the prevalence and potential risk factors of PACU complications is essential for optimizing patient care and improving outcomes. Identified risk factors for postoperative complications in the PACU include female sex, longer duration of anesthesia, and the occurrence of intraoperative complications. This study aims to explore the prevalence of complications in the PACU and identify potential contributing factors, providing valuable insights for healthcare providers and policymakers seeking to improve PACU care. the potential significance and implications of the study findings, includes; Improving the understanding of PACU complications and the associated risk factors, informing the development of targeted prevention and management strategies, enhancing patient safety and quality of care in the perioperative setting and providing a basis for future research and evidence-based clinical guidelines. The study will involve surgical patients admitted to the Post-Anesthesia Care Units (PACUs) of four hospitals: Hiwot Fana Comprehensive Specialized Hospital, Ayder Comprehensive Specialized Hospital, Jimma University Medical Center (Ethiopia) and Hospital Universitario de Gran Canaria Doctor Negrín (Spain). The research will take place from February 15, 2025, to June 30, 2025. Multicenter, prospective, observational cohort study will be conducted reviewing patients admitted to the PACU. Analyzing complications in all patients admitted to the PACUs at the four selected hospitals following surgery under general, regional, or monitored anesthesia will be included in the study.
연구 유형
등록 (실제)
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia who have signed the informed consent preoperatively will be included in the study.
설명
Inclusion Criteria:
- All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia
Exclusion Criteria:
- Patients who are taken directly to the ICU, ward, discharged, or transferred immediately after surgery.
- Patients who do not provide informed consent for enrollment in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Patients admitted to the postanesthesia care unit
Adult patients admitted to the postanesthesia care unit following surgery under general, regional, or monitored anesthesia |
Patients will be followed up to find out any of these complications: pulmonary, hemodynamic complications, temperature disturbances, or pain
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Rate of patients with postoperative complications in the postanesthesia care unit
기간: 8 postoperative hours
|
Patients will be followed up during their stay in the PACU looking for the appearance of respiratory and hemodynamic complications, temperature disturbances or pain |
8 postoperative hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ataklti Adhanom, MD, Mekelle University
- 수석 연구원: Sirak Worku, MD, Haramaya University
- 수석 연구원: Badhaasaa Beyene, MD, Haramaya University
- 수석 연구원: Ruth Desta, MD, Haramaya University
- 수석 연구원: Edosa Kejela, MD, Jimma University
- 수석 연구원: Fekrey Berhe Gebru, MD, Mekelle University
- 수석 연구원: Frtuna Zeray, MD, Mekelle University
- 수석 연구원: Aemero Awoke, MD, Jimma University
- 수석 연구원: Teklay Tesfay, MD, Mekelle University
- 수석 연구원: Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- MU-IRB 2418/2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD used in the results publication will be shared.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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