- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06815510
Prävalenz von Komplikationen für Pflegeeinheiten nach Anästhesie und damit verbundenen Faktoren
Multikentrale beobachtende prospektive Studie zur Prävalenz von Komplikationen für Pflegeeinheiten nach Anästhesie und damit verbundenen Faktoren
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rate of patients with postoperative complications in the postanesthesia care unit
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ataklti Adhanom, MD, Mekelle University
- Hauptermittler: Sirak Worku, MD, Haramaya University
- Hauptermittler: Badhaasaa Beyene, MD, Haramaya University
- Hauptermittler: Ruth Desta, MD, Haramaya University
- Hauptermittler: Edosa Kejela, MD, Jimma University
- Hauptermittler: Fekrey Berhe Gebru, MD, Mekelle University
- Hauptermittler: Frtuna Zeray, MD, Mekelle University
- Hauptermittler: Aemero Awoke, MD, Jimma University
- Hauptermittler: Teklay Tesfay, MD, Mekelle University
- Hauptermittler: Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MU-IRB 2418/2024
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
IPD used in the results publication will be shared.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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