Clinical trial NCT06815510: Prevalence of Post Anesthesia Care Unit Complications and Associated Factors
Official title: Multicentral Observational Prospective Study on Prevalence of Post Anesthesia Care Unit Complications and Associated Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Care
Complications of Surgical Procedures or Medical Care
Inpatients
Ethiopia
Multicenter Prospective Study
Keywords: postoperative complications
postanesthesia care unit
Lead sponsor: Dr. Negrin University Hospital
Sponsor class: OTHER
Collaborators: name: Mekelle University
name: Jimma University
name: Haramaya Unversity
First posted: 2025-02-07
Enrollment: 1532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients with postoperative complications in the postanesthesia care unit
timeFrame: 8 postoperative hours
Secondary outcomes:
Other outcomes:
Locations:
city: Harar
country: Ethiopia
facility: Haramaya University
city: Jimma
country: Ethiopia
facility: Jimma University
city: Mekelle
country: Ethiopia
facility: Mekelle University
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
Study officials:
affiliation: Mekelle University
name: Ataklti Adhanom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haramaya University
name: Sirak Worku, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haramaya University
name: Badhaasaa Beyene, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haramaya University
name: Ruth Desta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jimma University
name: Edosa Kejela, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Gran Canaria Doctor Negrín
name: Ángel Becerra-Bolaños, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mekelle University
name: Fekrey Berhe Gebru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mekelle University
name: Frtuna Zeray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jimma University
name: Aemero Awoke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mekelle University
name: Teklay Tesfay, MD
role: PRINCIPAL_INVESTIGATOR
References: