Prevalence of Post Anesthesia Care Unit Complications and Associated Factors

Multicentral Observational Prospective Study on Prevalence of Post Anesthesia Care Unit Complications and Associated Factors

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Care; Inpatients; Multicenter Prospective Study; Complications of Surgical Procedures or Medical Care; Ethiopia
• Intervention / Treatment: Diagnostic test: Questionnaire and Physical Exam

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.

• Study Type: Observational
• Enrollment (Estimated): 1532

Contacts and Locations

• Study Contact: Name: Ataklti Adhanom, MD; Phone Number: +251925454110; Email: atakltiadhanom12@gmail.com

Study Locations

• Ethiopia
  • Harar, Ethiopia
    • Recruiting
    • Haramaya University
  • Jimma, Ethiopia
    • Recruiting
    • Jimma University
  • Mekelle, Ethiopia
    • Recruiting
    • Mekelle University
• Spain
  • Las Palmas de Gran Canaria, Spain
    • Recruiting
    • Hospital Universitario de Gran Canaria Doctor Negrín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients admitted to the postanesthesia care unit; Adult patients admitted to the postanesthesia care unit following surgery under general, regional, or monitored anesthesia	Diagnostic test: Questionnaire and Physical Exam; Patients will be followed up to find out any of these complications: pulmonary, hemodynamic complications, temperature disturbances, or pain; Other Names: Postoperative complications in the PACU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with postoperative complications in the postanesthesia care unit	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

Collaborators and Investigators

• Sponsor: Ángel Becerra-Bolaños, MD PhD
• Collaborators: Jimma University; Haramaya Unversity; Mekelle University
• Investigators: Principal Investigator: Ataklti Adhanom, MD, Mekelle University; Principal Investigator: Sirak Worku, MD, Haramaya University; Principal Investigator: Badhaasaa Beyene, MD, Haramaya University; Principal Investigator: Ruth Desta, MD, Haramaya University; Principal Investigator: Edosa Kejela, MD, Jimma University; Principal Investigator: Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín; Principal Investigator: Fekrey Berhe Gebru, MD, Mekelle University; Principal Investigator: Frtuna Zeray, MD, Mekelle University; Principal Investigator: Aemero Awoke, MD, Jimma University; Principal Investigator: Teklay Tesfay, MD, Mekelle University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: postoperative complications; postanesthesia care unit
• Other Study ID Numbers: MU-IRB 2418/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD used in the results publication will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No