Prevalence of Post Anesthesia Care Unit Complications and Associated Factors

NCT ID: NCT06815510

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1532 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-24
• Study Completion Date: 2025-07-01

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.

Conditions

Postoperative Care; Complications of Surgical Procedures or Medical Care; Inpatients; Ethiopia; Multicenter Prospective Study

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients admitted to the postanesthesia care unit

Adult patients admitted to the postanesthesia care unit following surgery under general, regional, or monitored anesthesia

Questionnaire and Physical Exam

Intervention Type: DIAGNOSTIC_TEST

Patients will be followed up to find out any of these complications: pulmonary, hemodynamic complications, temperature disturbances, or pain

Interventions

Questionnaire and Physical Exam

Patients will be followed up to find out any of these complications: pulmonary, hemodynamic complications, temperature disturbances, or pain

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Postoperative complications in the PACU

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mekelle University

OTHER

Sponsor Role: collaborator

Jimma University

OTHER

Sponsor Role: collaborator

Haramaya Unversity

OTHER

Sponsor Role: collaborator

Ángel Becerra-Bolaños, MD PhD

OTHER

Sponsor Role: lead

Responsible Party

Ángel Becerra-Bolaños, MD PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aemero Awoke, MD

Role: PRINCIPAL_INVESTIGATOR

Jimma University

Teklay Tesfay, MD

Role: PRINCIPAL_INVESTIGATOR

Mekelle University

Ataklti Adhanom, MD

Role: PRINCIPAL_INVESTIGATOR

Mekelle University

Sirak Worku, MD

Role: PRINCIPAL_INVESTIGATOR

Haramaya University

Badhaasaa Beyene, MD

Role: PRINCIPAL_INVESTIGATOR

Haramaya University

Ruth Desta, MD

Role: PRINCIPAL_INVESTIGATOR

Haramaya University

Edosa Kejela, MD

Role: PRINCIPAL_INVESTIGATOR

Jimma University

Ángel Becerra-Bolaños, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Gran Canaria Doctor Negrín

Fekrey Berhe Gebru, MD

Role: PRINCIPAL_INVESTIGATOR

Mekelle University

Frtuna Zeray, MD

Role: PRINCIPAL_INVESTIGATOR

Mekelle University

Locations

Haramaya University

Harar, , Ethiopia

Site Status: RECRUITING

Jimma University

Jimma, , Ethiopia

Site Status: RECRUITING

Mekelle University

Mek'ele, , Ethiopia

Site Status: RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, , Spain

Site Status: RECRUITING

Countries

Ethiopia; Spain

Central Contacts

Ataklti Adhanom, MD

Role: CONTACT

atakltiadhanom12@gmail.com

+251925454110

Other Identifiers

MU-IRB 2418/2024

Identifier Type: -

Identifier Source: org_study_id