Prevalence of Post Anesthesia Care Unit Complications and Associated Factors

NCT06815510 | Recruiting

• 1 other identifier: MU-IRB 2418/2024
• Study Type: observational
• Target: 1,532
• Locations: 2 countries
• Sites: 4

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.

Conditions

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

Keywords

postoperative complications; postanesthesia care unit

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Questionnaire and Physical Exam DIAGNOSTIC_TEST

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

Also known as: Postoperative complications in the PACU

Patients admitted to the postanesthesia care unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All patients admitted to the Post-Anesthesia Care Units (PACUs) following surgery under general, regional, or monitored anesthesia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ángel Becerra-Bolaños, MD PhD: lead
• Mekelle University: collaborator
• Jimma University: collaborator
• Haramaya Unversity: collaborator

Study Sites (4)

Haramaya University

Harar, Ethiopia

RECRUITING

Jimma University

Jimma, Ethiopia

RECRUITING

Mekelle University

Mek'ele, Ethiopia

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ataklti Adhanom, MD

CONTACT

+251925454110; atakltiadhanom12@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 24, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 1, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

ES (1); ET (3)