Evaluation of a Ventilation-filtration System for Operating Rooms at the Protestant Hospital of Mbouo (VENTI-MBOUO)

NCT07034573 | Completed

• 1 other identifier: VENTI-MBOUO
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This research project is evaluating an air filtration system that is supposed to be adapted to the context, highly efficient and affordable. This air filtration system for operating theatres has been in use at Mbouo-Bandjoun hospital in Cameroon since 2019, with no incidents recorded to date. In this proposed research project, only the ventilation system will be tested technically and microbiologically; no research will be carried out directly on patients or with patient participation. Therefore, the research project is not expected to have any impact on patients. Technical test data will be evaluated retrospectively, while microbiological data will be collected prospectively without patient contact. The air filtration system was installed in the OT of the Protestant hospital Mbouo (Hôpital Protestant de Mbouo) in 2019. Before the installation of the air filtrations system, the OT used window-based ventilation which seems, besides wall-mounted air conditioning systems, quite common in OT in Cameroonian hospitals. The air filtrations system has been in regular use for 3.5 years before the first maintenance could be performed, due to COVID travel restrictions. This maintenance and technical measurement took place in November 2023. Microbial samples in the OT were collected in Mai 2024. The data of the maintenance and technical measurements of the air filtration system are retrospectively used for this study. The parameters that are extracted from the maintenance documents are: particle counts, temperature, humidity, air velocity and pressure differences at various measurement points inside and outside the OT as well as inside the air filtration device. To study the microbial burden in the OT, a prospective evaluation was carried out: In a time slot when no surgical procedures were planned, a passive sampling with settling plates was carried out.

Conditions

Surgical Site Infections; Infections

Keywords

operating theatre; mechanical ventilation; air filtration; low resource context

Outcome Measures

Primary Outcomes (6)

• number of particles in the operating room air

  The number of particles in the operating room air (particles per litre of air). Retrospective variable.

  retrospective: 4 years before study start

• maintenance frequency

  Maintenance of the ventilation-filtration system carried out over the last 4 years (frequency). Retrospective variable

  retrospective: 4 years before study start

• system breakdowns

  Number of system breakdowns. Retrospective variable

  retrospective: 4 years before study start

• air speed and direction

  Air speed (m/s) and air direction in the operating theatre and in the air filtration system.Retrospective variable

  retrospective: 4 years before study start

• air pressure

  air pressure (kPa) in the operating theatre and in the air filtration system.Retrospective variable

  retrospective: 4 years before study start

• microbial air contamination

  Changes in microbial contamination of the air in the operating theatre after the ventilation-air filtration system was switched on, during periods of inactivity in the operating theatre, without any contact with the patient (colony-forming units per Petri dish).Prospective variable

  prospective: 29 april to 31 april 2024

Study Arms (1)

No patients, only a technical/microbial assessment of the ventilation-filtration system

No patients, only a technical/microbial assessment of the ventilation-filtration system in the operating theatre, with no contact with patients; therefore no "participant group/cohort"

Other: context adapted air filtration system for operating theatre

Interventions

context adapted air filtration system for operating theatre OTHER

This observational pilot study combines a retrospective design (technical data) and a prospective design (microbial data) to evaluate a new air filtration system adapted to the context. For this research, the technical data of the system concerning air velocity, temperature, etc. will be used retrospectively. Microbial sampling in the operating theatre will be carried out prospectively. No patient contact will take place.

No patients, only a technical/microbial assessment of the ventilation-filtration system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No patients, only a technical/microbial assessment of the ventilation-filtration system in the operating theatre, with no contact with patients; therefore no study population

Sponsors & Collaborators

• Christian Doll: lead
• Universite Evangelique du Cameroun: collaborator
• Paix et Santé - Gesundheit und Frieden global e.V.: collaborator

Study Sites (1)

Mbouo Protestant Hospital

Bafoussam, Cameroon

Location

Related Publications (3)

• Hirsch T, Hubert H, Fischer S, Lahmer A, Lehnhardt M, Steinau HU, Steinstraesser L, Seipp HM. Bacterial burden in the operating room: impact of airflow systems. Am J Infect Control. 2012 Sep;40(7):e228-32. doi: 10.1016/j.ajic.2012.01.007. Epub 2012 Apr 26.

  PMID: 22542026 BACKGROUND

• Pereira M, Tribess A, Buonanno G, Stabile L, Scungio M, Baffo I. Particle and Carbon Dioxide Concentration Levels in a Surgical Room Conditioned with a Window/Wall Air-conditioning System. Int J Environ Res Public Health. 2020 Feb 13;17(4):1180. doi: 10.3390/ijerph17041180.

  PMID: 32069790 BACKGROUND

• Zhang B, Li L, Yao X, Gong Y, Zhang Y, Yang H, Li W, Lin L, Yang Y, Zhang H, Jia H. Analysis of Air Purification Methods in Operating Rooms of Chinese Hospitals. Biomed Res Int. 2020 Feb 1;2020:8278943. doi: 10.1155/2020/8278943. eCollection 2020.

  PMID: 32076617 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Interventions

Operating Rooms

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Christian Doll, Dr.

  Hessing Stiftung Orthopädische Fachkliniken

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 24, 2025
• Study Start: May 29, 2024
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: for 24 months after article publication
• Access Criteria: The data will be shared to researchers that provide a methodologically sound proposal, to achieve aims in the approved proposal. Corresponding author should be contacted.

Locations

CA (1)