Surgical Site InfectionsVENTI-MBOUONCT07034573
Evaluation of a Ventilation-filtration System for Operating Rooms at the Protestant Hospital of Mbouo (VENTI-MBOUO)
An observational study of Surgical Site Infections and Infections, run by Christian Doll at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infections, Infections
- What is being tested?
- context adapted air filtration system for operating theatre
- How many people
- 1 participants
- Where
- 1 siteCameroon
- Study dates
- 29 May 2024to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- No patients, only a technical/microbial assessment of the ventilation-filtration system in the operating theatre, with no contact with patients; therefore no source population and no inclusion criteria
Who cannot join
- No patients, only a technical/microbial assessment of the ventilation-filtration system in the operating theatre, with no contact with patients; therefore no source population and no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Performance of the Ventilation-filtration System for Operating Rooms at the Protestant Hospital of Mbouo-Bandjoun (VENTI-MBOUO)
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.
Read more
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.
Read the detailed description
Abstract
The research project is entitled "Evaluation of the performance of the ventilation-filtration system for operating rooms at the Protestant Hospital of Mbouo-Bandjoun (VENTI-MBOUO)".
This research project evaluates an air filtration system supposedly adapted to the context, assumed to be very effective and at low cost. This operating theater air filtration system has been used at Mbouo-Bandjoun hospital for almost 4 years, without any incident problems having been recorded so far.
In this proposed research project, only the filtration-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, microbiological data will be collected prospectively in May 2024, without contact with the patient.
Introduction: Clean air in the operating theatre (OT) is crucial for safe surgery, to prevent surgical site infections. Air filtration devices are standard in most OT as required by international guidelines and regulations. However in low-ressource settings, common air filtration devices are only scarcely found in OT, mainly due to high cost; context-adapted low-cost solutions are urgently needed but not available.
Methods: A low-cost, supposedly high-efficient air filtration device was developed, adapted to the low-resource setting of a district hospital in Cameroon (l'Hôpital Protestant de Mbouo), constructed locally and implemented in 2019. An evaluation was done after nearly 4 years of regular use.
Variables to be evaluated:
Retrospectivey: The particle count in the operating room. Necessary maintenance in the last 3 years. Air velocity, air pressure, air direction in the operating room and in the air filtration device.
Prospectively: Changes in microbial air contamination in the operating room after turning on the device (during idle time, without any patient contact)
- Introduction Surgical site infections (SSIs) are a significant health problem in low- and middle-income countries, leading to increased costs, prolonged hospital stays and disabilities. Up to one-third of patients undergoing surgery in Africa may be affected by SSI. One of the measures for preventing SSI is mechanical air filtration in operating theatres (OTs), which is the most commonly used method for purifying air in OTs in high-income countries. The two main mechanical filtration systems are turbulent mixed airflow ventilation and laminar airflow ventilation. These 'standard' systems in OT in high-income countries are expensive, often exceeding €50,000 in installation costs. This high cost may be an important reason why mechanical air filtration systems are not a common standard in low- and middle-income countries. Due to budget constraints, hospitals with limited resources may prefer simple air conditioning systems that are not suitable for use in OT or simply window ventilation, resulting in high bacterial loads in OT air. Context-appropriate solutions for clean air in OT in low-resource settings are therefore urgently needed. To our knowledge, this pilot study is the first in the world to evaluate a low-cost mechanical air filtration system that is believed to be highly effective and context-appropriate for OT in low-resource settings. This operating theatre air filtration system has been in use at the Mbouo-Bandjoun Hospital for almost four years, with no incidents reported to date. In this proposed research project, only the ventilation-filtration system will be tested technically and microbiologically; no research will be conducted directly on patients or with patient participation. Therefore, the research project should not have any impact on patients. Technical test data will be evaluated retrospectively, and microbiological data will be collected prospectively in May 2024, without contact with patients.
- Research question (if applicable) What are the technical characteristics of the air ventilation-filtration system in the operating theatre of the Protestant Hospital in Mbouo? How effective is the ventilation-filtration system in reducing physical particles and microbiological contamination?
- Research hypothesis(es) (if applicable)
- Study objectives 4.1. General objective To evaluate the ventilation-filtration system in the operating theatre at the Protestant Hospital in Mbouo 4.2. Specific objectives
- To evaluate the technical details of this system, including its particle filtration efficiency 2. To evaluate the reduction in microbes in the operating theatre achieved by this system 3. To compare the performance of this system with international standards
- Conditions
- Surgical Site Infections, Infections
- Being tested
- context adapted air filtration system for operating theatre
- Keywords
- operating theatre, mechanical ventilation, air filtration, low resource context
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
context adapted air filtration system for operating theatreOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: Other: context adapted air filtration system for operating theatre |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of particles in the operating room air
The number of particles in the operating room air (particles per litre of air). Retrospective variable.
Measured: retrospective: 4 years before study start
maintenance frequency
Maintenance of the ventilation-filtration system carried out over the last 4 years (frequency). Retrospective variable
Measured: retrospective: 4 years before study start
system breakdowns
Number of system breakdowns. Retrospective variable
Measured: 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
Measured: retrospective: 4 years before study start
air pressure
air pressure (kPa) in the operating theatre and in the air filtration system.Retrospective variable
Measured: 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
Measured: prospective: 29 april to 31 april 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start29 May 2024
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Doll
- Sponsor type
- University, hospital or other
- Collaborators
- Universite Evangelique du Cameroun, Paix et Santé - Gesundheit und Frieden global e.V.
- Responsible party
- Sponsor-investigator, Christian Doll, Universite Evangelique du Cameroun
- Investigators
- Christian Doll, Dr., Principal investigator, Hessing Stiftung Orthopädische Fachkliniken
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034573
- Sponsor's protocol ID
- VENTI-MBOUO
- Acronym
- VENTI-MBOUO
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie the results reported (after deidentification) will be available beginning immediately after the article publication and ending 24 months after article publication. 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.
Publications
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.
PubMed 22542026Pereira 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.
PubMed 32069790Zhang 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.
PubMed 32076617Doll CL, Opalka R, Tchamo Nguifo L, Tamuedjoun Talom A, Kuate Kamdem L, Will A, Johannsen L, Geiger F, Trampuz A. How to get cheap clean air? Implementation of an affordable high-efficient air filtration ventilation system for operating theatres in a low-resource setting. GMS Hyg Infect Control. 2026 Jan 12;21:Doc06. doi: 10.3205/dgkh000615. eCollection 2026.
PubMed 41716972
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance of the Ventilation-filtration System for Operating Rooms at the Protestant Hospital of Mbouo-Bandjoun (VENTI-MBOUO)
- ClinicalTrials.gov ID
- NCT07034573
- Acronym / sponsor ID
- VENTI-MBOUO / VENTI-MBOUO
- Conditions
- Surgical Site Infections, Infections
- Keywords
- operating theatre, mechanical ventilation, air filtration, low resource context
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Christian DollUniversity, hospital or other
- Collaborators
- Universite Evangelique du Cameroun, Paix et Santé - Gesundheit und Frieden global e.V.
- Study start
- 29 May 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Abstract
The research project is entitled "Evaluation of the performance of the ventilation-filtration system for operating rooms at the Protestant Hospital of Mbouo-Bandjoun (VENTI-MBOUO)".
This research project evaluates an air filtration system supposedly adapted to the context, assumed to be very effective and at low cost. This operating theater air filtration system has been used at Mbouo-Bandjoun hospital for almost 4 years, without any incident problems having been recorded so far.
In this proposed research project, only the filtration-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, microbiological data will be collected prospectively in May 2024, without contact with the patient.
Introduction: Clean air in the operating theatre (OT) is crucial for safe surgery, to prevent surgical site infections. Air filtration devices are standard in most OT as required by international guidelines and regulations. However in low-ressource settings, common air filtration devices are only scarcely found in OT, mainly due to high cost; context-adapted low-cost solutions are urgently needed but not available.
Methods: A low-cost, supposedly high-efficient air filtration device was developed, adapted to the low-resource setting of a district hospital in Cameroon (l'Hôpital Protestant de Mbouo), constructed locally and implemented in 2019. An evaluation was done after nearly 4 years of regular use.
Variables to be evaluated:
Retrospectivey: The particle count in the operating room. Necessary maintenance in the last 3 years. Air velocity, air pressure, air direction in the operating room and in the air filtration device.
Prospectively: Changes in microbial air contamination in the operating room after turning on the device (during idle time, without any patient contact)
- Introduction Surgical site infections (SSIs) are a significant health problem in low- and middle-income countries, leading to increased costs, prolonged hospital stays and disabilities. Up to one-third of patients undergoing surgery in Africa may be affected by SSI. One of the measures for preventing SSI is mechanical air filtration in operating theatres (OTs), which is the most commonly used method for purifying air in OTs in high-income countries. The two main mechanical filtration systems are turbulent mixed airflow ventilation and laminar airflow ventilation. These 'standard' systems in OT in high-income countries are expensive, often exceeding €50,000 in installation costs. This high cost may be an important reason why mechanical air filtration systems are not a common standard in low- and middle-income countries. Due to budget constraints, hospitals with limited resources may prefer simple air conditioning systems that are not suitable for use in OT or simply window ventilation, resulting in high bacterial loads in OT air. Context-appropriate solutions for clean air in OT in low-resource settings are therefore urgently needed. To our knowledge, this pilot study is the first in the world to evaluate a low-cost mechanical air filtration system that is believed to be highly effective and context-appropriate for OT in low-resource settings. This operating theatre air filtration system has been in use at the Mbouo-Bandjoun Hospital for almost four years, with no incidents reported to date. In this proposed research project, only the ventilation-filtration system will be tested technically and microbiologically; no research will be conducted directly on patients or with patient participation. Therefore, the research project should not have any impact on patients. Technical test data will be evaluated retrospectively, and microbiological data will be collected prospectively in May 2024, without contact with patients.
- Research question (if applicable) What are the technical characteristics of the air ventilation-filtration system in the operating theatre of the Protestant Hospital in Mbouo? How effective is the ventilation-filtration system in reducing physical particles and microbiological contamination?
- Research hypothesis(es) (if applicable)
- Study objectives 4.1. General objective To evaluate the ventilation-filtration system in the operating theatre at the Protestant Hospital in Mbouo 4.2. Specific objectives
- To evaluate the technical details of this system, including its particle filtration efficiency 2. To evaluate the reduction in microbes in the operating theatre achieved by this system 3. To compare the performance of this system with international standards
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No patients, only a technical/microbial assessment of the ventilation-filtration system | – | Other: context adapted air filtration system for operating theatreNo 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" |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- No patients, only a technical/microbial assessment of the ventilation-filtration system in the operating theatre, with no contact with patients; therefore no source population and no inclusion criteria
Key exclusion criteria (1 listed)
- No patients, only a technical/microbial assessment of the ventilation-filtration system in the operating theatre, with no contact with patients; therefore no source population and no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| context adapted air filtration system for operating theatreThis 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. | Other | No patients, only a technical/microbial assessment of the ventilation-filtration system |
Primary outcome
number of particles in the operating room air
Time frame: retrospective: 4 years before study start
The number of particles in the operating room air (particles per litre of air). Retrospective variable.
maintenance frequency
Time frame: retrospective: 4 years before study start
Maintenance of the ventilation-filtration system carried out over the last 4 years (frequency). Retrospective variable
system breakdowns
Time frame: retrospective: 4 years before study start
Number of system breakdowns. Retrospective variable
air speed and direction
Time frame: retrospective: 4 years before study start
Air speed (m/s) and air direction in the operating theatre and in the air filtration system.Retrospective variable
air pressure
Time frame: retrospective: 4 years before study start
air pressure (kPa) in the operating theatre and in the air filtration system.Retrospective variable
microbial air contamination
Time frame: prospective: 29 april to 31 april 2024
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 22542026Hirsch 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.
- Background: PubMed 32069790Pereira 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.
- Background: PubMed 32076617Zhang 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.
- Results publication: PubMed 41716972Doll CL, Opalka R, Tchamo Nguifo L, Tamuedjoun Talom A, Kuate Kamdem L, Will A, Johannsen L, Geiger F, Trampuz A. How to get cheap clean air? Implementation of an affordable high-efficient air filtration ventilation system for operating theatres in a low-resource setting. GMS Hyg Infect Control. 2026 Jan 12;21:Doc06. doi: 10.3205/dgkh000615. eCollection 2026.
- Individual participant dataSharing planned: Yes. IPD that underlie the results reported (after deidentification) will be available beginning immediately after the article publication and ending 24 months after article publication. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Doll, Dr. principal investigator
Hessing Stiftung Orthopädische Fachkliniken
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infections and Infections, run by Christian Doll at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of particles in the operating room air (time frame: retrospective: 4 years before study start). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07034573, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.