Infection ControlNCT02944695
Audit of Bronchoscopy Practice in Egypt: Adherence to Safety and Infection Control Guidelines
An observational study of Infection Control, run by Assiut University at 1 site in Egypt.
Trial summary
Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infection Control
- What is being tested?
- audit
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Aug 2020
- 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: Bronchoscopy Units personnel: Physicians- Nurses-workers
Who may be able to join
- Bronchoscopy Units personnel
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Pulmonology Departments
Asyut, 71111
Aliae Mohamed-Hussein, 882413711, massah_99@yahoo.com
About this study
Official title: Adherence to Safety and Infection Control Guideline in Bronchoscopy Units
Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure.
Read the detailed description
Adequate facilities, manpower and training are also essential. Staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. An audit well be carried out of bronchoscopy procedures in hospitals in the Egypt and the findings well be compared with published guidelines on good practice and clinical consensus
- Conditions
- Infection Control
- Being tested
- audit
- Keywords
- audit, infection control, bronchoscopy unit, Egypt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auditOther
Practice adherence to guidelines
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adherence to guidelines on disinfection procedures and patient monitoring
Measured: 3 months
Secondary outcomes (1)
self- administered questionnaire
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection ControlStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
- Investigators
- Aliae Mohamed-Hussein, MD, Study chair, Professor of Pulmonology- Faculty of Medicine-Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944695
- Sponsor's protocol ID
- AssiutU1
- Status last verified
- Mar 2020
- First submitted
- 22 Oct 2016
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Safety and Infection Control Guideline in Bronchoscopy Units
- ClinicalTrials.gov ID
- NCT02944695
- Acronym / sponsor ID
- AssiutU1
- Conditions
- Infection Control
- Keywords
- audit, infection control, bronchoscopy unit, Egypt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure.
Detailed description
Adequate facilities, manpower and training are also essential. Staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. An audit well be carried out of bronchoscopy procedures in hospitals in the Egypt and the findings well be compared with published guidelines on good practice and clinical consensus
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Bronchoscopy Units personnel: Physicians- Nurses-workers
Key inclusion criteria (1 listed)
- Bronchoscopy Units personnel
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| auditPractice adherence to guidelines | Other | – |
Primary outcome
Assessment of adherence to guidelines on disinfection procedures and patient monitoring
Time frame: 3 months
1 secondary outcome
self- administered questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Aliae Mohamed-Hussein, MD study chair
Professor of Pulmonology- Faculty of Medicine-Assiut University
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 Infection Control, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 2 Apr 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliae AR Mohamed-Hussein (+201222302352, aliaehussein@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adherence to guidelines on disinfection procedures and patient monitoring (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2020.