Ventilator Associated PneumoniaNCT05517759
Application of VAP Bundle Among ICU Nurses
An observational study of Ventilator Associated Pneumonia, run by University of Bahrain at 1 site in Bahrain.
Trial summary
Background: Ventilator associated pneumonia (VAP) is a recognized healthcare-associated infection in lungs parenchyma that occurs in patients in which they are connected to mechanical ventilator. And this infection will occur after completing 48 hours of connection to the ventilator. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Educational program
- How many people
- 58 participants
- Where
- 1 siteBahrain
- Study dates
- 2 Sep 2020to 1 Feb 2021
- 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 20 to 60 years
- All sexes
- Adult
Study population: population was all nurses from both gender and all age with different years of experience and different Level of education. nurse are working in Salmaniya medical complex (SMC) (which is one of the main governmental hospitals in Bahrain that provide secondary and tertiary care for the citizen) and taking care of patients connected to mechanical ventilator at intensive care unit ICU
Who may be able to join
- all permanent ICU nurse who assigned to mechanically ventilated patients and willing to participate in the three phases of the study
Who cannot join
- Nurse who are not willing to participate and nurses who are not willing to reach the three phases of the study and ICU nurses who been taken to serve in COVID facilities and not available in Main SMC ICU during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Ventilator-Associated Pneumonia Prevention Bundle Among ICU Nurses in Salmaniya Medical Complex, Bahrain: A Quasi-Experimental Study
Background: Ventilator associated pneumonia (VAP) is a recognized healthcare-associated infection in lungs parenchyma that occurs in patients in which they are connected to mechanical ventilator. And this infection will occur after completing 48 hours of connection to the ventilator.
Aim study aims to evaluate the effect of implementing VAP prevention bundle training program on nurses' knowledge and compliance among nurses in intensive care unit in Salmaniya Medical complex in Bahrain.
Methodology: A quantitative quasi- experimental study was conducted in the main ICU of Salmaniya Medical complex in Bahrain. Purposive sampling technique was used, and 58 ICU staff nurses were enrolled at data collection period. Tools used for data collection was a self-administrative questionnaire to assess ICU nurses' knowledge and observational checklist was used to assess their compliance. Data were analyzed with descriptive and inferential statistics
Read the detailed description
nurses were approach individually to introduce the researcher and the study objectives to them once the nurse agreed to participate in the study an informed consent was given with a contact details provided to the participants including direct researcher email and researches advisor email beside to that a special direct contact number with a what's up for the participants was given to facilitate the reach to the researcher at any time if they got any doubts. After that, compliance to the VAP bundle was evaluated to determine the current status. Participants were given a multiple-choice knowledge questionnaire to assess their knowledge and researcher was observing them during the filling period to prevent using their smart phone for searching or to avoid sharing answers between them. After that the VAP bundle implementation by nurses was observed following checklists by the researcher herself and no changes was be implanted
then the nursing stuff were educated all over the three shifts about VAP bundle throughout an educational package and the schedule of teaching session was arranged with nursing supervisor at ICU to not disturb the sequence of the work timetable. Nurses received extensive educational course in a creative way. At the early beginning of this stage a banner contains VAP bundle elements size 116cm x 160 was kept Infront of ICU's entering door, this area was chosen to the banner to attracted nurses' attentions at the beginning of the shift and to make the expectation about the education to develop in their mind. Then nurses on the specified shift were divided into two groups based on there workload one group received the lecture and the second group were with patients to avoid work disturbance then the groups were switched. Group discussion, PowerPoint presentation and brain storming questions card were given to the nurses.
then During this phase, a rollup banner size (200cm x 120 cm) contains VAP bundle elements and its benefit was kept near to the nurses station to facilitate remembrance of the elements as will as because ICU at SMC are using the classic way of documentation pens with the study logo of VAP were distributed to the participants to always keep the bundle implementation in their mind, and of course we used the pandemic situation for our benefit by providing the participants N95 and KN95 masks that have a printed logo of our study, this can increase the implementation of the bundle and their adherence if the eyes get used on the logo. As well as during this phase nurse knowledge were reassessed after the intervention by using the same questionnaire that was distributed in the pre phase. the compliance of VAP bundle was monitor by the researcher who observed and record only without interfering to avoid any potential effect on the compliance. Everyday approximately during morning, evening and night shift for several hours was spent in observing nurses performing their routine care activities.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Educational program
- Keywords
- nurses, knowledge, compliance, VAP, VAP bundle, vap prevention bundle, ICU
- Medical subject headings
- Pneumonia, Ventilator-Associated, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programOther
The sessions were delivered in form of face to face, group disscussion, brainstorming and smart cards. The educational package covered all aspect of knowledge regarding VAP such as definitions, risk factors m cause, manifestation, diagnostic criteria, and nursing care to prevent VAP. A PowerPoint and information pamphlet were used to display the material.
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge
nurses knowledge about VAP disease and their knowledge about VAP prevention bundle by using questionnaire adopted from Lan, Lai and Yang (2014) study then Knowledge was categorized as poor average and good by using knowledge cut off point (the knowledge was categorized, using Bloom's cut-off point, as good if the score was between 80 and 100%, moderate if the score was between 60 and 79%, and poor if the score was less than 60%)
Measured: 1 month
compliance
nurses application of VAP bundle elements which are 1. Elevation of the head of the bed (30-45) degree, 2. Daily sedation vacation and assessment of weaning and extubation, 3. Usage of prophylaxis for peptic ulcer disease (PUD), 4. Usage of prophylaxis of deep vein thrombosis (DVT), 5. Oral care daily with chlorhexidine The compliance was recorded daily for each bundle element, if the bundle elements performed it recorded as "yes", whereas if it was missing it was recorded as "No", Observation checklist has been obtained from Institute for Healthcare Improvement and the name of the tool was IHI Ventilator Bundle
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start2 Sep 2020
- Primary completion31 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bahrain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Mohamed Ali Alaswad, University of Bahrain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517759
- Sponsor's protocol ID
- university of Bahrain
- Status last verified
- Aug 2022
- First submitted
- 24 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the participant completes the questionnaires, he or she was asked adherences in an envelope that was be provided by the researcher and seal the envelope, then it was be collected by the researcher only from the unite. And for further confidentiality and anonymity no participant's names was be recorded during data collection and data reporting and the consent forms with the questionnaires was separated at the time of data collection. The data entry to the software's SPSS was done only by the investigator herself in a password protected computer and the physical copies of the questionnaires and other tools was be stored in a locked cupboard and only the researcher and her supervisor have access to the raw data. Once the study will be published and accept to disseminate a professional journal, only the aggregated data will be presented and then the stored data will be discarded
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Ventilator-Associated Pneumonia Prevention Bundle Among ICU Nurses in Salmaniya Medical Complex, Bahrain: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT05517759
- Acronym / sponsor ID
- university of Bahrain
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- nurses, knowledge, compliance, VAP, VAP bundle, vap prevention bundle, ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of BahrainUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 26 Aug 2022 (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.
Background: Ventilator associated pneumonia (VAP) is a recognized healthcare-associated infection in lungs parenchyma that occurs in patients in which they are connected to mechanical ventilator. And this infection will occur after completing 48 hours of connection to the ventilator.
Aim study aims to evaluate the effect of implementing VAP prevention bundle training program on nurses' knowledge and compliance among nurses in intensive care unit in Salmaniya Medical complex in Bahrain.
Methodology: A quantitative quasi- experimental study was conducted in the main ICU of Salmaniya Medical complex in Bahrain. Purposive sampling technique was used, and 58 ICU staff nurses were enrolled at data collection period. Tools used for data collection was a self-administrative questionnaire to assess ICU nurses' knowledge and observational checklist was used to assess their compliance. Data were analyzed with descriptive and inferential statistics
Detailed description
nurses were approach individually to introduce the researcher and the study objectives to them once the nurse agreed to participate in the study an informed consent was given with a contact details provided to the participants including direct researcher email and researches advisor email beside to that a special direct contact number with a what's up for the participants was given to facilitate the reach to the researcher at any time if they got any doubts. After that, compliance to the VAP bundle was evaluated to determine the current status. Participants were given a multiple-choice knowledge questionnaire to assess their knowledge and researcher was observing them during the filling period to prevent using their smart phone for searching or to avoid sharing answers between them. After that the VAP bundle implementation by nurses was observed following checklists by the researcher herself and no changes was be implanted
then the nursing stuff were educated all over the three shifts about VAP bundle throughout an educational package and the schedule of teaching session was arranged with nursing supervisor at ICU to not disturb the sequence of the work timetable. Nurses received extensive educational course in a creative way. At the early beginning of this stage a banner contains VAP bundle elements size 116cm x 160 was kept Infront of ICU's entering door, this area was chosen to the banner to attracted nurses' attentions at the beginning of the shift and to make the expectation about the education to develop in their mind. Then nurses on the specified shift were divided into two groups based on there workload one group received the lecture and the second group were with patients to avoid work disturbance then the groups were switched. Group discussion, PowerPoint presentation and brain storming questions card were given to the nurses.
then During this phase, a rollup banner size (200cm x 120 cm) contains VAP bundle elements and its benefit was kept near to the nurses station to facilitate remembrance of the elements as will as because ICU at SMC are using the classic way of documentation pens with the study logo of VAP were distributed to the participants to always keep the bundle implementation in their mind, and of course we used the pandemic situation for our benefit by providing the participants N95 and KN95 masks that have a printed logo of our study, this can increase the implementation of the bundle and their adherence if the eyes get used on the logo. As well as during this phase nurse knowledge were reassessed after the intervention by using the same questionnaire that was distributed in the pre phase. the compliance of VAP bundle was monitor by the researcher who observed and record only without interfering to avoid any potential effect on the compliance. Everyday approximately during morning, evening and night shift for several hours was spent in observing nurses performing their routine care activities.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- population was all nurses from both gender and all age with different years of experience and different Level of education. nurse are working in Salmaniya medical complex (SMC) (which is one of the main governmental hospitals in Bahrain that provide secondary and tertiary care for the citizen) and taking care of patients connected to mechanical ventilator at intensive care unit ICU
Key inclusion criteria (1 listed)
- all permanent ICU nurse who assigned to mechanically ventilated patients and willing to participate in the three phases of the study
Key exclusion criteria (1 listed)
- Nurse who are not willing to participate and nurses who are not willing to reach the three phases of the study and ICU nurses who been taken to serve in COVID facilities and not available in Main SMC ICU during the study
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 |
|---|---|---|
| Educational programThe sessions were delivered in form of face to face, group disscussion, brainstorming and smart cards. The educational package covered all aspect of knowledge regarding VAP such as definitions, risk factors m cause, manifestation, diagnostic criteria, and nursing care to prevent VAP. A PowerPoint and information pamphlet were used to display the material. | Other | – |
Primary outcome
knowledge
Time frame: 1 month
nurses knowledge about VAP disease and their knowledge about VAP prevention bundle by using questionnaire adopted from Lan, Lai and Yang (2014) study then Knowledge was categorized as poor average and good by using knowledge cut off point (the knowledge was categorized, using Bloom's cut-off point, as good if the score was between 80 and 100%, moderate if the score was between 60 and 79%, and poor if the score was less than 60%)
compliance
Time frame: 1 month
nurses application of VAP bundle elements which are 1. Elevation of the head of the bed (30-45) degree, 2. Daily sedation vacation and assessment of weaning and extubation, 3. Usage of prophylaxis for peptic ulcer disease (PUD), 4. Usage of prophylaxis of deep vein thrombosis (DVT), 5. Oral care daily with chlorhexidine The compliance was recorded daily for each bundle element, if the bundle elements performed it recorded as "yes", whereas if it was missing it was recorded as "No", Observation checklist has been obtained from Institute for Healthcare Improvement and the name of the tool was IHI Ventilator Bundle
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 1 Sep 2022.
- Individual participant dataSharing planned: No. Once the participant completes the questionnaires, he or she was asked adherences in an envelope that was be provided by the researcher and seal the envelope, then it was be collected by the researcher only from the unite. And for further confidentiality and anonymity no participant's names was be recorded during data collection and data reporting and the consent forms with the questionnaires was separated at the time of data collection. The data entry to the software's SPSS was done only by the investigator herself in a password protected computer and the physical copies of the questionnaires and other tools was be stored in a locked cupboard and only the researcher and her supervisor have access to the raw data. Once the study will be published and accept to disseminate a professional journal, only the aggregated data will be presented and then the stored data will be discarded
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ventilator Associated Pneumonia, run by University of Bahrain at 1 site in Bahrain.
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 1 Sep 2022. 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 Bahrain. 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?
knowledge (time frame: 1 month). The study lists 2 primary outcomes in all. 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 1 Sep 2022.