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Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia

Primary Purpose

Evidence-based Practices, Nursing Education, Incidence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Evidence-based Practices

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ICU patients intubated mechanical ventilation for more than 48 hours Also, the ICU staff (medical or nurses) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles. Exclusion Criteria: Patients intubated outside the IFH. patients have immunocompromised diseases will be excluded.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

pre-experimental

experimental

Arm Description

assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP

The intervention group of patients will receive the proposed VAP prevention EBP which consists of ten items bundle. also, assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP

Outcomes

Primary Outcome Measures

Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP
VAP incidence will be measured using the diagnostic criteria for clinically defined pneumonia outlined by the Centres for Disease Control and Prevention of the United States (TOOL 1) [3]. The ICU specialist will made a final diagnosis of VAP based on chest imaging test results, clinical signs/symptoms, and laboratory findings. VAP incidence will be measured every day for MV patients using tool 1.

Secondary Outcome Measures

Evaluate the effect of the selected EPB and related nurses' education on the severity of VAP
The severity of VAP will be determined by sequential organ failure assessment (SOFA) scores [9]. During a patient's stay in the intensive care unit (ICU), the SOFA scoring system employs six reproducible variables per organ system to assess the disease's severity. Vincent et al. developed it in 1996 [9]. Each organ system was assigned a score between 0 (normal) and 4 (most abnormal), with a minimum of 0 and a maximum of 24. We will evaluate the SOFA scores for the patients on ICU admission, the first day of MV connection, every day of VAP development, and on ICU discharge (if applicable).
Assess the compliance of ICU staff with implementing VAP prevention bundel as an EBP
VAPPCC is an advanced tool formulated by researchers in terms of the proposed VAP prevention EBP (ten bundle). VAPPCC consists of ten items, including the satisfactory criteria for each item. The ICU staff's compliance for each item ranged from 1 (yes) to 0 (no), with a minimum score of 0 and a maximum of 10. The charge nurse will use VAPPCC to assess the provided care for MV patients daily.

Full Information

First Posted
May 17, 2023
Last Updated
September 12, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05877105
Brief Title
Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia
Official Title
Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course. Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%. Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP Hypothesis: H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care. H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care. Research question: Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP? Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre & post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families. ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently. Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds. Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.
Detailed Description
Background: Invasive mechanical ventilation (MV) is used as a cornerstone in the treatment plan of intensive care units (ICUs) patients to provide adequate tissue oxygenation to support the body during the treatment course. Ventilator-associated pneumonia (VAP) is a preventable iatrogenic complication that can develop in patients undergoing mechanical ventilation. VAP is pneumonia that develops 2 days after endotracheal intubation; the patient must have new or progressive radiological infiltrate, infection alerts (e.g. fever, white blood cell count change), altered sputum characters, and isolation of a causative organism, all together to diagnose VAP. VAP is the most frequent hospital-acquired infection occurring in the ICUs and has a high associated mortality rate. Mortality rate for VAP ranges from 24-51%. Therefore, this study aims to evaluate the VAP preventive effect of the selected EPB and related nurses' education on the incidence and severity of VAP, as well as assess the nurses' compliance with the selected VAP preventive EBP Hypothesis: H1: Implementation of VAP prevention EBP and related nurses' education would reduce the incidence of VAP among mechanically ventilated patients compared to those receiving conventional care. H2: Implementation of VAP prevention EBP and related nurses' education would reduce the severity of VAP among mechanically ventilated patients compared to those receiving conventional care. Research question: Q1: What level of compliance do ICU staff have with implementing of VAP prevention EBP? Trial design The current study will utilize a prospective, longitudinal, single-arm design, pre & post-experimental. The research's purpose, risks, and potential benefits will be explained to all participants before their voluntary consent and recruitment into the study. Participation was completely voluntary, and written informed consent was obtained from all participants or their families. ICU nurses will receive tutorial sessions, including four hours of theory and six hours of clinical training in the clinical setting. The tutorial sessions will cover the proper implementation of ten VAP preventive bundles as an EVB. The clinical training will use a demonstration and redemonstration approach to learning to ensure that they understand and can implement the ten VAP preventive bundles efficiently. Participants sample and setting The study will be held at the ICU of the National Hepatology and Tropical Medicine Research Institute (Imbaba Fever Hospital) (NHTMRI-IFH), Giza, Egypt. The total capacity of the ICUs is 20 beds. Regards to the ICU patients, 72 patients estimated by G power software V.3.1.9.4 (Psychonomic Society, Madison, Wisconsin, USA) with α = 0.05, power (1-β err prob) = 0.80, and effect size = 0.6. Also, eight participants will be added as anticipated dropout during the time of data collection. Hence the total targeted sample size will be 80 patients (40 in each group). Also, all ICU staff (nurses and doctors) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles. Data collection procedure After obtaining ethical and administrative approval, informed consent will be obtained from eligible patients. The pre-experimental phase will be started by assessing VAP incidence and severity among the participating MV patients using tools 1 and 2, as well as ICU staff compliance to implement the VAP preventive bundle utilizing tool 3 as baseline data for 30-40 days. After finishing the pre-assessment, the following week will be considered washing time before starting the post-experimental time to ensure that all pre-assessment patients are discharged. During the washing time, the nurses will receive a tutorial session on how to implement the adopted VAP preventive bundle, and then the medical and nursing staff will start implementing the VAP preventive bundle in the post-experimental phase for 30-40 days. Tools 1, 2, and 3 will be utilized to evaluate VAP incidence, severity, and ICU staff compliance to implement the VAP preventive bundle. All data will be collected in an Excel sheet for potential statistical analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evidence-based Practices, Nursing Education, Incidence, Ventilator-associated Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
certain VAP bundle as an evidence-based practice will be implemented as the intervention also the needed related nursing education will be given to ensure that the intervention will be implemented properly, and we will examine its effect on VAP incidence and severity among the intervention group as a dependent variable; then, we will compare the finding against the comparative no intervention group who receives the traditional care. Two arms (intervention and non-intervention comparative groups)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pre-experimental
Arm Type
No Intervention
Arm Description
assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP
Arm Title
experimental
Arm Type
Experimental
Arm Description
The intervention group of patients will receive the proposed VAP prevention EBP which consists of ten items bundle. also, assessment of MV patients for VAP incidence and severity ICU staff for will be assessed for Compliance with implementing VAP prevention EBP
Intervention Type
Other
Intervention Name(s)
Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle
Intervention Description
VAP prevention EBP which consists of ten items bundle; hand hygiene, head-of-bed elevation, oral care with cetylpyridinium chloride, avoidance of oversedation, proper breathing circuit management, appropriate maintenance of endotracheal tube cuff pressure, closed system and subglottic suctioning, daily assessment for extubation, early ambulation and rehabilitation, and peptic ulcer and deep vein thrombosis (DVT) prophylaxis.
Primary Outcome Measure Information:
Title
Evaluate the effect of the selected EPB and related nurses' education on the incidence VAP
Description
VAP incidence will be measured using the diagnostic criteria for clinically defined pneumonia outlined by the Centres for Disease Control and Prevention of the United States (TOOL 1) [3]. The ICU specialist will made a final diagnosis of VAP based on chest imaging test results, clinical signs/symptoms, and laboratory findings. VAP incidence will be measured every day for MV patients using tool 1.
Time Frame
35-40 days
Secondary Outcome Measure Information:
Title
Evaluate the effect of the selected EPB and related nurses' education on the severity of VAP
Description
The severity of VAP will be determined by sequential organ failure assessment (SOFA) scores [9]. During a patient's stay in the intensive care unit (ICU), the SOFA scoring system employs six reproducible variables per organ system to assess the disease's severity. Vincent et al. developed it in 1996 [9]. Each organ system was assigned a score between 0 (normal) and 4 (most abnormal), with a minimum of 0 and a maximum of 24. We will evaluate the SOFA scores for the patients on ICU admission, the first day of MV connection, every day of VAP development, and on ICU discharge (if applicable).
Time Frame
35-40 days
Title
Assess the compliance of ICU staff with implementing VAP prevention bundel as an EBP
Description
VAPPCC is an advanced tool formulated by researchers in terms of the proposed VAP prevention EBP (ten bundle). VAPPCC consists of ten items, including the satisfactory criteria for each item. The ICU staff's compliance for each item ranged from 1 (yes) to 0 (no), with a minimum score of 0 and a maximum of 10. The charge nurse will use VAPPCC to assess the provided care for MV patients daily.
Time Frame
35-40 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ICU patients intubated mechanical ventilation for more than 48 hours Also, the ICU staff (medical or nurses) working in the selected ICU will be invited to participate in this study to learn and implement the ten VAP preventive bundles. Exclusion Criteria: Patients intubated outside the IFH. patients have immunocompromised diseases will be excluded.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11612
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Selected Evidence-based Practices and Related Nurses' Education on the Incidence and Severity of Ventilator-associated Pneumonia

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