Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877105
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2023-05-17
Brief Title:
Effect of Selected Evidence-based Practices and Related Nurses Education on the Incidence and Severity of Ventilator-associated Pneumonia
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Selected Evidence-based Practices and Related Nurses Education on the Incidence and Severity of Ventilator-associated Pneumonia
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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 researchs 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
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 eg 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 researchs 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 eg 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 researchs 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 V3194 Psychonomic Society Madison Wisconsin USA with α 005 power 1-β err prob 080 and effect size 06 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
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 eg 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 researchs 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 V3194 Psychonomic Society Madison Wisconsin USA with α 005 power 1-β err prob 080 and effect size 06 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None