NCT05877105

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

Completed NA Last updated 9 January 2024

What this trial tests

NA trial testing Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle in Evidence-based Practices in 99 participants. Completed in 30 November 2023.

Timeline

17 May 2023

Primary endpoint
30 November 2023

30 November 2023

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	99
Start date	17 May 2023
Primary completion	30 November 2023
Estimated completion	30 November 2023
Sites	1 location across Egypt

Drugs / interventions tested

• Ventilator-associated pneumonia prevention Evidence-based practices (VAPPEBP) which consists of ten items bundle

Conditions studied

• Evidence-based Practices — all drugs for Evidence-based Practices →
• Nursing Education — all drugs for Nursing Education →
• Incidence — all drugs for Incidence →
• Ventilator-associated Pneumonia — all drugs for Ventilator-associated Pneumonia →

Sponsor

Cairo University

Who can join

20 and older, any sex, with Evidence-based Practices or Nursing Education. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.