Methods of Chlorhexidine Cleansing to Prevent Ventilator-Associated Pneumonia (VAP)
Information source: General Hospital of Shenyang Military Region
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ventilator-associated Pneumonia
Intervention: Chlorhexidine (Drug); 0.9% sodium chloride injection (Drug); Endotracheal tube (Device); Fiber bronchoscope (Device)
Phase: Phase 2
Status: Recruiting
Sponsored by: General Hospital of Shenyang Military Region Official(s) and/or principal investigator(s): Zhuang Ma, Ph.D., Principal Investigator, Affiliation: The General Hospital of Shenyang Military Region
Overall contact: Zhuang Ma, M.D., Ph.D., Phone: +862428897551, Email: ma-tianyi@163.com
Summary
Ventilator-associated pneumonia (VAP) is common in patients receiving mechanical
ventilation, and is associated with longer hospital stay, increased treatment costs, and
higher rates of morbidity and mortality . VAP is reported to occur in 8%-67% of mechanically
ventilated patients (20%-28% in most reports) and has a mortality rate of 24%-50%, which is
2-3 times the mortality rate of mechanically ventilated patients without VAP. In patients
infected by multi-resistant bacteria, the mortality rate may be as high as 76%. The
diagnosis, treatment, and prevention of VAP are therefore important. Strategies for
preventing VAP are crucial for reducing medical costs and increasing survival rates in
critically ill patients. These strategies mainly involve a semi-reclining position with the
head of the bed raised to at least 30°-45°, oral care, suctioning of subglottic secretions,
selective decontamination of the digestive tract, proper hand washing, avoidance or
reduction of proton pump inhibitors, avoidance of excessive sedation, and control of plasma
glucose levels.
At our center, VAP is mainly caused by bacterial colonization of the upper respiratory tract
via aspiration. This study will compare four interventions including oropharyngeal
decontamination and subglottic suctioning by bronchoscopy, with the aim of developing a
prevention strategy to minimize the development of VAP during mechanical ventilation.
Clinical Details
Official title: Prevention of Ventilator-Associated Pneumonia by Oropharyngeal and Subglottic Decontamination Via Bronchoscopy
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: The incidence of Ventilator-associated Pneumonia
Secondary outcome: Length of stayLength of intensive care unit stay Duration of mechanical ventilation Hospital costs 30-day mortality
Detailed description:
Patients will be assessed as follows:
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DDBCA ADCAD DABCD CBAAB DDDCD AABAB ACBCD BCCBA ADCDB CBCAB CDDCA CDDDD ABCDA ABDCB CBADD
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Adverse Events:
Adverse events that occur after endotracheal intubation, mechanical ventilation, oral
cleansing with chlorhexidine, and suctioning of oropharyngeal secretions by bronchoscopy
will be recorded. All adverse events including laboratory abnormalities will be recorded,
even if they are thought to be unrelated to medical interventions. The severity of adverse
events and any correlations with experimental drugs will be carefully recorded on the case
report form.
The relationships between adverse events and drug resistance will be categorized as
certainly relevant, probably relevant, possibly relevant, possibly irrelevant, or certainly
irrelevant. The proportions of adverse events that are categorized as certainly relevant,
probably relevant, and possibly relevant will be calculated. Severe adverse events will be
recorded in a table and reported to the director of the unit and the sponsor within 24
hours.
Severity Assessment:
The severity of adverse events will be categorized as mild, moderate, or severe. A mild
adverse event is defined as an event with signs and symptoms that are easy to tolerate such
as nausea, vomiting, or transient localized pain. A moderate adverse event is defined as an
event resulting in persistent pain. A severe adverse event is defined as an event resulting
in prolonged hospitalization, disability, reduced ability to work, risk of death, or
congenital malformation.
The outcomes of all adverse events will be recorded. Patients who withdraw from the trial
because of adverse events will be followed up until complete resolution of the events. The
investigators will judge whether the adverse events are related to the administration of
experimental drugs, and will record the justification for each decision.
Data Management:
Completed case report forms will be collected by the clinical coordinator and the data will
be entered into the database. After checking for accuracy, the data will be locked. After
unblinding, the data will be categorized according to the four groups of patients.
Statistical Analysis:
Numerical data will be described as percentages, and measurement data as mean ± standard
deviation. Abnormally distributed data will be described as median and interquartile range
(25th-75th percentile).
Comparisons of Baseline Data:
Numerical data will be compared between groups using the chi-square test or Fisher's exact
test. Measurement data with normal distributions will be analyzed by single- or multi-factor
analysis of variance. Data with high heterogeneity will be compared using a non-parametric
test such as Tamhane's T2 test. Measurement data with non-normal distributions will be
compared using the non-parametric Mann-Whitney U test or the Kruskal-Wallis rank sum test.
Groups will be compared at baseline and at different time points after enrollment.
Comparisons of Efficacy:
Analgesic and sedative effects will be compared among groups using the Kruskal-Wallis rank
sum test. For factors showing significant differences among groups, pairwise comparisons
will be analyzed using the non-parametric Mann-Whitney U test. Mean values will be compared
between groups using the Cochran-Mantel-Haenszel chi-square test.
Data Processing:
All statistical analyses will be performed using SAS software. Two-sided P values will be
calculated. For Fisher's exact test, the P value will be calculated directly. A value of P
<0. 05 is considered significant, and P <0. 01 is considered highly significant.
Quality Assurance:
This study will have one principal investigator, one research investigator, and four other
investigators. The clinical protocol will be strictly implemented. An independent inspector
will be appointed to monitor the clinical trial.
Quality Control of the Parameters Measured:
The parameters recorded will be measured according to standard operating and quality control
procedures, using standard national units of measurement. Test report forms will be fully
completed including the date, parameters tested, test results, and normal ranges.
Ethical Standards:
The investigators or investigator-authorized personnel will explain the benefits and risks
of participating in the clinical trial to each patient, or to the patient's legal
representative. Written informed consent will be obtained prior to study entry (before
performance of tests and administration of drugs). The original consent forms will be stored
by the investigators.
Data Retention:
The investigators will be responsible for maintaining the database and keeping the data
locked for future analysis. In accordance with the principles of good clinical practice in
China, the data will be kept for at least 5 years.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who are scheduled for endotracheal intubation and mechanical ventilation.
Exclusion Criteria:
- Patients who underwent endotracheal intubation or tracheotomy before study
enrollment.
- Patients who underwent endotracheal intubation and mechanical ventilation within 30
days before study enrollment.
- Patients who require cardiopulmonary resuscitation.
- Patients with a history of emesis and aspiration before endotracheal intubation.
- Patients who are judged unsuitable for enrollment by clinicians.
Locations and Contacts
Zhuang Ma, M.D., Ph.D., Phone: +862428897551, Email: ma-tianyi@163.com
The General Hospital of Shenyang Military Region, Shenyang, Liaoning 110000, China; Recruiting Zhuang Ma Zhuang Ma, PhD, Principal Investigator
Additional Information
Starting date: March 2014
Last updated: March 12, 2015
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