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Methods of Chlorhexidine Cleansing to Prevent Ventilator-Associated Pneumonia (VAP)

NCT02077920 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2019-08-14

No results posted yet for this study

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.

Conditions

  • Ventilator-associated Pneumonia

Interventions

DRUG

Chlorhexidine

SFDA Approval No. H21020748; Jinzhou Jiu Tai Pharmaceutical Co., Ltd., Liaoning, China Drug administration and preparation: * Drug administration: oropharyngeal rinsing and suctioning of subglottic secretions * Drug preparation: 0.12% chlorhexidine solution prepared with distilled water that has been sterilized by autoclaving

DRUG

0.9% sodium chloride injection

SFDA Approval No. H20045252; Shenyang Zhiying Pharmaceutical Co., Ltd., Liaoning, China

DEVICE

Endotracheal tube

Type 5-10115; size 7.0 mm, 7.5 mm, or 8.0 mm; purchased from Teleflex Medical (USA).

DEVICE

Fiber bronchoscope

For suctioning of subglottic secretions. BF-P30 (Olympus, Japan); BF-1T20 (Olympus, Japan); or FB-18BS (Pentax, Japan).

Sponsors & Collaborators

  • General Hospital of Shenyang Military Region

    lead OTHER

Principal Investigators

  • Zhuang Ma, Ph.D. · The General Hospital of Shenyang Military Region

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2019-06-30
Completion
2019-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02077920 on ClinicalTrials.gov