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

NCT02077920 | Completed Phase 2 DMC

• 1 other identifier: GHS-RCU-001
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ventilator-associated pneumonia VAP; Chlorhexidine; Oropharyngeal decontamination; Subglottic secretion drainage

Outcome Measures

Primary Outcomes (1)

• The incidence of Ventilator-associated Pneumonia

  Percentage of patients who develop VAP after endotracheal intubation

  an expected average of 30 days

Secondary Outcomes (5)

• Length of stay

  Until discharge from hospital, an expected average of 30 days

• Length of intensive care unit stay

  an expected average of 30 days

• Duration of mechanical ventilation

  Until the last day of mouthpiece ventilation, an expected average of 30 days

• Hospital costs

  During entire hospitalization, an expected average of 30 days

• 30-day mortality

  An expected average of 30 days

Other Outcomes (4)

• Vital signs

  Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation

• Laboratory tests

  Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation

• Arterial blood gas analysis

  Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation

Study Arms (4)

Chlorhexidine before intubation

EXPERIMENTAL

Group A: Oropharyngeal decontamination with chlorhexidine before intubation, n=48. Oral cleansing with chlorhexidine will be performed before endotracheal intubation, and every 6 hours after intubation.

Drug: Chlorhexidine; Device: Endotracheal tube

Chlorhexidine after intubation

EXPERIMENTAL

Group B: Oropharyngeal decontamination with chlorhexidine after intubation, n=48. Oral cleansing with chlorhexidine will be performed every 6 hours after endotracheal intubation.

Drug: Chlorhexidine; Device: Endotracheal tube

Subglottic secretion drainage

EXPERIMENTAL

Group C: Suctioning of subglottic secretions, n=48. Oral cleansing with chlorhexidine will be performed before endotracheal intubation and every 6 hours after intubation, and fiberoptic bronchoscopy-guided suctioning of subglottic secretions will be performed at 10:00 a.m. every day. The procedure will be as follows: 1. Routine cleaning of the bronchoscope. 2. Oral or nasal insertion of the bronchoscope (according to the decision of the attending physician based on the patient's condition). Rinsing of the subglottic region with 5-20 mL of chlorhexidine solution followed by suctioning. The rinsing procedure will be repeated 3-5 times. 3. Routine cleaning of the bronchoscope. The patient will be monitored during all procedures.

Drug: Chlorhexidine; Device: Fiber bronchoscope

0.9% sodium chloride injection

EXPERIMENTAL

Group D: 0.9% sodium chloride injection, n=48. After endotracheal intubation, oral cleansing with normal saline will be performed every 6 hours.

Drug: 0.9% sodium chloride injection; Device: Endotracheal tube

Interventions

Chlorhexidine DRUG

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

Chlorhexidine after intubation; Chlorhexidine before intubation; Subglottic secretion drainage

0.9% sodium chloride injection DRUG

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

0.9% sodium chloride injection

Endotracheal tube DEVICE

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

0.9% sodium chloride injection; Chlorhexidine after intubation; Chlorhexidine before intubation

Fiber bronchoscope DEVICE

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

Subglottic secretion drainage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients who are scheduled for endotracheal intubation and mechanical ventilation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

The General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Chlorhexidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhuang Ma, Ph.D.

  The General Hospital of Shenyang Military Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: March 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)