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Trial record 15 of 225 for:    "Pneumonia, Ventilator-Associated"

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

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ClinicalTrials.gov Identifier: NCT02077920
Recruitment Status : Unknown
Verified February 2016 by Zhuang Ma, General Hospital of Shenyang Military Region.
Recruitment status was:  Recruiting
First Posted : March 4, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Zhuang Ma, General Hospital of Shenyang Military Region

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.


Condition or disease Intervention/treatment Phase
Ventilator-associated Pneumonia Drug: Chlorhexidine Drug: 0.9% sodium chloride injection Device: Endotracheal tube Device: Fiber bronchoscope Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Ventilator-Associated Pneumonia by Oropharyngeal and Subglottic Decontamination Via Bronchoscopy
Study Start Date : March 2014
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Chlorhexidine before intubation
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

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

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

Experimental: Chlorhexidine after intubation
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

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

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

Experimental: Subglottic secretion drainage

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

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

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

Experimental: 0.9% sodium chloride injection
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
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).




Primary Outcome Measures :
  1. The incidence of Ventilator-associated Pneumonia [ Time Frame: an expected average of 30 days ]
    Percentage of patients who develop VAP after endotracheal intubation


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Until discharge from hospital, an expected average of 30 days ]
    Number of days of hospitalization

  2. Length of intensive care unit stay [ Time Frame: an expected average of 30 days ]
    Number of days in the intensive care unit

  3. Duration of mechanical ventilation [ Time Frame: Until the last day of mouthpiece ventilation, an expected average of 30 days ]
    Influence of interventions on the duration of mechanical ventilation.

  4. Hospital costs [ Time Frame: During entire hospitalization, an expected average of 30 days ]
    Total costs incurred during hospitalization.

  5. 30-day mortality [ Time Frame: An expected average of 30 days ]
    Percentage of patients who die.


Other Outcome Measures:
  1. Vital signs [ Time Frame: Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation ]
    Temperature, heart rate, blood pressure, level of consciousness

  2. Laboratory tests [ Time Frame: Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation ]
    White blood cell count, platelet count, throat swab culture, sputum culture, routine urinalysis, midstream urine culture, liver and kidney function tests, serum biochemistry tests, C-reactive protein level, procalcitonin level, brain natriuretic peptide level, subglottic secretion culture.

  3. Arterial blood gas analysis [ Time Frame: Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation ]
    pH, PO2 (mmHg), PCO2 (mmHg), lactate level (mmol/L), PO2/FiO2.

  4. Other investigations [ Time Frame: Before intubation, and 48 hours, 4 days, 7 days, 14 days, and 30 days after intubation ]
    Electrocardiography, echocardiography, chest X-ray.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077920


Contacts
Contact: Zhuang Ma, M.D., Ph.D. +862428897551 ma-tianyi@163.com

Locations
China, Liaoning
The General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China, 110000
Contact: Zhuang Ma         
Principal Investigator: Zhuang Ma, PhD         
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Principal Investigator: Zhuang Ma, Ph.D. The General Hospital of Shenyang Military Region

Responsible Party: Zhuang Ma, Professor, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT02077920     History of Changes
Other Study ID Numbers: GHS-RCU-001
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhuang Ma, General Hospital of Shenyang Military Region:
Ventilator-associated pneumonia VAP
Chlorhexidine
Oropharyngeal decontamination
Subglottic secretion drainage

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents