Strategies To Prevent Pneumonia 2 (SToPP2)

Study Overview
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Brief Summary
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Ventilator-associated pneumonia (VAP) is a serious complication in mechanically ventilated critically ill patients. The intervention tested in this project (swabbing the mouth with chlorhexidine before the endotracheal tube is inserted) could reduce the risk of ventilator-associated pneumonia.

Detailed Description
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Ventilator-associated pneumonia (VAP) is an acute care complication with high morbidity and mortality, which is costly in length of stay and resources used. Application of chlorhexidine (CHX) to the mouths of critically ill adults after intubation reduces risk of VAP. During intubation, organisms may be dragged by the tube from the contaminated mouth to the sterile lung, and the endotracheal tube (ET) provides a pathway for direct entry of bacteria from the mouth to the lower respiratory tract. However, procedures to decontaminate the mouth before intubation are not routine and little is known about the effects of pre-intubation CHX in critically ill patients. Thus, this project focuses on evaluating the benefit of adding a pre-intubation CHX dose to the known benefit of post-intubation CHX to reduce the risk of VAP. In order to examine the effect of pre-intubation CHX on early ET colonization, we will perform microbial cultures of ETs of subjects who are extubated in the first 24 hours of study participation. We will also explore selected biomarkers (procalcitonin, cytokines) as indicators of development of VAP in a subset of subjects. The project will add to knowledge about the relationships among oral health, ET intubation and VAP, and addresses an important clinical outcome. Pre-intubation oral decontamination could reduce risk of VAP and its associated morbidity and mortality.

Official Title
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Oral Care Intervention in Mechanically Ventilated Adults

Conditions
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Infections, Hospital, Ventilator-Associated Pneumonia, Mechanical Ventilation Complication

Intervention / Treatment
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* Procedure: Pre-intubation CHX
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Need for intubation Exclusion Criteria: Pneumonia at the time of intubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-intubation CHX<br>Chlorhexidine applied to oral cavity prior to intubation | Procedure: Pre-intubation CHX<br>* Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.<br>|
| Active Comparator: Control<br>No chlorhexidine applied to oral cavity prior to intubation | Procedure: Control<br>* No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of VAP (Clinical Pulmonary Infection Score) | Change between post-intervention CPIS and baseline CPIS. Serial prospective evaluation of VAP risk. 6 elements of CPIS (tracheal secretions, temperature, white blood count, oxygenation, chest radiograph, and tracheal aspirate culture) summed to yield total score of 0-12 daily; higher score reflects greater likelihood of VAP. | Baseline up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal Tube Colonization | semiquantitative swab culture for potentially pathogenic organisms of distal end of the endotracheal tube (ETT) interior lumen at extubation. Results were collapsed into two categories: colonization (moderate or many organisms) or no colonization. | 24 hours | 
| Serum Cytokines |  | 5 days | 
| Serum Procalcitonin |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nosocomial (Hospital-Acquired) Infections, Ventilator-Associated Pneumonia, Mechanical ventilation, Endotracheal intubation