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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR007652 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-intubation CHX | Experimental | Chlorhexidine applied to oral cavity prior to intubation |
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| Control | Active Comparator | No chlorhexidine applied to oral cavity prior to intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-intubation CHX | Procedure | 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy L Munro, RN,ANP,PHD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298-0567 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25317722 | Result | Munro CL, Grap MJ, Sessler CN, Elswick RK Jr, Mangar D, Karlnoski-Everall R, Cairns P. Preintubation application of oral chlorhexidine does not provide additional benefit in prevention of early-onset ventilator-associated pneumonia. Chest. 2015 Feb;147(2):328-334. doi: 10.1378/chest.14-0692. |
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Subjects were enrolled from two large urban teaching medical centers (VCU Health System, Tampa General Hospital). Subjects were recruited in multiple clinical areas just prior to intubation, including critical care units, emergency departments, pre-operative areas, procedural areas, and medical-surgical units during rapid response or code calls.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Preintubation Oral Chlorhexidine | Intervention: 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. |
| FG001 | 2: Control | Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adults requiring endotracheal intubation
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Preintubation Oral Chlorhexidine | Intervention: 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. |
| BG001 | 2: Control |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Subjects who had complete CPIS data on admission to the study (Day 0) and subsequent complete CPIS data from day 2, 3, 4 or 5 (47 CHX & 47 control, 438 observations) were included in the analysis in accordance with intent to treat analysis principles. | Posted | Mean | Standard Error | units on a scale | Baseline up to 5 days |
|
10 days
Medical record review Medical provider report
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1: Intervention | Intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cindy L. Munro, APRN, PhD | University of South Florida | 813-974-7597 | cmunro2@health.usf.edu |
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| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D053717 | Pneumonia, Ventilator-Associated |
| D007239 | Infections |
| ID | Term |
|---|---|
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Control | Procedure | No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation |
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| 5 days |
| Serum Procalcitonin | 5 days |
Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 2: COntrol | Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation |
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|
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| Secondary | 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. | The subjects analyzed were a subset of subjects enrolled in the study from whom endotracheal tunes were obtainable for microbial culture post-intubation. Subset analysis was planned a priori. | Posted | Number | percentage of ET tubes colonized | 24 hours |
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|
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| Secondary | Serum Cytokines | Not Posted | 5 days |
| Secondary | Serum Procalcitonin | Not Posted | 5 days |
| 0 |
| 157 |
| 0 |
| 157 |
| EG001 | 2: Control | Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation | 0 | 157 | 0 | 157 |
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| D000077299 | Healthcare-Associated Pneumonia |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |