Atropine for Preventing Ventilator-Associated Pneumonia

Study Overview
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Brief Summary
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A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.

Detailed Description
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A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia was conducted in Passo Fundo - RS, south Brazil. 40 adult patients were included (exploratory stage 2 trial). Interventions were initiated until 48 hours of patients were submitted to orotracheal intubation: 2 drops of atropine (eye drop) by sublingual way, compared to placebo on the same regimen. Efficacy outcomes were pneumonia and death, but safety was also assessed. No difference was observed between the placebo and atropine groups in terms of efficacy and safety outcomes. The small sample and a significance difference in terms of initiating the interventions (medians: 48h for atropine; 24h for placebo) may be a conservative bias. This can not exclude a possible benefit of atropine that should be better evaluated in a stage 3 trial.

Official Title
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Atropine for Preventing Ventilator-Associated Pneumonia

Conditions
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Ventilator-Associated Pneumonia

Intervention / Treatment
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* Drug: Atropine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient admitted in intensive care unit with endotracheal intubation and ventilator initiated until 48 hours Exclusion Criteria: Pneumonia, radiotherapy, chemiotherapy, conditions that interfere with saliva production or change normal oral cavity shape

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atropine<br> | Drug: Atropine<br>* Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours<br>* Other names: Atropine eye drops;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours<br>* Other names: Placebo eye drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-Associated Pneumonia | Incidence of ventilator-associated pneumonia through the end of the study, an average of one year | through the end of the study, an average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Incidence of death through the end of the study, an average of one year | through the end of the study, an average of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atropine, Pneumonia, Ventilator, Adults, Intensive care unit.