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A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atropine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine | Drug | Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence of adverse events through the end of the study, an average of one year | through the end of the study, an average of one year |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo | Drug | Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours |
|
|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |