Ventilator-Associated Pneumonia
Conditions
Keywords
Atropine, Pneumonia, Ventilator, Adults, Intensive care unit.
Brief summary
A double-blind, placebo controlled trial of atropine eye drops used by sublingual way for preventing Ventilator-Associated Pneumonia.
Detailed description
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.
Interventions
DRUGAtropine
Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
DRUGPlacebo
Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours
Sponsors
Universidade de Passo Fundo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator-Associated Pneumonia | through the end of the study, an average of one year | Incidence of ventilator-associated pneumonia through the end of the study, an average of one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | through the end of the study, an average of one year | Incidence of death through the end of the study, an average of one year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | through the end of the study, an average of one year | Incidence of adverse events through the end of the study, an average of one year |
Outcome results
None listed