Atropine for Preventing Ventilator-Associated Pneumonia

Universidade de Passo Fundo

Status and phase: Completed; Phase 2

Conditions: Ventilator-Associated Pneumonia

Treatments: Drug: Placebo; Drug: Atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT02704923

CAAE 40374815.3.0000.5342

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Atropine

Active Comparator group

Treatment:

Drug: Atropine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo