Oral Care Layered Enhancement for Improved Oral Hygiene in Intensive Care Units

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital do Coracao

About this trial

The goal of the ORACLE study is to evaluate the impact of implementing a standardized oral hygiene bundle on outcomes in critically ill, mechanically ventilated patients. The primary objective is to determine whether this bundle can increase the number of ventilator-free days compared to the standard of care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients who receive mechanical ventilation in the participating intensive care units

Disqualifiers

Does not meet inclusion criteria

Trial design

Design model

Sequential

Treatments tested in this trial

  • Oral hygiene bundle

    Other intervention

    Implementation of the standardized oral hygiene bundle, which consists of the following key components: Standardization of materials used during the oral hygiene procedure, standardization of oral hygiene frequency, training of nursing staff involved in patient care on proper oral hygiene practices, discontinuation of routine application of chlorhexidine oral solution, and implementation of a standardized oral hygiene technique.

Treatment groups

4,800 Participants
are divided into 2 treatment groups
Group A: Oral hygiene bundleExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ventilator free days

Days alive and free from mechanical ventilation

Time frame
28 days after enrollment

Secondary outcomes

1

Intensive Care Unit all cause mortality

All cause mortality during intensive care unit stay

Time frame
15 months
2

Hospital all cause mortality

All cause mortality during hospital stay

Time frame
15 months
3

Ventilator associated pneumonia incidence

Defined as the number of ventilator associated pneumonia cases adjusted per ventilated-patients/days

Time frame
15 months
4

Intensive care unit free days

Days alive and free from intensive care unit

Time frame
28 days after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital do Coracao

Lead sponsor

Faculdade de Medicina de Ribeirão Preto/USP

Collaborator

This trial is not recruiting at the moment. You can still explore other options: