Efficacy of Mouth-rinse With Chlorhexidine for the Prevention of Ventilator-associated Infections in Intensive Care Unit

Summary

Background:

Infections associated with mechanical ventilation are associated with high rates of morbidity and mortality, which results not only in an increase in hospitalization days and care costs, but also in an increase in DALYS (years of life disability adjustment) in the population.

Critically ill patients have a high risk of infection as a result of underlying immunodeficiency, comorbidity and placement of invasive devices (such as endotracheal tubes and intravascular devices). Infections in these patients constitute a challenge for hospital authorities, as they are considered a social and economic problem that influences the quality of care, in a system where health services are increasingly affected by high patient care costs and the reduction of public spending.

The decrease in the number of bacteria in the oral cavity reduces the presence of microorganisms available for translocation and colonization of the lower respiratory tract; Therefore, performing oral care intervention is considered an economically attractive method to reduce the risk of developing infections associated with endotracheal intubation.

In our environment, oral cleaning is performed as part of the nursing care package granted to all patients of the ICU, however, there is no standardized method among nursing staff that guarantees the desired prevention.

Objective: To evaluate the efficacy and safety of mouth-rinse with 0.12% chlorhexidine to prevent infections associated with mechanical ventilation in patients in the intensive care unit in a third level hospital in Mérida, Yucatán.

Hypothesis: Mouth-rinse with 0.12% chlorhexidine twice daily more effective and safe than mouthwash with bicarbonated isotonic solution twice daily to prevent infections associated with mechanical ventilation in patients in the intensive care unit of a hospital third level.

Methodology: Double-blind randomized controlled clinical trial with active substance for the evaluation of the non-inferiority of the efficacy and safety of mouthwash with 0.12% chlorhexidine twice daily compared to isotonic bicarbonated solution twice daily for the prevention of any infection associated with mechanical ventilation in patients requiring endotracheal intubation in the intensive care unit of a third level hospital.

Conditions

• Infections Associated With Mechanical Ventilation
• Pneumonia Associated With Mechanical Ventilation

Interventions

PROCEDURE

Mouth-rinse with 0.12% clorhexidine

mouthwash with 0.12% chlorhexidine twice daily compared to isotonic bicarbonated solution twice daily for the prevention of any infection associated with mechanical ventilation in patients requiring endotracheal intubation in the intensive care unit of a third level hospital.

PROCEDURE

Mouth-rinse with isotonic solution with 1.5% sodium bicarbonate

mouthwash with sotonic solution with 1.5% sodium bicarbonate twice daily for the prevention of any intection associated with mechanical ventilation

Sponsors & Collaborators

• Hospital Regional de Alta Especialidad de la Península de Yucatán

  collaborator OTHER

• Universidad Autónoma de Yucatán

  lead OTHER

Principal Investigators

• Ligia Rosado Alcocer, MPH · Facultad de Enfermería, Universidad Autónoma de Yucatán

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-11

Primary Completion

2020-02-29

Completion

2020-03-31

Countries

• Mexico

Study Locations