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

NCT04165356 | Unknown

• 1 other identifier: 2019-013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chlorhexidine mouthwashes; chlorhexidine efficacy; artificial respiration; cross infection; ventilator-associated pneumonia

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of Infections Associated with Mechanical Ventilation.

  New cases of respiratory infections (except pneumonia) developed in susceptible individuals entering the study, during the period of the study.

  Developed during the period of permanence of endotracheal intubation procedure and up to 48 hours after its withdrawal

• Cumulative incidence of Pneumonia Associated with Mechanical Ventilation

  New cases of pneumonia associated with mechanical ventilation developed in susceptible individuals entering the study, during the period of the study.

  Developed during the period of permanence of endotracheal intubation procedure and up to 48 hours after withdrawal

Study Arms (2)

Mouth-rinse with clorhexidine

EXPERIMENTAL

Mouth-rinse with 0.12% clorhexidine + tooth brushing twice daily

Procedure: Mouth-rinse with 0.12% clorhexidine

Mouth-rinse with bicarbonate isotonic solution

ACTIVE COMPARATOR

Mouth-rinse with isotonic solution with 1.5% sodium bicarbonate + tooth brushing twice daily

Procedure: Mouth-rinse with isotonic solution with 1.5% sodium bicarbonate

Interventions

Mouth-rinse with 0.12% clorhexidine PROCEDURE

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.

Mouth-rinse with clorhexidine

Mouth-rinse with isotonic solution with 1.5% sodium bicarbonate PROCEDURE

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

Mouth-rinse with bicarbonate isotonic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients admitted to the ICU will be included, with less than 24 hours of endotracheal intubation due to mechanical ventilation requirements, whose responsible family member gives informed consent.

You may not qualify if:

• Patients with known hypersensitivity or contraindications for the use of oral chlorhexidine, patients with a diagnosis of admission to the ICU of any respiratory tract infection, toothless patients and pregnant patients.

Sponsors & Collaborators

• Universidad Autónoma de Yucatán: lead
• Hospital Regional de Alta Especialidad de la Península de Yucatán: collaborator

Study Sites (1)

Hospital Regional de Alta Especialidad de La Peninsula de Yucatan

Mérida, Yucatán, 97133, Mexico

RECRUITING

MeSH Terms

Conditions

Cross Infection; Pneumonia, Ventilator-Associated

Interventions

Mouthwashes; Isotonic Solutions; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Solutions; Pharmaceutical Preparations; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ligia Rosado Alcocer, MPH

  Facultad de Enfermería, Universidad Autónoma de Yucatán

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Salcedo, Dr

CONTACT

+521-777-135-3755; alejandra.salcedo@correo.uady.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: All mouth-rinse bottles will have the same external appearance, being plastic bottles with integrated spray atomizer and protective plastic cap. Each bottle will have a unique folio for identification printed on the identification label. The clinical staff working in the Hospital and having contact with the study subjects will be blinded at all times to the care group assigned to the patient. Academic staff working outside the Hospital and will not have direct contact with the study subjects, will not be blinded to the assigned group, in order to administer a second bottle of treatment if necessary.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomly asignated to one of two parallel groups of mouth-rinse treatments: 1. Mouth-rinse with 0.12% clorhexidine + tooth brushing twice daily 2. Mouth-rinse with isotonic solution with 1.5% sodium bicarbonate + tooth brushing twice daily

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: November 11, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)