Skip to main content
OpenTrials
Completed

NCT Number: NCT03382730

De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle (CHORAL)

The objective of the CHORAL study is to evaluate the de-adoption of oral chlorhexidine and the introduction of a bundle of oral care practices on selected outcomes in critically ill mechanically ventilated adults.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mortality Dryness, Mouth Facial Pain Mouth Diseases Neurologic Manifestations Oral Health Pain Pain, Orofacial Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Signs and Symptoms Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

Loading trial locations.

About this study

Infrequent or ineffective oral care can lead to mouth discomfort and lung infection for patients treated with ventilators (breathing machines) in intensive care units (ICUs). A commonly used mouthwash called chlorhexidine can reduce lung infection but most recent evidence shows it may increase the risk of death. In this study 6 participating intensive care units (ICUs) will de-adopt oral chlorhexidine and introduce a bundle of oral care practices using a multi-faceted educational tool kit. The investigators will measure changes in patient-oriented outcomes including mortality, ventilator-associated complications (VACs) and oral health status. A concurrent process evaluation will study how the intervention is delivered and received by patients and clinicians..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who receive mechanical ventilation in the participating ICUs.

Exclusion criteria

  • Does not meet inclusion criteria.

Treatment and study plan

Chlorhexidine Mouth Rinse

Other

Oral chlorhexidine gluconate oral rinse

Other names: Chlorhexidine

Chlorhexidine Mouth Rinse De-Adoption

Other

Multifaceted education and audit/feedback.

Other names: De-adopt chlorhexidine

Primary outcomes

  1. Intensive Care Unit (ICU) Mortality

    Time frame: 14 months

    All-cause mortality at time of ICU discharge

Secondary outcomes

  1. Infection-related ventilator-associated complications (IVACs)

    Time frame: 14 months

    Changes in IVACs rates between groups

  2. Beck Oral Assessment Score (BOAS), Modified

    Time frame: 14 months

    Changes in oral health between groups. Scores range from 5 (normal) to 20 (severe dysfunction).

  3. Critical Care Pain Observational Tool (CPOT)

    Time frame: 14 months

    Changes in oropharyngeal pain between groups. CPOT scores range from 0-8 with a score >2 indicating presence of pain.

  4. Oral Dryness - Numeric Rating Intensity Scale (NRS)

    Time frame: 14 months

    Changes in oral dryness scores between groups. NRS scores range from 0 (no dryness) to 10 (severe dryness).

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • MOUNT SINAI HOSPITAL
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital
  • Unity Health Toronto
  • University Health Network, Toronto

Registry information

Official study title

A Multi-centered Stepped Wedge Cluster Randomized Controlled Trial of the De-adoption of Oral Chlorhexidine Prophylaxis and Implementation of an Oral Care Bundle for Ventilated Critically Ill Patients

Acronym: CHORAL

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 26, 2017
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.