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Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04252469
Enrollment
210
Registered
2020-02-05
Start date
2019-05-01
Completion date
2019-08-31
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Intratracheal Intubation, Surgery

Keywords

oral care, Anesthesia, surgery, Intratracheal Intubation

Brief summary

This single-centre, single-blind, randomised controlled study with parallel-group design was conducted in Yun Ling, Taiwan between May 2019 and August 2019. Participants were randomly allocated to an intervention (mouth care using 0.12% CHX before intubation) or control (standard care) group on a 1:1 basis. This study was approved by the institutional review board of National Taiwan University Hospital, Taiwan (IRB No.201806086RINB). Each participant completed written informed consent after explanation of this study and advised that they could withdraw anytime.

Detailed description

Participants were recruited at the operation room of a teaching hospital. Participants were included if they met the following criteria: 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia. Patients were excluded if they were diagnosed with upper or lower respiratory tract disease, including COPD, cold, had oral ulcer, scheduled to have a respiratory-related surgical procedure, had endotracheal tube intubated.

Interventions

oral care using 20mL of 0.12% CHX and gargling with 30 seconds.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia.

Exclusion criteria

* Patients were excluded if they were diagnosed with upper or lower respiratory tract disease, including COPD, cold, had oral ulcer, scheduled to have a respiratory-related surgical procedure, had endotracheal tube intubated, \>1 during anesthesia processes,

Design outcomes

Primary

MeasureTime frameDescription
Bacterial Colonization (Gram stain)at baseline (30 minutes before surgery started)Bacterial Colonization

Secondary

MeasureTime frameDescription
Breathing odor assessment using questionnaireat baseline (30 minutes before surgery started)Breathing odor assessment
Breathing odor assessment using halitosis detectorat baseline (30 minutes before surgery started)Breathing odor assessment

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026