Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Conditions
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Intratracheal Intubation, Surgery, Anesthesia

Intervention / Treatment
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* Other: Oral care


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds. | Other: Oral care<br>* oral care using 20mL of 0.12% CHX and gargling with 30 seconds.<br>|
| No Intervention: Control<br>Standardized care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial Colonization (Gram stain) | Bacterial Colonization | at baseline (30 minutes before surgery started) | 
| Bacterial Colonization (Gram stain) | Bacterial Colonization | at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube ) | 
| Bacterial Colonization (Gram stain) | Bacterial Colonization | after removal of endotracheal tube at recovery room (15 minutes after surgery ended) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathing odor assessment using questionnaire | Breathing odor assessment | at baseline (30 minutes before surgery started) | 
| Breathing odor assessment using questionnaire | Breathing odor assessment | at insertion of endotracheal tube | 
| Breathing odor assessment using questionnaire | Breathing odor assessment | after removal of endotracheal tube and at recovery room (15 minutes after surgery ended) | 
| Breathing odor assessment using halitosis detector | Breathing odor assessment | at baseline (30 minutes before surgery started) | 
| Breathing odor assessment using halitosis detector | Breathing odor assessment | after removal of endotracheal tube and at recovery room (15 minutes after surgery ended) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral care, Anesthesia, surgery, Intratracheal Intubation