Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Not Applicable

Completed

• Conditions: Surgery; Anesthesia; Intratracheal Intubation
• Interventions: Other: Oral care

• Registration Number: NCT04252469
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-01
• Study First Submitted: 2020-01-16
• Study First Submitted QC: 2020-01-31
• Last Update Submitted: 2020-01-31
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Oral care	receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds.

Primary Outcome Measures

Name	Time	Method
Bacterial Colonization (Gram stain)	after removal of endotracheal tube at recovery room (15 minutes after surgery ended)	Bacterial Colonization

Secondary Outcome Measures

Name	Time	Method
Breathing odor assessment using questionnaire	after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)	Breathing odor assessment
Breathing odor assessment using halitosis detector	after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)	Breathing odor assessment

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan