Skip to main content
OpenTrials
Completed

NCT Number: NCT04252469

Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intratracheal Intubation Anesthesia Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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,

Treatment and study plan

Oral care

Other

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

Primary outcomes

  1. Bacterial Colonization (Gram stain)

    Time frame: at baseline (30 minutes before surgery started)

    Bacterial Colonization

  2. Bacterial Colonization (Gram stain)

    Time frame: at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube )

    Bacterial Colonization

  3. Bacterial Colonization (Gram stain)

    Time frame: after removal of endotracheal tube at recovery room (15 minutes after surgery ended)

    Bacterial Colonization

Secondary outcomes

  1. Breathing odor assessment using questionnaire

    Time frame: at baseline (30 minutes before surgery started)

    Breathing odor assessment

  2. Breathing odor assessment using questionnaire

    Time frame: at insertion of endotracheal tube

    Breathing odor assessment

  3. Breathing odor assessment using questionnaire

    Time frame: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)

    Breathing odor assessment

  4. Breathing odor assessment using halitosis detector

    Time frame: at baseline (30 minutes before surgery started)

    Breathing odor assessment

  5. Breathing odor assessment using halitosis detector

    Time frame: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)

    Breathing odor assessment

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2020
Registry last updated
Feb 5, 2020

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.