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Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252469
Recruitment Status : Completed
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Intratracheal Intubation Surgery Anesthesia Other: Oral care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
Actual Study Start Date : May 1, 2019
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019

Arm Intervention/treatment
Experimental: intervention
receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds.
Other: Oral care
oral care using 20mL of 0.12% CHX and gargling with 30 seconds.

No Intervention: Control
Standardized care



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252469


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wyee Lee, MSN National Taiwan University Hospital
Publications of Results:
Other Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04252469    
Other Study ID Numbers: 201806086RINB
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
oral care
Anesthesia
surgery
Intratracheal Intubation