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.

Study Overview

• Status: Completed
• Conditions: Surgery; Anesthesia; Intratracheal Intubation
• Intervention / Treatment: Other: Oral care

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 Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wyee Lee, MSN, National Taiwan University Hospital

Publications and helpful links

General Publications

• Ricard JD, Lisboa T. Caution for chlorhexidine gluconate use for oral care: insufficient data. Intensive Care Med. 2018 Jul;44(7):1162-1164. doi: 10.1007/s00134-018-5217-6. Epub 2018 May 15. No abstract available.
• Deschepper M, Waegeman W, Eeckloo K, Vogelaers D, Blot S. Effects of chlorhexidine gluconate oral care on hospital mortality: a hospital-wide, observational cohort study. Intensive Care Med. 2018 Jul;44(7):1017-1026. doi: 10.1007/s00134-018-5171-3. Epub 2018 May 9.
• La Combe B, Maherault AC, Messika J, Billard-Pomares T, Branger C, Landraud L, Dreyfuss D, Dib F, Massias L, Ricard JD. Oropharyngeal Bacterial Colonization after Chlorhexidine Mouthwash in Mechanically Ventilated Critically Ill Patients. Anesthesiology. 2018 Dec;129(6):1140-1148. doi: 10.1097/ALN.0000000000002451.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 31, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: surgery; Anesthesia; oral care; Intratracheal Intubation
• Other Study ID Numbers: 201806086RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No