NCT04252469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

January 16, 2020

Last Update Submit

January 31, 2020

Conditions

Intratracheal IntubationSurgeryAnesthesia

Keywords

oral careAnesthesiasurgeryIntratracheal Intubation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Breathing odor assessment using questionnaire

    at baseline (30 minutes before surgery started)

  • Breathing odor assessment using questionnaire

    at insertion of endotracheal tube

  • Breathing odor assessment using questionnaire

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

  • Breathing odor assessment using halitosis detector

    at baseline (30 minutes before surgery started)

  • Breathing odor assessment using halitosis detector

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

Study Arms (2)

intervention

EXPERIMENTAL

receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds.

Other: Oral care

Control

NO INTERVENTION

Standardized care

Interventions

Oral careOTHER

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

intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (3)

  • 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.

    PMID: 29766214BACKGROUND

  • 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.

    PMID: 29744564RESULT

  • 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.

    PMID: 30247201RESULT

MeSH Terms

Interventions

Dental Care Team

Intervention Hierarchy (Ancestors)

Patient Care TeamPatient Care ManagementHealth Services Administration

Study Officials

  • Wyee Lee, MSN

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

February 5, 2020

Study Start

May 1, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)