Clinical trial NCT04252469: Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
Official title: Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intratracheal Intubation
Surgery
Anesthesia
Keywords: oral care
Anesthesia
surgery
Intratracheal Intubation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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,

Primary outcomes:
measure: Bacterial Colonization (Gram stain)
timeFrame: at baseline (30 minutes before surgery started)
measure: Bacterial Colonization (Gram stain)
timeFrame: at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube )
measure: Bacterial Colonization (Gram stain)
timeFrame: after removal of endotracheal tube at recovery room (15 minutes after surgery ended)
Secondary outcomes:
measure: Breathing odor assessment using questionnaire
timeFrame: at baseline (30 minutes before surgery started)
measure: Breathing odor assessment using questionnaire
timeFrame: at insertion of endotracheal tube
measure: Breathing odor assessment using questionnaire
timeFrame: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
measure: Breathing odor assessment using halitosis detector
timeFrame: at baseline (30 minutes before surgery started)
measure: Breathing odor assessment using halitosis detector
timeFrame: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wyee Lee, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.