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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds. |
|
| Control | No Intervention | Standardized care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral care | Other | oral care using 20mL of 0.12% CHX and gargling with 30 seconds. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wyee Lee, MSN | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29766214 | Background | 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. | |
| 29744564 | Result | 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. |
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| ID | Term |
|---|---|
| D000091982 | Dental Care Team |
| ID | Term |
|---|---|
| D010348 | Patient Care Team |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| 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) |
| 30247201 | Result | 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. |