Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Surgery Clinical Trial

Official title:

Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252469
• Other study ID #: 201806086RINB
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anesthesia
• Intratracheal Intubation
• Surgery

Intervention

Other:
• Oral care
oral care using 20mL of 0.12% CHX and gargling with 30 seconds.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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 2 — View Citation

La Combe B, Mahérault 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Colonization (Gram stain)	Bacterial Colonization	at baseline (30 minutes before surgery started)
Primary	Bacterial Colonization (Gram stain)	Bacterial Colonization	at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube )
Primary	Bacterial Colonization (Gram stain)	Bacterial Colonization	after removal of endotracheal tube at recovery room (15 minutes after surgery ended)
Secondary	Breathing odor assessment using questionnaire	Breathing odor assessment	at baseline (30 minutes before surgery started)
Secondary	Breathing odor assessment using questionnaire	Breathing odor assessment	at insertion of endotracheal tube
Secondary	Breathing odor assessment using questionnaire	Breathing odor assessment	after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
Secondary	Breathing odor assessment using halitosis detector	Breathing odor assessment	at baseline (30 minutes before surgery started)
Secondary	Breathing odor assessment using halitosis detector	Breathing odor assessment	after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)