Intratracheal IntubationNCT04252469
Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
A study testing Oral care in people with Intratracheal Intubation and Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intratracheal Intubation, Surgery, Anesthesia
- What is being tested?
- Oral care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Intratracheal Intubation, Surgery, Anesthesia
- Being tested
- Oral care
- Keywords
- oral care, Anesthesia, surgery, Intratracheal Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral careOther
oral care using 20mL of 0.12% CHX and gargling with 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | receiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds. Receives: Other: Oral care |
| Control | No intervention | Standardized care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Colonization (Gram stain)
Bacterial Colonization
Measured: at baseline (30 minutes before surgery started)
Bacterial Colonization (Gram stain)
Bacterial Colonization
Measured: at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube )
Bacterial Colonization (Gram stain)
Bacterial Colonization
Measured: after removal of endotracheal tube at recovery room (15 minutes after surgery ended)
Secondary outcomes (5)
Breathing odor assessment using questionnaire
Breathing odor assessment
Measured: at baseline (30 minutes before surgery started)
Breathing odor assessment using questionnaire
Breathing odor assessment
Measured: at insertion of endotracheal tube
Breathing odor assessment using questionnaire
Breathing odor assessment
Measured: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
Breathing odor assessment using halitosis detector
Breathing odor assessment
Measured: at baseline (30 minutes before surgery started)
Breathing odor assessment using halitosis detector
Breathing odor assessment
Measured: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 May 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intratracheal IntubationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wyee Lee, MSN, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252469
- Sponsor's protocol ID
- 201806086RINB
- Status last verified
- Jan 2020
- First submitted
- 16 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29766214Deschepper 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.
PubMed 29744564La 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.
PubMed 30247201
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pre-intubation Chlorhexidine Oral Care on Health Outcomes
- ClinicalTrials.gov ID
- NCT04252469
- Acronym / sponsor ID
- 201806086RINB
- Conditions
- Intratracheal Intubation, Surgery, Anesthesia
- Keywords
- oral care, Anesthesia, surgery, Intratracheal Intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Oral carereceiving oral care with 20mL of 0.12% CHX by medicine cup, gargling 30 seconds. |
| Control | No intervention | –Standardized care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-80 years of age, American Society of Anesthesiologists, ASA) class 1-3, scheduled for surgery under endotracheal tube intubation general anesthesia.
Key exclusion criteria (1 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral careoral care using 20mL of 0.12% CHX and gargling with 30 seconds. | Other | intervention |
Primary outcome
Bacterial Colonization (Gram stain)
Time frame: at baseline (30 minutes before surgery started)
Bacterial Colonization
Bacterial Colonization (Gram stain)
Time frame: at removal of endotracheal tube (3 minutes after surgery ended and removal of endotracheal tube )
Bacterial Colonization
Bacterial Colonization (Gram stain)
Time frame: after removal of endotracheal tube at recovery room (15 minutes after surgery ended)
Bacterial Colonization
5 secondary outcomes
Breathing odor assessment using questionnaire
Time frame: at baseline (30 minutes before surgery started)
Breathing odor assessment using questionnaire
Time frame: at insertion of endotracheal tube
Breathing odor assessment using questionnaire
Time frame: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
Breathing odor assessment using halitosis detector
Time frame: at baseline (30 minutes before surgery started)
Breathing odor assessment using halitosis detector
Time frame: after removal of endotracheal tube and at recovery room (15 minutes after surgery ended)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 29766214Ricard 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.
- Results publication: PubMed 29744564Deschepper 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.
- Results publication: PubMed 30247201La 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wyee Lee, MSN principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral care in people with Intratracheal Intubation and Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Colonization (Gram stain) (time frame: at baseline (30 minutes before surgery started)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252469, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.