Sore ThroatNCT04184778
Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
A study testing Smaller tube size in people with Sore Throat and Hoarseness, run by Regionshospital Nordjylland at 2 sites in Denmark.
Trial summary
How tube size affect patient's experience of postoperative sore throat and hoarseness Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat, Hoarseness
- What is being tested?
- Smaller tube size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2019to 31 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need for intubation
- Elective surgery
- ASA Group I and II
- Understands and speaks Danish
- give one's consent
Who cannot join
- Known dementia
- SARI score >4
- BMI > 35
- Acute intubation
- attempt intubation > 2
- known with previously difficult intubation
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
North Denmark Regional Hospital
Hjørring, 9800
Aalborg University Hospital
Thisted, 7700
About this study
How tube size affect patient's experience of postoperative sore throat and hoarseness
Read the detailed description
A randomised controlled study studying how tube size affect patient's experience of postoperative sore throat and hoarseness.
The patients are randomised on the basis of gender. Men are randomized to tube size 8.0 (usual) or 7.0. Women are randomized to tube size 7.0 (usual) or 6.0.
- Conditions
- Sore Throat, Hoarseness
- Being tested
- Smaller tube size
- Keywords
- postoperative, Tube size, Patient experience
- Medical subject headings
- Pharyngitis, Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smaller tube sizeDevice
Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.
| Study group | Role | What they receive |
|---|---|---|
| Woman tube size 6.0 | Experimental | Smaller tube than normal Receives: Device: Smaller tube size |
| Woman tube size 7.0 | No intervention | Usual tube size |
| Man tube size 7.0 | Experimental | Smaller tube than normal Receives: Device: Smaller tube size |
| Man tube size 8.0 | No intervention | Usual tube size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sore throat after intubation
Survey - experienced postoperative sore throat after intubation. A scale from 1-4 is used; 1 indicated no sore throat and 4 indicated seriously sore throat.
Measured: 7 days
Hoarseness after intubation
Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dorte Melgaard Kristiansen, Regionshospital Nordjylland
- Investigators
- Dorte M Kristensen, PhD, Principal investigator, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184778
- Sponsor's protocol ID
- RHN_DMK_06
- Status last verified
- Jun 2021
- First submitted
- 10 Apr 2019
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness
- ClinicalTrials.gov ID
- NCT04184778
- Acronym / sponsor ID
- RHN_DMK_06
- Conditions
- Sore Throat, Hoarseness
- Keywords
- postoperative, Tube size, Patient experience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 Dec 2019 (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.
How tube size affect patient's experience of postoperative sore throat and hoarseness
Detailed description
A randomised controlled study studying how tube size affect patient's experience of postoperative sore throat and hoarseness.
The patients are randomised on the basis of gender. Men are randomized to tube size 8.0 (usual) or 7.0. Women are randomized to tube size 7.0 (usual) or 6.0.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Woman tube size 6.0 | Experimental | Device: Smaller tube sizeSmaller tube than normal |
| Woman tube size 7.0 | No intervention | –Usual tube size |
| Man tube size 7.0 | Experimental | Device: Smaller tube sizeSmaller tube than normal |
| Man tube size 8.0 | No intervention | –Usual tube size |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Need for intubation
- Elective surgery
- ASA Group I and II
- Understands and speaks Danish
- give one's consent
Key exclusion criteria (6 listed)
- Known dementia
- SARI score >4
- BMI > 35
- Acute intubation
- attempt intubation > 2
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 |
|---|---|---|
| Smaller tube sizeComparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women. | Device | Man tube size 7.0, Woman tube size 6.0 |
Primary outcome
Sore throat after intubation
Time frame: 7 days
Survey - experienced postoperative sore throat after intubation. A scale from 1-4 is used; 1 indicated no sore throat and 4 indicated seriously sore throat.
Hoarseness after intubation
Time frame: 7 days
Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.
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 10 Jun 2021.
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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.
Dorte M Kristensen, PhD principal investigator
Regionshospital Nordjylland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smaller tube size in people with Sore Throat and Hoarseness, run by Regionshospital Nordjylland at 2 sites in Denmark.
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 5 inclusion and 6 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 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Sore throat after intubation (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.