Breast CancerNCT06505850
Cuff Shape and Postoperative Sore Throat in Breast Cancer Patients
A study testing Tapered-shaped cuff tracheal tube and Cylindrical-shaped cuff tracheal tube in people with Breast Cancer and Postoperative Sore Throat, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Postoperative Sore Throat, Subglottic Airway Injury
- What is being tested?
- Tapered-shaped cuff tracheal tube and Cylindrical-shaped cuff tracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jul 2024to 3 Jan 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation
Who cannot join
- Age < 18 years or age > 80 years
- Diseases or anatomic abnormalities in the neck, larynx, or pharynx
- Combined surgery such as breast reconstruction
- Active pulmonary disease
- Morbid obesity (body mass index ≥ 40 kg/m2)
- Pregnancy
- Refusal to join the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons of Postoperative Sore Throat and Subglottic Airway Injury Between Endotracheal Tubes With Different Cuff Shapes in Breast Cancer Patients
This study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat
Read the detailed description
Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.
- Conditions
- Breast Cancer, Postoperative Sore Throat, Subglottic Airway Injury, Endotracheal Tube Cuff
- Being tested
- Tapered-shaped cuff tracheal tube, Cylindrical-shaped cuff tracheal tube
- Keywords
- Endotracheal tube cuff, Postoperative sore throat, Subglottic airway injury, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapered-shaped cuff tracheal tubeDevice
Tracheal intubation with a tapered-shaped cuff tube
Cylindrical-shaped cuff tracheal tubeDevice
Tracheal intubation with a cylindrical-shaped cuff tube
| Study group | Role | What they receive |
|---|---|---|
| Tapered-shaped cuff ETT group | Experimental | A tapered-shaped cuff tube was used to intubate for general anesthesia Receives: Device: Tapered-shaped cuff tracheal tube |
| Cylindrical-shaped cuff ETT group | Active comparator | A cylindrical-shaped cuff tube was used to intubate for general anesthesia Receives: Device: Cylindrical-shaped cuff tracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative sore throat
Measured: Postoperative 48 hours
The severity of postoperative sore throat
1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain)
Measured: Postoperative 48 hours
Secondary outcomes (4)
Intraoperative fentanyl consumption
Measured: The end of surgery
Intraoperative propofol consumption
Measured: The end of surgery
Intraoperative rocuronium consumption
Measured: The end of surgery
The degree of subglottic injury
None: no subglottic injury; mild: mucosal hyperemia and edema and/or slight submucosal hematoma; moderate: moderate submucosal hematoma; severe: mucosal laceration and/or mucosal bleeding)
Measured: Intraoperative (The time point at extubation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start22 Jul 2024
- Primary completion13 Dec 2024
- Study completion3 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-Cheng Tseng, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505850
- Sponsor's protocol ID
- A202405086_V3
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share
Publications
Monroe MC, Gravenstein N, Saga-Rumley S. Postoperative sore throat: effect of oropharyngeal airway in orotracheally intubated patients. Anesth Analg. 1990 May;70(5):512-6. doi: 10.1213/00000539-199005000-00008.
PubMed 2331067Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
PubMed 7880666Biro P, Seifert B, Pasch T. Complaints of sore throat after tracheal intubation: a prospective evaluation. Eur J Anaesthesiol. 2005 Apr;22(4):307-11. doi: 10.1017/s0265021505000529.
PubMed 15892411Lehmann M, Monte K, Barach P, Kindler CH. Postoperative patient complaints: a prospective interview study of 12,276 patients. J Clin Anesth. 2010 Feb;22(1):13-21. doi: 10.1016/j.jclinane.2009.02.015.
PubMed 20206846El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
PubMed 27158989Chang JE, Kim H, Han SH, Lee JM, Ji S, Hwang JY. Effect of Endotracheal Tube Cuff Shape on Postoperative Sore Throat After Endotracheal Intubation. Anesth Analg. 2017 Oct;125(4):1240-1245. doi: 10.1213/ANE.0000000000001933.
PubMed 28368938Chen GC, Lo KL, Wu ZF, Chan SM, Cheng SY, Ko CL, Chu CM, Tseng WC. Comparison of the incidence and severity of postoperative sore throat and subglottic airway injury with cylindrical versus tapered cuff endotracheal tubes in women undergoing surgery for breast cancer: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 12;25(1):181. doi: 10.1186/s12871-025-03040-y.
PubMed 40221641
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Postoperative Sore Throat and Subglottic Airway Injury Between Endotracheal Tubes With Different Cuff Shapes in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06505850
- Acronym / sponsor ID
- A202405086_V3
- Conditions
- Breast Cancer, Postoperative Sore Throat, Subglottic Airway Injury, Endotracheal Tube Cuff
- Keywords
- Endotracheal tube cuff, Postoperative sore throat, Subglottic airway injury, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 3 Jan 2025 (actual)
- First posted
- 17 Jul 2024 (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 study aimed to evaluate the impact of endotracheal tube cuff shapes on the incidence and severity of postoperative sore throat
Detailed description
Postoperative sore throat (POST) is a minor complication after general anesthesia with tracheal intubation but may negatively affect patient satisfaction and postoperative recovery. Due to the multifactorial nature, the detailed mechanism of POST has not been fully understood. However, mucosal irritation and inflammation related to the presence of an ETT within the trachea appear to be one of the primary causes of POST, which may involve elements including the tube size, intracuff pressure, and duration of intubation. In addition, the cuff design of an ETT, which can determine the contact area between the cuff and the tracheal mucosa, is reported to affect the development of POST. This study aimed to evaluate the impact of endotracheal tube (ETT) cuff shapes on the incidence and severity of POST. Additionally, we investigated the influence of ETT cuff shapes on the degree of subglottic injury following GA for breast cancer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tapered-shaped cuff ETT group | Experimental | Device: Tapered-shaped cuff tracheal tubeA tapered-shaped cuff tube was used to intubate for general anesthesia |
| Cylindrical-shaped cuff ETT group | Active comparator | Device: Cylindrical-shaped cuff tracheal tubeA cylindrical-shaped cuff tube was used to intubate for general anesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients scheduled for elective breast cancer surgery performed in the supine position requiring tracheal intubation
Key exclusion criteria (7 listed)
- Age < 18 years or age > 80 years
- Diseases or anatomic abnormalities in the neck, larynx, or pharynx
- Combined surgery such as breast reconstruction
- Active pulmonary disease
- Morbid obesity (body mass index ≥ 40 kg/m2)
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 |
|---|---|---|
| Tapered-shaped cuff tracheal tubeTracheal intubation with a tapered-shaped cuff tube | Device | Tapered-shaped cuff ETT group |
| Cylindrical-shaped cuff tracheal tubeTracheal intubation with a cylindrical-shaped cuff tube | Device | Cylindrical-shaped cuff ETT group |
Primary outcome
The incidence of postoperative sore throat
Time frame: Postoperative 48 hours
The severity of postoperative sore throat
Time frame: Postoperative 48 hours
1, none; 2, mild (complains of sore throat only on asking); 3, moderate (complains of sore throat on her own); 4, severe (change of voice or hoarseness, associated with throat pain)
4 secondary outcomes
Intraoperative fentanyl consumption
Time frame: The end of surgery
Intraoperative propofol consumption
Time frame: The end of surgery
Intraoperative rocuronium consumption
Time frame: The end of surgery
The degree of subglottic injury
Time frame: Intraoperative (The time point at extubation)
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 7 Jan 2025.
- Results publication: PubMed 2331067Monroe MC, Gravenstein N, Saga-Rumley S. Postoperative sore throat: effect of oropharyngeal airway in orotracheally intubated patients. Anesth Analg. 1990 May;70(5):512-6. doi: 10.1213/00000539-199005000-00008.
- Results publication: PubMed 7880666Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.
- Results publication: PubMed 15892411Biro P, Seifert B, Pasch T. Complaints of sore throat after tracheal intubation: a prospective evaluation. Eur J Anaesthesiol. 2005 Apr;22(4):307-11. doi: 10.1017/s0265021505000529.
- Results publication: PubMed 20206846Lehmann M, Monte K, Barach P, Kindler CH. Postoperative patient complaints: a prospective interview study of 12,276 patients. J Clin Anesth. 2010 Feb;22(1):13-21. doi: 10.1016/j.jclinane.2009.02.015.
- Results publication: PubMed 27158989El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Results publication: PubMed 28368938Chang JE, Kim H, Han SH, Lee JM, Ji S, Hwang JY. Effect of Endotracheal Tube Cuff Shape on Postoperative Sore Throat After Endotracheal Intubation. Anesth Analg. 2017 Oct;125(4):1240-1245. doi: 10.1213/ANE.0000000000001933.
- Derived from this study: PubMed 40221641Chen GC, Lo KL, Wu ZF, Chan SM, Cheng SY, Ko CL, Chu CM, Tseng WC. Comparison of the incidence and severity of postoperative sore throat and subglottic airway injury with cylindrical versus tapered cuff endotracheal tubes in women undergoing surgery for breast cancer: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 12;25(1):181. doi: 10.1186/s12871-025-03040-y.
- Individual participant dataSharing planned: No. There is no plan to share
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tapered-shaped cuff tracheal tube and Cylindrical-shaped cuff tracheal tube in people with Breast Cancer and Postoperative Sore Throat, run by Tri-Service General Hospital (TSGH) 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 7 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 7 Jan 2025. 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?
The incidence of postoperative sore throat (time frame: Postoperative 48 hours). 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?
On the ClinicalTrials.gov record for NCT06505850, which also lists 7 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 7 Jan 2025.