Laparoscopic SurgeryNCT05542823
Effect of Cuff Pressure of Endotracheal Tube on POST
An observational study of Laparoscopic Surgery and Tracheal Intubation Morbidity, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Laparoscopic Surgery, Tracheal Intubation Morbidity, Sore-throat
- How many people
- 337 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 4 Oct 2022to 10 Aug 2025
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia
Who may be able to join
- Patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia
Who cannot join
- Patients who already had sore throat and hoarseness before surgery
- Patients who were expected to have anticipated difficult airway
- Surgery duration < 1 hour
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul national university hospital
Seoul, Please Select An Option, 03080
Hyun-Kyu Yoon
Seoul
About this study
Official title: Effect of Cuff Pressure of Endotracheal Tube on Postoperative Sore Throat: a Prospective Observational Study
The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.
Read the detailed description
For patients undergoing laparoscopic surgery after tracheal intubation, continuous cuff pressure monitoring is performed by connecting a pressure monitor to the cuff of the endotracheal tube. The incidence of postoperative sore throat was evaluated via direct questioning in all patients. This study aimed to investigate the association between the development of postoperative sore throat and the duration of overpressure in the cuff of the endotracheal tube.
- Keywords
- Laparoscopic surgery, Endotracheal intubation, Cuff pressure, Sore throat, Hoarseness
- Medical subject headings
- Pharyngitis, Hoarseness
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative sore throat at 24h postoperatively.
Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat
- = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold)
- = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold)
- = severe (more severe than with a cold)3 = severe (more severe than with a cold)
Measured: at 24h postoperatively.
Secondary outcomes (5)
Incidence of postoperative sore throat at 1h postoperatively.
Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat
- = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold)
- = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold)
- = severe (more severe than with a cold)3 = severe (more severe than with a cold)
Measured: at 1h postoperatively
Incidence of postoperative sore throat at 48h postoperatively.
Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat
- = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold)
- = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold)
- = severe (more severe than with a cold)3 = severe (more severe than with a cold)
Measured: at 48h postoperatively
Incidence of postoperative hoarseness at 1h postoperatively.
Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness
- = mild hoarseness (noticed by the patient only)
- = severe hoarseness (noticed by the time of the interview by the personnel)
- = aphonia (inability to speak)
Measured: at 1h postoperatively
Incidence of postoperative hoarseness at 24h postoperatively.
Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness
- = mild hoarseness (noticed by the patient only)
- = severe hoarseness (noticed by the time of the interview by the personnel)
- = aphonia (inability to speak)
Measured: at 24h postoperatively.
Incidence of postoperative hoarseness at 48h postoperatively.
Incidence of postoperative hoarseness (score 1 or more) 0 = no hoarseness
- = mild hoarseness (noticed by the patient only)
- = severe hoarseness (noticed by the time of the interview by the personnel)
- = aphonia (inability to speak)
Measured: at 48h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start4 Oct 2022
- Primary completion7 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Kyu Yoon, Seoul National University Hospital
- Investigators
- Hyun-Kyu Yoon, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542823
- Sponsor's protocol ID
- POST_cuff_pressure
- Status last verified
- Jan 2026
- First submitted
- 13 Sep 2022
- Last updated
- 12 Jan 2026
- 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cuff Pressure of Endotracheal Tube on Postoperative Sore Throat: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05542823
- Acronym / sponsor ID
- POST_cuff_pressure
- Keywords
- Laparoscopic surgery, Endotracheal intubation, Cuff pressure, Sore throat, Hoarseness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 16 Sep 2022 (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.
The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.
Detailed description
For patients undergoing laparoscopic surgery after tracheal intubation, continuous cuff pressure monitoring is performed by connecting a pressure monitor to the cuff of the endotracheal tube. The incidence of postoperative sore throat was evaluated via direct questioning in all patients. This study aimed to investigate the association between the development of postoperative sore throat and the duration of overpressure in the cuff of the endotracheal tube.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia
Key inclusion criteria (1 listed)
- Patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia
Key exclusion criteria (3 listed)
- Patients who already had sore throat and hoarseness before surgery
- Patients who were expected to have anticipated difficult airway
- Surgery duration < 1 hour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative sore throat at 24h postoperatively.
Time frame: at 24h postoperatively.
Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat 1. = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold) 2. = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold) 3. = severe (more severe than with a cold)3 = severe (more severe than with a cold)
5 secondary outcomes
Incidence of postoperative sore throat at 1h postoperatively.
Time frame: at 1h postoperatively
Incidence of postoperative sore throat at 48h postoperatively.
Time frame: at 48h postoperatively
Incidence of postoperative hoarseness at 1h postoperatively.
Time frame: at 1h postoperatively
Incidence of postoperative hoarseness at 24h postoperatively.
Time frame: at 24h postoperatively.
Incidence of postoperative hoarseness at 48h postoperatively.
Time frame: at 48h postoperatively
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 12 Jan 2026.
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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.
Hyun-Kyu Yoon principal investigator
Seoul National University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery and Tracheal Intubation Morbidity, run by Seoul National University Hospital at 2 sites in South Korea.
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 3 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 12 Jan 2026. 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 South Korea. 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?
Incidence of postoperative sore throat at 24h postoperatively. (time frame: at 24h postoperatively.). 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 12 Jan 2026.