Postoperative Sore ThroatNCT07842081
Scheduled Endotracheal Tube Cuff Pressure Management and Postoperative Sore Throat
A study testing Handheld Endotracheal Tube Cuff Manometer and Pilot-Balloon Palpation in people with Postoperative Sore Throat and Endotracheal Intubation, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sore Throat, Endotracheal Intubation
- What is being tested?
- Handheld Endotracheal Tube Cuff Manometer and Pilot-Balloon Palpation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2025to 18 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective surgery under general anesthesia with planned endotracheal intubation.
- Provided written informed consent.
Who cannot join
- Active upper respiratory tract infection on the day of surgery.
- Anticipated difficult airway.
- Anatomical laryngotracheal abnormality.
- Previous surgery or radiotherapy involving the laryngotracheal region.
- Anticipated need for postoperative tracheal intubation lasting more than 24 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Erol Olçok Training and Research Hospital
Çorum, Çorum, 19030
About this study
Official title: Scheduled Manometer-Guided Endotracheal Tube Cuff-Pressure Management Versus Pilot-Balloon Palpation for Reducing Postoperative Sore Throat in Adults Undergoing Elective Surgery With Tracheal Intubation: A Randomized Controlled Trial
This randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation.
Participants were randomly assigned in a 1:1 ratio to either manometer-guided cuff-pressure management or conventional cuff inflation based on pilot-balloon palpation. In the manometer-guided group, cuff pressure was maintained within a target range of 25-30 cmH₂O. In the conventional group, cuff inflation was managed according to the attending anesthesiologist's usual clinical assessment.
Read more
Cuff pressure was assessed at predefined time points during anesthesia. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation. Other postoperative airway symptoms, including hoarseness, difficulty swallowing, cough, and postoperative nausea or vomiting, were also assessed.
The main objective was to determine whether scheduled manometer-guided cuff-pressure management reduced the occurrence of postoperative sore throat within the first 24 hours after surgery compared with conventional pilot-balloon palpation.
Read the detailed description
This was a prospective, randomized, parallel-group controlled trial conducted in adults undergoing elective surgery under general anesthesia with planned endotracheal intubation.
Eligible participants were randomized in a 1:1 ratio to one of two cuff-pressure management strategies.
In the manometer-guided group, endotracheal tube cuff pressure was initially adjusted to a target range of 25-30 cmH₂O using a calibrated handheld cuff manometer. Cuff pressure was subsequently assessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At each scheduled assessment after the initial adjustment, cuff pressure was recorded before adjustment and was readjusted to 25-30 cmH₂O when necessary.
In the conventional pilot-balloon palpation group, cuff inflation was performed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured using the same manometer at the predefined study time points for study documentation, but the measured values were not used to guide cuff-pressure adjustment.
Postoperative outcomes were assessed by an investigator blinded to treatment allocation. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation using a 10-point numerical rating scale. The primary outcome was the occurrence of any postoperative sore throat within 24 hours. Additional postoperative airway symptoms and cuff-pressure-related outcomes were also evaluated.
Clarification regarding the 1-hour cuff-pressure assessment:
The study protocol included cuff-pressure assessments immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation.
In the study dataset, the nominal 1-hour measurement field also contained pre-extubation measurements from participants extubated before 60 minutes. Because exact intubation and extubation timestamps were unavailable, it was not possible to reliably distinguish scheduled 1-hour measurements from these earlier terminal measurements.
Consequently, the nominal 1-hour field was excluded from fixed-time between-group statistical comparisons. The original recorded values were retained in the study dataset. Comparative analyses of cuff pressure were performed using the three reliably identifiable assessment points: after initial cuff inflation, 10 minutes after intubation, and immediately before extubation.
This clarification concerns the analysis of the recorded measurements and does not represent a retrospective change to the originally planned measurement schedule.
- Conditions
- Postoperative Sore Throat, Endotracheal Intubation
- Being tested
- Handheld Endotracheal Tube Cuff Manometer, Pilot-Balloon Palpation
- Keywords
- Endotracheal Intubation, Endotracheal Tube Cuff Pressure, Cuff Manometer, Pilot Balloon Palpation, General Anesthesia, Postoperative Airway Symptoms, Hoarseness, Dysphagia
- Medical subject headings
- Hoarseness, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handheld Endotracheal Tube Cuff ManometerDevice
Endotracheal tube cuff pressure was measured using a handheld cuff manometer and adjusted to a target range of 25-30 cmH₂O. Measurements were performed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation.
Pilot-Balloon PalpationProcedure or surgery
Endotracheal tube cuff inflation was managed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only, without pressure-directed adjustment.
| Study group | Role | What they receive |
|---|---|---|
| Manometer-Guided Cuff Pressure Management | Experimental | Participants assigned to this arm underwent scheduled endotracheal tube cuff-pressure measurement using a handheld cuff manometer. Cuff pressure was initially adjusted to 25-30 cmH₂O and was reassessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At subsequent assessments, cuff pressure was readjusted to the target range when necessary. Receives: Device: Handheld Endotracheal Tube Cuff Manometer |
| Pilot-Balloon Palpation | Active comparator | Participants assigned to this arm underwent conventional endotracheal tube cuff inflation based on the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only and was not used to guide pressure adjustment. Receives: Procedure: Pilot-Balloon Palpation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Postoperative Sore Throat Within 24 Hours
Postoperative sore throat was assessed using a 10-point numerical rating scale (NRS) at 1, 6, and 24 hours after extubation. The primary outcome was defined as the occurrence of any postoperative sore throat within 24 hours, corresponding to an NRS score greater than 1 at any scheduled assessment.
Measured: From 1 hour to 24 hours after extubation
Secondary outcomes (4)
Postoperative Sore Throat Severity at 1, 6, and 24 Hours
Postoperative sore throat severity was assessed using a 10-point numerical rating scale (NRS), where 1 indicated no sore throat and higher scores indicated increasing symptom severity.
Measured: 1, 6, and 24 hours after extubation
Postoperative Sore Throat Occurrence at Individual Time Points
The occurrence of postoperative sore throat was evaluated separately at 1, 6, and 24 hours after extubation.
Measured: 1, 6, and 24 hours after extubation
Endotracheal Tube Cuff Pressure at Scheduled Intraoperative Time Points
Endotracheal tube cuff pressure was measured using a handheld cuff manometer immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. Cuff-pressure values were compared between the study groups.
Measured: Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation
Proportion of Cuff Pressure Measurements Within the Target Range
The proportion of cuff-pressure measurements within the predefined target range of 25-30 cmH₂O was evaluated at the scheduled intraoperative measurement time points.
Measured: Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start13 May 2025
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Model description
- Participants were randomized in a 1:1 ratio to either scheduled manometer-guided endotracheal tube cuff-pressure management or conventional pilot-balloon palpation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veysel Barış TURHAN, Hitit University
- Investigators
- Semin Turhan, Principal investigator, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842081
- Sponsor's protocol ID
- HITIT-ETT-CUFF-2025-01
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study may be shared with qualified researchers upon reasonable request, subject to institutional approval, applicable ethical requirements, and protection of participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scheduled Manometer-Guided Endotracheal Tube Cuff-Pressure Management Versus Pilot-Balloon Palpation for Reducing Postoperative Sore Throat in Adults Undergoing Elective Surgery With Tracheal Intubation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07842081
- Acronym / sponsor ID
- HITIT-ETT-CUFF-2025-01
- Conditions
- Postoperative Sore Throat, Endotracheal Intubation
- Keywords
- Endotracheal Intubation, Endotracheal Tube Cuff Pressure, Cuff Manometer, Pilot Balloon Palpation, General Anesthesia, Postoperative Airway Symptoms, Hoarseness, Dysphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 25 Sep 2026 (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 randomized controlled trial evaluated whether scheduled measurement and adjustment of endotracheal tube cuff pressure using a handheld manometer could reduce postoperative sore throat in adults undergoing elective surgery under general anesthesia with tracheal intubation.
Participants were randomly assigned in a 1:1 ratio to either manometer-guided cuff-pressure management or conventional cuff inflation based on pilot-balloon palpation. In the manometer-guided group, cuff pressure was maintained within a target range of 25-30 cmH₂O. In the conventional group, cuff inflation was managed according to the attending anesthesiologist's usual clinical assessment.
Cuff pressure was assessed at predefined time points during anesthesia. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation. Other postoperative airway symptoms, including hoarseness, difficulty swallowing, cough, and postoperative nausea or vomiting, were also assessed.
The main objective was to determine whether scheduled manometer-guided cuff-pressure management reduced the occurrence of postoperative sore throat within the first 24 hours after surgery compared with conventional pilot-balloon palpation.
Detailed description
This was a prospective, randomized, parallel-group controlled trial conducted in adults undergoing elective surgery under general anesthesia with planned endotracheal intubation.
Eligible participants were randomized in a 1:1 ratio to one of two cuff-pressure management strategies.
In the manometer-guided group, endotracheal tube cuff pressure was initially adjusted to a target range of 25-30 cmH₂O using a calibrated handheld cuff manometer. Cuff pressure was subsequently assessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At each scheduled assessment after the initial adjustment, cuff pressure was recorded before adjustment and was readjusted to 25-30 cmH₂O when necessary.
In the conventional pilot-balloon palpation group, cuff inflation was performed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured using the same manometer at the predefined study time points for study documentation, but the measured values were not used to guide cuff-pressure adjustment.
Postoperative outcomes were assessed by an investigator blinded to treatment allocation. Postoperative sore throat was evaluated at 1, 6, and 24 hours after extubation using a 10-point numerical rating scale. The primary outcome was the occurrence of any postoperative sore throat within 24 hours. Additional postoperative airway symptoms and cuff-pressure-related outcomes were also evaluated.
Clarification regarding the 1-hour cuff-pressure assessment:
The study protocol included cuff-pressure assessments immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation.
In the study dataset, the nominal 1-hour measurement field also contained pre-extubation measurements from participants extubated before 60 minutes. Because exact intubation and extubation timestamps were unavailable, it was not possible to reliably distinguish scheduled 1-hour measurements from these earlier terminal measurements.
Consequently, the nominal 1-hour field was excluded from fixed-time between-group statistical comparisons. The original recorded values were retained in the study dataset. Comparative analyses of cuff pressure were performed using the three reliably identifiable assessment points: after initial cuff inflation, 10 minutes after intubation, and immediately before extubation.
This clarification concerns the analysis of the recorded measurements and does not represent a retrospective change to the originally planned measurement schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to either scheduled manometer-guided endotracheal tube cuff-pressure management or conventional pilot-balloon palpation.
| Arm | Type | Receives |
|---|---|---|
| Manometer-Guided Cuff Pressure Management | Experimental | Device: Handheld Endotracheal Tube Cuff ManometerParticipants assigned to this arm underwent scheduled endotracheal tube cuff-pressure measurement using a handheld cuff manometer. Cuff pressure was initially adjusted to 25-30 cmH₂O and was reassessed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. At subsequent assessments, cuff pressure was readjusted to the target range when necessary. |
| Pilot-Balloon Palpation | Active comparator | Procedure: Pilot-Balloon PalpationParticipants assigned to this arm underwent conventional endotracheal tube cuff inflation based on the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only and was not used to guide pressure adjustment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective surgery under general anesthesia with planned endotracheal intubation.
- Provided written informed consent.
Key exclusion criteria (5 listed)
- Active upper respiratory tract infection on the day of surgery.
- Anticipated difficult airway.
- Anatomical laryngotracheal abnormality.
- Previous surgery or radiotherapy involving the laryngotracheal region.
- Anticipated need for postoperative tracheal intubation lasting more than 24 hours.
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 |
|---|---|---|
| Handheld Endotracheal Tube Cuff ManometerEndotracheal tube cuff pressure was measured using a handheld cuff manometer and adjusted to a target range of 25-30 cmH₂O. Measurements were performed immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation. | Device | Manometer-Guided Cuff Pressure Management |
| Pilot-Balloon PalpationEndotracheal tube cuff inflation was managed according to the attending anesthesiologist's subjective assessment of the pilot balloon. Cuff pressure was measured at the predefined study time points for study documentation only, without pressure-directed adjustment. | Procedure or surgery | Pilot-Balloon Palpation |
Primary outcome
Occurrence of Postoperative Sore Throat Within 24 Hours
Time frame: From 1 hour to 24 hours after extubation
Postoperative sore throat was assessed using a 10-point numerical rating scale (NRS) at 1, 6, and 24 hours after extubation. The primary outcome was defined as the occurrence of any postoperative sore throat within 24 hours, corresponding to an NRS score greater than 1 at any scheduled assessment.
4 secondary outcomes
Postoperative Sore Throat Severity at 1, 6, and 24 Hours
Time frame: 1, 6, and 24 hours after extubation
Postoperative Sore Throat Occurrence at Individual Time Points
Time frame: 1, 6, and 24 hours after extubation
Endotracheal Tube Cuff Pressure at Scheduled Intraoperative Time Points
Time frame: Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation
Proportion of Cuff Pressure Measurements Within the Target Range
Time frame: Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before 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 29 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study may be shared with qualified researchers upon reasonable request, subject to institutional approval, applicable ethical requirements, and protection of participant confidentiality.
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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.
Semin Turhan principal investigator
Hitit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handheld Endotracheal Tube Cuff Manometer and Pilot-Balloon Palpation in people with Postoperative Sore Throat and Endotracheal Intubation, run by Hitit University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 29 Oct 2026. 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 Turkey (Türkiye). 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?
Occurrence of Postoperative Sore Throat Within 24 Hours (time frame: From 1 hour to 24 hours after extubation). 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 29 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.