An interventional study of Handheld Endotracheal Tube Cuff Manometer and Pilot-Balloon Palpation in Postoperative Sore Throat and Endotracheal Intubation, sponsored by Hitit University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Hitit University · Not applicable, Interventional, and Prevention
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.
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.
52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.
This study's enrollment of 126 is above the median of 108 across 44 interventional studies indexed under Hoarseness.
Browse Hoarseness studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Handheld Endotracheal Tube Cuff Manometer
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.
Procedure: Pilot-Balloon Palpation
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.
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.
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.
Time frame: From 1 hour to 24 hours after extubation
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.
Time frame: 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.
Time frame: 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.
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
The proportion of cuff-pressure measurements within the predefined target range of 25-30 cmH₂O was evaluated at the scheduled intraoperative measurement time points.
Time frame: Immediately after intubation, 10 minutes after intubation, 1 hour after intubation, and immediately before extubation
Occurrence of Postoperative Hoarseness
Postoperative hoarseness was assessed following extubation.
Time frame: Within 24 hours after extubation
Occurrence of Postoperative Dysphagia
Postoperative difficulty swallowing (dysphagia) was assessed following extubation.
Time frame: Within 24 hours after extubation
Occurrence of Postoperative Cough
Postoperative cough was assessed following extubation.
Time frame: Within 24 hours after extubation
Occurrence of Postoperative Nausea or Vomiting
Postoperative nausea or vomiting was assessed following surgery.
Time frame: within 24 hours after extubation
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data and supporting documents will be available after publication of the primary study results and may remain available for a reasonable period thereafter, subject to institutional and ethical approval.
Access criteria: Qualified researchers with a scientifically sound proposal may request access to de-identified individual participant data and supporting documents. Requests will be reviewed by the corresponding author and, when required, by the relevant institution. Access will be granted only after appropriate approval and under conditions that protect participant confidentiality.
No publications or documents are linked to this record.
Ran from May 2025 to primary completion in Nov 2025, 6 months.
Of 21 interventional studies with no phase under Hoarseness, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 24. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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