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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
126
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.
Hitit University Erol Olçok Training and Research Hospital
Çorum, Turkey (Türkiye)
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
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