About this trial
During shoulder arthroscopy, fluid is pumped into the shoulder to help the surgeon see inside the joint. Some of this fluid can move into the tissues around the shoulder and neck and cause swelling. During general anesthesia, a breathing tube is placed in the windpipe. This tube has a small inflatable balloon, called a cuff, whose pressure may increase when the surrounding tissues swell.
The purpose of this study is to determine whether larger amounts of irrigation fluid used during shoulder arthroscopy are associated with greater increases in breathing tube cuff pressure and neck soft tissue thickness.
About 60 adults undergoing planned shoulder arthroscopy in the beach-chair position will take part. The study will not change the participants' anesthesia, surgery, or treatment. Researchers will record the amount of irrigation fluid used, measure cuff pressure at set times during surgery, and measure the neck before and after surgery using ultrasound and a measuring tape. Sore throat, hoarseness, and other airway symptoms will be assessed after surgery. Participants will be followed until six hours after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 75 years
American Society of Anesthesiologists physical status I-III
Scheduled for elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation
Able to read and understand Turkish and provide written informed consent
Disqualifiers
Emergency surgery
Pregnancy
Preoperative hoarseness, sore throat, or dysphagia
Upper respiratory tract infection within the previous 2 weeks
Trial population
The study population will consist of adult patients scheduled for elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation at Fatih Sultan Mehmet Training and Research Hospital. Consecutive patients will be screened preoperatively, and eligible patients who provide written informed consent will be enrolled. Participants of all biological sexes with American Society of Anesthesiologists physical status I-III will be included. The study is observational and will not alter routine surgical or anesthesia management.
Trial design
Cohort
Prospective
Treatments tested in this trial
Elective Shoulder Arthroscopy
Procedure/SurgeryParticipants will undergo elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation as part of routine clinical care. The study will not assign or modify the surgical indication, arthroscopic procedure, patient positioning, irrigation fluid, irrigation pump settings, or anesthesia management. Researchers will observe and record the total irrigation fluid volume and will perform serial endotracheal tube cuff pressure measurements and preoperative and postoperative assessments of anterior neck soft tissue thickness and neck circumference.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Increase in Endotracheal Tube Cuff Pressure (ΔPmax)
After the participant is placed in the beach-chair position, endotracheal tube cuff pressure will be adjusted to a standardized baseline of 25 cmH2O. Cuff pressure will then be measured immediately before readjustment at 15, 30, 45, and 60 minutes after the start of irrigation, every 30 minutes thereafter, and at the end of surgery. ΔPmax, expressed in cmH2O, will be calculated as the highest cuff pressure recorded during surgery minus the standardized baseline pressure of 25 cmH2O. Higher values indicate a greater increase in cuff pressure. The association between ΔPmax and total irrigation fluid volume, recorded in liters, will be evaluated.
Secondary outcomes
Maximum Endotracheal Tube Cuff Pressure
The highest endotracheal tube cuff pressure recorded in each participant at any prespecified intraoperative measurement time point before the pressure is readjusted to 25 cmH2O. The outcome will be reported in cmH2O. Higher values indicate greater maximum cuff pressure.
Occurrence of Endotracheal Tube Cuff Pressure Above 30 cmH2O
The occurrence of at least one endotracheal tube cuff pressure measurement greater than 30 cmH2O before pressure readjustment at any prespecified intraoperative time point. The outcome will be reported as the number and percentage of participants with at least one measurement above 30 cmH2O.
Change in Anterior Neck Soft Tissue Thickness
Anterior neck soft tissue thickness will be measured by ultrasonography at the level of the cricoid cartilage, from the skin to the anterior tracheal air-mucosa interface. Three measurements will be obtained before anesthesia and after surgery before extubation, and the average will be calculated for each assessment. Change will be calculated as the postoperative average minus the preoperative average and reported in millimeters. Positive values indicate increased tissue thickness. Its association with total irrigation fluid volume will also be evaluated.
Change in Neck Circumference
Neck circumference will be measured with a non-stretchable measuring tape at the marked cricoid cartilage level before anesthesia and after surgery before extubation. Change will be calculated as the postoperative measurement minus the preoperative measurement and reported in centimeters. Positive values indicate an increase in neck circumference.
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