Relationship Between Irrigation Fluid Volume, Endotracheal Tube Cuff Pressure, and Anterior Neck Soft Tissue Thickness in Shoulder Arthroscopy: A Prospective Observational Study
| Registry | NCT07852702 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 60 (Estimated) |
| Sponsor | Fatih Sultan Mehmet Training and Research Hospital (Other) |
| Conditions | Shoulder Arthroscopy, Endotracheal Tube Cuff Pressure, Neck Soft Tissue Edema |
| Interventions | Elective Shoulder Arthroscopy (Procedure) |
| Dates | start 2026-10-15 (estimated), primary completion 2027-03-01 (estimated), completion 2027-03-15 (estimated), first posted 2026-10-01, last updated 2026-10-01 |
| Locations | 1 site in Turkey (Türkiye) |
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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.
Shoulder arthroscopy requires pressurized irrigation to expand the glenohumeral joint and subacromial space and maintain adequate surgical visualization. A portion of the irrigation fluid may pass into the periarticular tissues and extend along anatomical planes toward the shoulder girdle, supraclavicular region, chest wall, and neck. This fluid movement may cause cervical soft tissue edema and potentially affect endotracheal tube cuff pressure. However, prospective data combining standardized serial cuff pressure measurements with ultrasonographic assessment of anterior neck soft tissue thickness are limited.
This single-center, prospective observational cohort study will include approximately 60 adults undergoing elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation. Participation in the study will not alter the surgical indication, anesthesia management, irrigation pump settings, or other clinical treatment. All clinical decisions will remain at the discretion of the responsible anesthesia and surgical teams.
After tracheal intubation, endotracheal tube cuff pressure will be measured with a calibrated manometer and adjusted to 25 cmH2O. Following placement in the beach-chair position, cuff pressure will be measured again after five minutes and readjusted to 25 cmH2O, which will serve as the standardized baseline. During surgery, cuff pressure will be recorded at 15, 30, 45, and 60 minutes after the start of irrigation and every 30 minutes thereafter while surgery continues. A final measurement will be obtained at the end of surgery while the participant remains in the beach-chair position. After each measurement, cuff pressure will be readjusted to 25 cmH2O to avoid prolonged exposure to elevated pressure. An additional measurement will be obtained five minutes after the participant is returned to the supine position.
The total volume of irrigation fluid, irrigation pump pressure, surgical duration, anesthesia duration, surgical procedure, intravenous crystalloid volume, estimated blood loss, and relevant airway and anesthesia variables will be recorded. The maximum increase in cuff pressure will be calculated as the highest measured intraoperative cuff pressure minus the standardized baseline pressure of 25 cmH2O.
Anterior neck soft tissue thickness will be measured before anesthesia and again before extubation with a high-frequency linear ultrasound probe. Measurements will be obtained at the level of the cricoid cartilage, from the skin to the anterior tracheal air-mucosa interface. Three measurements will be taken at each assessment, and their average will be used. Neck circumference will be measured at the same anatomical level before and after surgery.
Postoperative sore throat will be assessed using a 0-to-10 numerical rating scale, and hoarseness will be graded as absent, mild, moderate, or severe. Dysphagia, stridor, delayed extubation, and other airway-related events will also be recorded in the post-anesthesia care unit and at the postoperative sixth hour.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Shoulder Arthroscopy Cohort | Procedure: Elective Shoulder Arthroscopy | Adults aged 18 to 75 years with ASA physical status I-III who are undergoing elective shoulder arthroscopy in the beach-chair position under general anesthesia with orotracheal intubation. No intervention will be assigned by the study, and routine anesthesia, surgical management, and irrigation pump settings will not be changed. Total irrigation fluid volume, serial endotracheal tube cuff pressures, preoperative and postoperative anterior neck soft tissue thickness and neck circumference, and postoperative airway symptoms will be recorded. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * 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 Exclusion Criteria: * Emergency surgery * Pregnancy * Preoperative hoarseness, sore throat, or dysphagia * Upper respiratory tract infection within the previous 2 weeks * Tracheostomy, known laryngeal or tracheal disease, or previous major neck surgery or radiotherapy * Anticipated difficult airway, defined as Mallampati class III-IV or difficult airway predicted by the attending anesthesiologist * More than two tracheal intubation attempts or traumatic intubation * Surgery performed in the lateral decubitus position * Intraoperative use of nitrous oxide * Inability to obtain reliable ultrasonographic measurements
| Facility | City | Country | Status |
|---|---|---|---|
| University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research | Istanbul | Turkey (Türkiye) |