Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy

NCT07852702 | Not Yet Recruiting

• 2 other identifiers: FSMTRH-SHOULDER-CP-20262026/07-74
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Arthroscopy; Endotracheal Tube Cuff Pressure; Neck Soft Tissue Edema

Keywords

irrigation fluid volume; fluid extravasation; endotracheal tube cuff pressure; anterior neck soft tissue thickness; neck ultrasonography; beach-chair position; cervical soft tissue edema; postoperative sore throat; hoarseness

Outcome Measures

Primary Outcomes (1)

• 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.

  From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours

Secondary Outcomes (7)

• Maximum Endotracheal Tube Cuff Pressure

  From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours

• Occurrence of Endotracheal Tube Cuff Pressure Above 30 cmH2O

  From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours

• Change in Anterior Neck Soft Tissue Thickness

  From the preoperative assessment before anesthesia induction to the postoperative assessment before extubation, approximately 1 to 3 hours

• Change in Neck Circumference

  From the preoperative assessment before anesthesia induction to the postoperative assessment before extubation, approximately 1 to 3 hours

• Association Between Surgical Duration and Maximum Cuff Pressure Increase

  During surgery, approximately 1 to 3 hours

Study Arms (1)

Shoulder Arthroscopy Cohort

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.

Procedure: Elective Shoulder Arthroscopy

Interventions

Elective Shoulder Arthroscopy PROCEDURE

Participants 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.

Shoulder Arthroscopy Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hoarseness

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Central Study Contacts

Doğa Meriç Yükselen, MD

CONTACT

+905362963155; d.m.boybeyi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Specialist

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Locations

TU (1)