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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFatih Sultan Mehmet Training and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Elective Shoulder Arthroscopy

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Shoulder Arthroscopy Cohort1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours
2

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.

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

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.

Time frame
From the preoperative assessment before anesthesia induction to the postoperative assessment before extubation, approximately 1 to 3 hours
4

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.

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

Other outcomes

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