Shoulder ArthroscopyNCT07852702
Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy
An observational study of Shoulder Arthroscopy and Endotracheal Tube Cuff Pressure, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Arthroscopy, Endotracheal Tube Cuff Pressure, Neck Soft Tissue Edema
- What is being tested?
- Elective Shoulder Arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 15 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences Fatih Sultan Mehmet Training and Research Hospital Scientific Research
Istanbul, 34000
Cansu Ofluoglu, MD, +905358640564, cansuakin.iu@gmail.com
About this study
Official title: Relationship Between Irrigation Fluid Volume, Endotracheal Tube Cuff Pressure, and Anterior Neck Soft Tissue Thickness in Shoulder Arthroscopy: A Prospective Observational Study
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.
Read the detailed description
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.
- Being tested
- Elective Shoulder Arthroscopy
- 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
- Medical subject headings
- Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective Shoulder ArthroscopyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Elective Shoulder Arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours
Secondary outcomes (7)
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.
Measured: 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
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.
Measured: From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours
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.
Measured: From the preoperative assessment before anesthesia induction to the postoperative assessment before extubation, approximately 1 to 3 hours
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.
Measured: 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
Surgical duration will be recorded in minutes, and the maximum increase in endotracheal tube cuff pressure will be calculated as the highest intraoperative cuff pressure minus the standardized baseline of 25 cmH2O. The association between surgical duration and maximum cuff pressure increase will be evaluated using a Pearson or Spearman correlation coefficient, depending on data distribution.
Measured: During surgery, approximately 1 to 3 hours
Postoperative Sore Throat Intensity
Sore throat intensity will be assessed using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no sore throat and 10 indicates the worst possible sore throat. Assessments will be performed at admission to the post-anesthesia care unit and at the postoperative sixth hour. The association between sore throat scores and maximum cuff pressure increase will also be evaluated.
Measured: At post-anesthesia care unit admission and 6 hours after surgery
Postoperative Hoarseness Severity
Hoarseness will be assessed and categorized as absent, mild, moderate, or severe at admission to the post-anesthesia care unit and at the postoperative sixth hour. The number and percentage of participants in each category will be reported. The association between hoarseness severity and maximum cuff pressure increase will also be evaluated.
Measured: At post-anesthesia care unit admission and 6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doğa Meriç Yükselen, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852702
- Sponsor's protocol ID
- FSMTRH-SHOULDER-CP-2026
- Other IDs
- 2026/07-74
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Irrigation Fluid Volume, Endotracheal Tube Cuff Pressure, and Anterior Neck Soft Tissue Thickness in Shoulder Arthroscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07852702
- Acronym / sponsor ID
- FSMTRH-SHOULDER-CP-2026
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Arthroscopy Cohort | – | Procedure: Elective Shoulder ArthroscopyAdults 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective Shoulder ArthroscopyParticipants 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. | Procedure or surgery | Shoulder Arthroscopy Cohort |
Primary outcome
Maximum Increase in Endotracheal Tube Cuff Pressure (ΔPmax)
Time frame: From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours
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.
7 secondary outcomes
Maximum Endotracheal Tube Cuff Pressure
Time frame: 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
Time frame: From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours
Change in Anterior Neck Soft Tissue Thickness
Time frame: From the preoperative assessment before anesthesia induction to the postoperative assessment before extubation, approximately 1 to 3 hours
Change in Neck Circumference
Time frame: 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
Time frame: During surgery, approximately 1 to 3 hours
Postoperative Sore Throat Intensity
Time frame: At post-anesthesia care unit admission and 6 hours after surgery
Postoperative Hoarseness Severity
Time frame: At post-anesthesia care unit admission and 6 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroscopy and Endotracheal Tube Cuff Pressure, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doğa Meriç Yükselen, MD (+905362963155, d.m.boybeyi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Increase in Endotracheal Tube Cuff Pressure (ΔPmax) (time frame: From 5 minutes after beach-chair positioning until completion of surgery, approximately 1 to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.