Shoulder ArthroscopyNCT07572539
The Accuracy of Peripheral Perfusion Index and Inferior Vena Cava Collapsibility Index for Predicting Hypotension in Patients Undergoing Shoulder Arthroscopy in Beach Chair Position:
An observational study of Shoulder Arthroscopy and Peripheral Perfusion Index, run by Tanta University at 1 site in Egypt.
Trial summary
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Shoulder Arthroscopy, Peripheral Perfusion Index, Inferior Vena Cava Collapsibility Index
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2025to 30 Oct 2026
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 adult patients of both sexes (aged 21- 65 years) with American Society of Anesthesiologists (ASA) physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia.
Who may be able to join
- Adult patients of both sexes (aged 21- 65 years)
- patients with American Society of Anesthesiologists physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia.
Who cannot join
- Patient's refusal
- Patients with suspected difficult airway
- Patients with preexisting hypertension, diabetes mellitus, cardiovascular, cerebrovascular and peripheral vascular diseases
- Patients with preoperative hypotension (mean arterial blood pressure < 65 mmHg).
- Patients with preexisting renal or hepatic impairment.
- Pregnancy 8. Patients with increased intra-abdominal pressure 9. Patients with post induction hypotension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Accuracy of Peripheral Perfusion Index and Inferior Vena Cava Collapsibility Index for Predicting Hypotension in Patients Undergoing Shoulder Arthroscopy in Beach Chair Position: A Prospective Observational Study
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in perioperative hemodynamic management.
Primary outcome The accuracy of Peripheral Perfusion Index for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position Secondary outcomes
- Incidence of hypotension.
- Amount of administered fluids and total dose of vasopressors.
- The diagnostic accuracy of inferior vena cava collapsibility index in predicting hypotension.
Read the detailed description
Shoulder arthroscopy is a minimally invasive surgical procedure widely utilized for the diagnosis and treatment of various shoulder joint pathologies, it is commonly performed with patients positioned in the beach chair position , which enhances access to the shoulder joint.
In the beach chair position, the patient is placed in in a semi-sitting position with an angle ranging from 30-60 degrees, depending on surgeon preference and procedure requirements. The lower extremities are typically slightly flexed. Patient's head is securely supported using a specialized head rest or padding while the operative arm draped freely or positioned using a mechanical arm holder for optimal access to the shoulder joint.
Nonetheless, the beach chair position has unique physiological challenges including reduced venous return, decreased cardiac output which eventually results in an increased risk of hypotension. Hypotension during surgery can compromise organ perfusion, potentially leading to cerebral ischemia, myocardial dysfunction, and delayed recovery, thus blood pressure monitoring across the procedure is crucial for optimizing patient safety, outcomes and to prevent potential complications.
Various parameters have been implemented to predict hypotension in beach chair position including; pre-induction values of mean arterial pressure , stroke volume variation , cardiac index and stroke volume index but the inconsistent sensitivity and specificity, together with the necessity for invasive monitoring, may limit their routine use.
Ultrasound measurement of the inferior vena cava collapsibility index and inferior vena cava diameter has the advantages of easy performance, repeatability and low cost and has often been used to predict fluid responsiveness in emergency and critical care settings. Recently, this noninvasive hemodynamic assessment method was introduced to predict post induction hypotension in the operating room . However, its utility remains controversial across different population settings and different types of anaesthesia.
Peripheral Perfusion Index is a non-invasive measure of peripheral perfusion. It is derived from the ratio of pulsatile to non-pulsatile blood flow as measured by photoplethysmography, it measures the central hemodynamics reflecting both vascular tone and cardiac output in patients undergoing general anesthesia, and a correlation between low PPI and low blood volume has been reported. As an emerging clinical tool it helps in early detection of hemodynamic instability.
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in perioperative hemodynamic management.
Primary outcome The accuracy of Peripheral Perfusion Index for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position
- Conditions
- Shoulder Arthroscopy, Peripheral Perfusion Index, Inferior Vena Cava Collapsibility Index, Hypotension
- Keywords
- Inferior Vena Cava Collapsibility Index, Peripheral Perfusion Index, Beach Chair Position, Shoulder Arthroscopy
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | 70 adult patients of both sexes (aged 21- 65 years) with American Society of Anesthesiologists physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of Peripheral Perfusion Index for predicting hypotension
The Peripheral Perfusion Index will be measured using a pulse oximetry probe attached to the index finger of the non-operable hand
Measured: pre induction of General anesthesia
Secondary outcomes (1)
Incidence of hypotension
Measured: 30 minutes Intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start30 May 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ellithy Ahmed Barakat, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572539
- Sponsor's protocol ID
- 36264MS884/3/25
- Status last verified
- May 2025
- First submitted
- 30 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be available if it needed
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Peripheral Perfusion Index and Inferior Vena Cava Collapsibility Index for Predicting Hypotension in Patients Undergoing Shoulder Arthroscopy in Beach Chair Position: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07572539
- Acronym / sponsor ID
- 36264MS884/3/25
- Conditions
- Shoulder Arthroscopy, Peripheral Perfusion Index, Inferior Vena Cava Collapsibility Index, Hypotension
- Keywords
- Inferior Vena Cava Collapsibility Index, Peripheral Perfusion Index, Beach Chair Position, Shoulder Arthroscopy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 7 May 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.
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in perioperative hemodynamic management.
Primary outcome The accuracy of Peripheral Perfusion Index for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position Secondary outcomes
- Incidence of hypotension.
- Amount of administered fluids and total dose of vasopressors.
- The diagnostic accuracy of inferior vena cava collapsibility index in predicting hypotension.
Detailed description
Shoulder arthroscopy is a minimally invasive surgical procedure widely utilized for the diagnosis and treatment of various shoulder joint pathologies, it is commonly performed with patients positioned in the beach chair position , which enhances access to the shoulder joint.
In the beach chair position, the patient is placed in in a semi-sitting position with an angle ranging from 30-60 degrees, depending on surgeon preference and procedure requirements. The lower extremities are typically slightly flexed. Patient's head is securely supported using a specialized head rest or padding while the operative arm draped freely or positioned using a mechanical arm holder for optimal access to the shoulder joint.
Nonetheless, the beach chair position has unique physiological challenges including reduced venous return, decreased cardiac output which eventually results in an increased risk of hypotension. Hypotension during surgery can compromise organ perfusion, potentially leading to cerebral ischemia, myocardial dysfunction, and delayed recovery, thus blood pressure monitoring across the procedure is crucial for optimizing patient safety, outcomes and to prevent potential complications.
Various parameters have been implemented to predict hypotension in beach chair position including; pre-induction values of mean arterial pressure , stroke volume variation , cardiac index and stroke volume index but the inconsistent sensitivity and specificity, together with the necessity for invasive monitoring, may limit their routine use.
Ultrasound measurement of the inferior vena cava collapsibility index and inferior vena cava diameter has the advantages of easy performance, repeatability and low cost and has often been used to predict fluid responsiveness in emergency and critical care settings. Recently, this noninvasive hemodynamic assessment method was introduced to predict post induction hypotension in the operating room . However, its utility remains controversial across different population settings and different types of anaesthesia.
Peripheral Perfusion Index is a non-invasive measure of peripheral perfusion. It is derived from the ratio of pulsatile to non-pulsatile blood flow as measured by photoplethysmography, it measures the central hemodynamics reflecting both vascular tone and cardiac output in patients undergoing general anesthesia, and a correlation between low PPI and low blood volume has been reported. As an emerging clinical tool it helps in early detection of hemodynamic instability.
This study will assess the accuracy of Peripheral Perfusion Index and inferior vena cava collapsibility index as predictive tools for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position under general anesthesia, contributing to the broader understanding of its role in perioperative hemodynamic management.
Primary outcome The accuracy of Peripheral Perfusion Index for predicting hypotension in patients undergoing shoulder arthroscopy in the beach chair position
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –70 adult patients of both sexes (aged 21- 65 years) with American Society of Anesthesiologists physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 adult patients of both sexes (aged 21- 65 years) with American Society of Anesthesiologists (ASA) physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia.
Key inclusion criteria (2 listed)
- Adult patients of both sexes (aged 21- 65 years)
- patients with American Society of Anesthesiologists physical status I or II scheduled for elective shoulder arthroscopy in beach chair position under general anesthesia.
Key exclusion criteria (6 listed)
- Patient's refusal
- Patients with suspected difficult airway
- Patients with preexisting hypertension, diabetes mellitus, cardiovascular, cerebrovascular and peripheral vascular diseases
- Patients with preoperative hypotension (mean arterial blood pressure < 65 mmHg).
- Patients with preexisting renal or hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of Peripheral Perfusion Index for predicting hypotension
Time frame: pre induction of General anesthesia
The Peripheral Perfusion Index will be measured using a pulse oximetry probe attached to the index finger of the non-operable hand
1 secondary outcome
Incidence of hypotension
Time frame: 30 minutes Intraoperatively
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 7 May 2026.
- Individual participant dataSharing planned: Yes. It will be available if it needed
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Peripheral Perfusion Index, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 7 May 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of Peripheral Perfusion Index for predicting hypotension (time frame: pre induction of General anesthesia). 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 7 May 2026.