Arthroscopic Shoulder SurgeryNCT04152135
Hemodynamic Changes With Passive Leg Raising Maneuver in Patients Undergoing Arthroscopic Shoulder Surgery
An observational study of Arthroscopic Shoulder Surgery, run by Diskapi Teaching and Research Hospital.
Trial summary
After intubation of the patients who are undergoing arthroscopic shoulder surgery, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and inferior vena cava (IVC) diameter will be measured by ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroscopic Shoulder Surgery
- What is being tested?
- vena cava inferior diameter measurement
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ASA 1-2 status patients between the ages of 18-65 to be performed arthroscopic shoulder surgery with informed consent
Who may be able to join
- 18-65 years old patients,
- The American Society of Anesthesiologists (ASA) physical status classification score 1-2,
- Patients scheduled for arthroscopic shoulder surgery, intubated, sitting position
Who cannot join
- Patient refusal,
- Patients with current heart and valve disease,
- Patients with ASA 3-4 status,
- Emergency cases
About this study
Official title: Evaluation of Volume Status by Passive Leg Removal Maneuver and Vena Cava Inferior Diameter Measurements Before the Position of Patients in Arthroscopic Shoulder Surgery
After intubation of the patients who are undergoing arthroscopic shoulder surgery, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and inferior vena cava (IVC) diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.
Read the detailed description
Patients aged between 18-65 years who are undergoing arthroscopic shoulder surgery will be examined. After giving detailed information, voluntary certificate will be taken from patients who accept to participate in the study. Heart rate, oxygen saturation and blood pressure values will be recorded by routine monitoring. After intubation of the patients, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and IVC diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.
- Conditions
- Arthroscopic Shoulder Surgery
- Being tested
- vena cava inferior diameter measurement
- Keywords
- passive leg raising maneuver, vena cava inferior diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vena cava inferior diameter measurementProcedure or surgery
Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement.
What is being measured
The primary outcome is the main question the study is designed to answer.
passive leg raising maneuver
Head of bed at 0 degrees flat and both legs elevated to 45 degrees
Measured: 2 minutes
vena cava inferior diameter
Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement.
Measured: 2 minutes
Secondary outcomes (4)
Blood pressure
non-invasive measurement, routine monitoring
Measured: 2 minutes
Heart rate
Routine monitoring
Measured: 2 minutes
End-tidal CO2
Routine monitoring after intubation
Measured: 2 minutes
plethysmographic waveform
Routine monitoring
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start29 Nov 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, merve namlı emlek, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152135
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2019
- First submitted
- 2 Nov 2019
- Last updated
- 5 Nov 2019
- 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 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Volume Status by Passive Leg Removal Maneuver and Vena Cava Inferior Diameter Measurements Before the Position of Patients in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT04152135
- Acronym / sponsor ID
- 1
- Conditions
- Arthroscopic Shoulder Surgery
- Keywords
- passive leg raising maneuver, vena cava inferior diameter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 29 Nov 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 5 Nov 2019 (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.
After intubation of the patients who are undergoing arthroscopic shoulder surgery, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and inferior vena cava (IVC) diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.
Detailed description
Patients aged between 18-65 years who are undergoing arthroscopic shoulder surgery will be examined. After giving detailed information, voluntary certificate will be taken from patients who accept to participate in the study. Heart rate, oxygen saturation and blood pressure values will be recorded by routine monitoring. After intubation of the patients, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and IVC diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-2 status patients between the ages of 18-65 to be performed arthroscopic shoulder surgery with informed consent
Key inclusion criteria (3 listed)
- 18-65 years old patients,
- The American Society of Anesthesiologists (ASA) physical status classification score 1-2,
- Patients scheduled for arthroscopic shoulder surgery, intubated, sitting position
Key exclusion criteria (4 listed)
- Patient refusal,
- Patients with current heart and valve disease,
- Patients with ASA 3-4 status,
- Emergency cases
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 |
|---|---|---|
| vena cava inferior diameter measurementUltrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement. | Procedure or surgery | – |
Primary outcome
passive leg raising maneuver
Time frame: 2 minutes
Head of bed at 0 degrees flat and both legs elevated to 45 degrees
vena cava inferior diameter
Time frame: 2 minutes
Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement.
4 secondary outcomes
Blood pressure
Time frame: 2 minutes
Heart rate
Time frame: 2 minutes
End-tidal CO2
Time frame: 2 minutes
plethysmographic waveform
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroscopic Shoulder Surgery, run by Diskapi Teaching and Research Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
passive leg raising maneuver (time frame: 2 minutes). The study lists 2 primary outcomes in all. 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 5 Nov 2019.