Hemodynamic Changes With Passive Leg Raising Maneuver in Patients Undergoing Arthroscopic Shoulder Surgery

November 2, 2019 updated by: merve namlı emlek, Diskapi Teaching and Research Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ASA 1-2 status patients between the ages of 18-65 to be performed arthroscopic shoulder surgery with informed consent

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient refusal,
  • Patients with current heart and valve disease,
  • Patients with ASA 3-4 status,
  • Emergency cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
passive leg raising maneuver
Time Frame: 2 minutes
Head of bed at 0 degrees flat and both legs elevated to 45 degrees
2 minutes
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.
2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 2 minutes
non-invasive measurement, routine monitoring
2 minutes
Heart rate
Time Frame: 2 minutes
Routine monitoring
2 minutes
End-tidal CO2
Time Frame: 2 minutes
Routine monitoring after intubation
2 minutes
plethysmographic waveform
Time Frame: 2 minutes
Routine monitoring
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 29, 2019

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

November 2, 2019

First Submitted That Met QC Criteria

November 2, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 2, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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