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

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: Arthroscopic Shoulder Surgery
• Intervention / Treatment: Procedure: vena cava inferior diameter measurement

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

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 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

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	Head of bed at 0 degrees flat and both legs elevated to 45 degrees	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.	2 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital

Study record dates

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: passive leg raising maneuver, vena cava inferior diameter
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No