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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04152135
Other study ID # 1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 29, 2019
Est. completion date September 1, 2020

Study information

Verified date November 2019
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
vena cava inferior diameter measurement
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary passive leg raising maneuver Head of bed at 0 degrees flat and both legs elevated to 45 degrees 2 minutes
Primary 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 Blood pressure non-invasive measurement, routine monitoring 2 minutes
Secondary Heart rate Routine monitoring 2 minutes
Secondary End-tidal CO2 Routine monitoring after intubation 2 minutes
Secondary plethysmographic waveform Routine monitoring 2 minutes
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