NCT04152135

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

November 29, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

November 2, 2019

Last Update Submit

November 2, 2019

Conditions

Keywords

passive leg raising maneuver, vena cava inferior diameter

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Blood pressure

    2 minutes

  • Heart rate

    2 minutes

  • End-tidal CO2

    2 minutes

  • plethysmographic waveform

    2 minutes

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • years old patients,
  • The American Society of Anesthesiologists (ASA) physical status classification score 1-2,
  • Patients scheduled for arthroscopic shoulder surgery, intubated, sitting position

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 5, 2019

Study Start

November 29, 2019

Primary Completion

August 31, 2020

Study Completion

September 1, 2020

Last Updated

November 5, 2019

Record last verified: 2019-11