Internal Jugular Vein and Spinal-induced Hypotension

NCT05015218 | Completed

• 1 other identifier: ID: EBΔ 630 (23/11/2021)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The study aims to assess internal jugular vein ultrasound derived measurements and indices prior to spinal anesthesia in elderly population who fulfills predetermined inclusion criteria and might greatly benefit from an appropriate hemodynamic control during orthopedic surgery. Therefore, it is evaluated the diagnostic performance of these indices in predicting spinal-induced hypotension in this subset of participants.

Conditions

Haemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Internal jugular vein aerea (cm2) prior to spinal anesthesia implementation

  Using GE-T8 Ultrasound System device, the right and leftinternal jugular vein is visualized on the short axis with a 5-10 MHz linear probe in B-mode.

  10 minutes prior to spinal anesthesia

Interventions

Vacular Ultrasound DIAGNOSTIC_TEST

To visualize the internal jugular veins ( IJVs) a linear transducer with a 5-10 MHz linear probe was placed over the neck, and the IJV was measured just below the bifurcation of the sternal and clavicular heads of the muscle. The IJV measurements were performed on the transverse axis over a single respiratory cycle. Patients with evidence of IJV thrombosis were excluded. IJV measurements included the antero-posterior maximum diameter at the end of expiration (IJVmax), the antero-posterior mimimum diameter/area at the end of inspiration (IJVmin), the IJV collapsibility index (IJV-CI) during spontaneous, quiet, breathing, \[(IJVmax - IJVmin area)/IJVmax\] and the ratio (R) of IJVmax-to-IJV-CI.

Also known as: Blood pressure recordings

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive sampling is used to recruit dehydrated aging patients (\>70 years), who sustain trauma of the lower limb and underwent an orthopedic surgical procedure under spinal anesthesia. Patients' medical history, blood tests, physical examination, ECG, and X-ray assessment are standard practice, supplemented by specific exams or tests (e.g. TTE or pro-BNP levels), were performed per the consultant cardiologist's recommendations. All patients in our study were American Heart Association/American College of Cardiology (ACC) stage I, II and their cardiac disease is in a compensated status;

You may qualify if:

• Dehydrated elderly patients with orthopaedic trauma of the lower limb,
• American Heart Association/American College of Cardiology (ACC) stage I or II.
• Cardiac disease is in a compensated status.

You may not qualify if:

• Atria fibrilation/Tachycardia (heart rate \> 100 beats/min)
• Sensory block less than T12
• Overt intraoperative bleeding
• Severe pulmonary hypertensopn/tricuspid regurgitation

Sponsors & Collaborators

• Attikon Hospital: lead
• Ohio State University: collaborator

Study Sites (2)

Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS

Athens, Attica, 15562, Greece

Location

Theodosios Saranteas

Athens, Gerakas, 15344, Greece

Location

Related Publications (1)

• Saranteas T, Spiliotaki H, Koliantzaki I, Koutsomanolis D, Kopanaki E, Papadimos T, Kostopanagiotou G. The Utility of Echocardiography for the Prediction of Spinal-Induced Hypotension in Elderly Patients: Inferior Vena Cava Assessment Is a Key Player. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2421-2427. doi: 10.1053/j.jvca.2019.02.032. Epub 2019 Feb 22.

  PMID: 30904260 RESULT

Study Officials

• HEODOSIOS SARANTEAS, PROFESSOR

  MEDICAL SCHOOL UNIVERSITY OF ATHENS, NKUA, GREECE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 20, 2021
• Study Start: November 23, 2021
• Primary Completion: October 27, 2024
• Study Completion: October 27, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2)