Echocardiography and Spinal Induced Hypotension.

NCT04001881 | Completed DMC

• 1 other identifier: 3332017
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Modern guidelines have combined both the maximum diameter of IVC at expiration (dIVC max) and the IVCCI to appreciate right atrial pressure (RAP) measurements and consequently to assess intravascular volume status. In fact, IVC diameter \<2.1 cm with IVCCI \>20% (quite inspiration) suggests normal RAP of 3mmHg (range, 0-5mmHg), whereas IVC diameter \>2.1 cm with IVCCI\<20% suggests high RAP of 15mmHg (range, 10-20mmHg). In occasions where the IVC diameter and collapse is not fit the above categories, an intermediate value of 8 mmHg (range, 5-10 mmHg) is applied. From a clinical standpoint, it is conceivable that both measurements must be measured in isolation to enable RAP assessment. To circumvent this limitation the two indices have been consolidated to dIVCmax-to-IVCCI ratio. Although this ratio has been shown high accuracy to predict spinal-induced hypotension in elderly patients with preserved ejection fraction (EF) of the left ventricle (LV), its value in patients with cardiac dysfunction and reduced LV-EF has not been investigated. From the aforementioned, this study sets out to address the role of dIVCmax-to-IVCCI ratio in the prediction as well as in the management of hypotension after spinal anesthesia in elderly orthopaedic patients with reduced LV-EF.

Conditions

Spinal Anesthetic Toxicity

Keywords

inferior vena cava; spinal anesthesia; echocardiography

Outcome Measures

Primary Outcomes (1)

• Predictive value of dIVCmax-to-IVCCI ratio

  Preoperative performance of the dIVCmax-to-IVCCI ratio The main outcome will be the preoperative performance of the dIVCmax-to-IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in patients with low LV-EF

  18 months

Study Arms (2)

Hypotension group

spinal anesthesia in Hypotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia

Other: Transthoracic echocardiography; Drug: Spinal anesthesia

Normotension group

spinal anesthesia IN Normotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia

Other: Transthoracic echocardiography; Drug: Spinal anesthesia

Interventions

Transthoracic echocardiography OTHER

A standard TTE protocol is used in all patients and included the following views: subcostal 4-chamber (SUBC), apical 4-chamber (4CH), apical 2-chamber (2CH), apical 3-chamber (3CH), parasternal long (LAX) and short axis (SAX).

Also known as: TTE

Hypotension group; Normotension group

Spinal anesthesia DRUG

Spinal anesthesia is introduced with a single intrathecal injection of 12 to 18 mg (15 mg average dose) plain ropivacaine (0.75% solution) using a 22 or 25-gauge needle (pencil-point) with the patient in the lateral position.

Also known as: Neuraxial block

Hypotension group; Normotension group

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients is included if they sustain orthopaedic operation of the lower limb under spinal anaesthesia. Patients' medical history, physical examination, ECG, and X-ray assessment are standard practice, supplemented by specific exams or tests (e.g. TTE or pro-BNP levels), are performed per the consultant cardiologist's recommendations. All patients included in our study were American Heart Association/American College of Cardiology(AHA/ACC) stage II or III with ejection fraction (EF) of the left ventricle (LV) between 35 and 50%, and their cardiac disease status always in compensated status

You may qualify if:

• Orthopaedic trauma patients Reduced LV-EF (35% \<EF\<50%) Elderly patients

You may not qualify if:

• Patients with right ventricle (RV) dysfunction/patients with LV-EF\<35%/
• Severe pulmonary hypertension
• Tachycardia (heart rate \> 100 beats/min), atrial fibrillation.
• Patients with tricuspid and mitral regurgitation more than grade 2 and those with more than moderate valvular stenosis were excluded.
• Left ventricular dysynchrony
• TAPSE index\<16 and/orTDI-tricuspid annulus\<10 cm/sec and/or Fractional Area Shortening\<35.
• Spinal block below T-12 level Overt intraoperative haemorhage

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS

Athens, Attica, 15562, 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

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• THEODOSIOS SARANTEAS, PROFESSOR

  MEDICAL SCHOOL OF ATHENS, GREECE, EU

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: August 1, 2019
• Primary Completion: April 25, 2022
• Study Completion: May 5, 2022
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)