Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension

NCT03266250 | Completed DMC

• 1 other identifier: ED399,09-24-2015
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Study Protocol: Outcome Measurements Primary Outcome The main outcome will be the preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in a greater extent to that of the established IVCCI measurements. Secondary Outcomes To identify other echocardiographic or clinical measurements that can predict an intraoperative spinal-induced haemodynamic instability. Sample Size Calculation A pilot study of 20 patients revealed a detected area under the ROC curve (AUC) of 0,91 for dIVCmax/IVCCI and for dIVCmax 0,82 with rank correlation between the two assays being 0.87 in both positive and negative cases. Based on this result, a sample of 56 patients will achieve 80% power to detect significant difference (at a level 0.05) between dIVCmax/IVCCI and dIVCmax. Potential Benefits of the Study The results of this study will allow us to determine which clinical or US-measurement can yield better performance so as a preoperative prediction of spinal-induced hypotension can be achieved; that way these measurements can permit and guide a targeted preoperative fluid challenges prior to the implementation of spinal anesthesia Potential Side Effects of the Study Participation in this protocol will not put patients at higher risk for complications since we do not perform any intervention (either pharmacological or surgical) There will be no occupational risks to researchers or assistants. Proposed Timetable According to the exclusion criteria and taking into account the number of cases performed in our department per monthly basis, it should take us approximately 6 months to recruit 60 patients.

Conditions

Spinal Anesthetic Toxicity; Inferior Vena Cava Abnormality; Intraoperative Complications

Keywords

inferior vena caca ultrasound

Outcome Measures

Primary Outcomes (1)

• Preoperative performance of the dIVCmax/IVCCI ratio

  The main outcome will be the preoperative performance of the dIVCmax/IVCCI ratio to foresee the incidence of hypotension after spinal anesthesia in a greater extent to that of the established IVCCI measurements

  6 months

Secondary Outcomes (1)

• Echocardiographic or clinical measurements

  6 months

Study Arms (2)

spinal anesthesia Hypotensive patients

Transthoracic echocardiography of IVC before spinal anaesthesia

Procedure: spinal anesthesia

spinal anesthesia Normotensive patients

Transthoracic echocardiography of IVC before spinal anaesthesia

Procedure: spinal anesthesia

Interventions

spinal anesthesia PROCEDURE

Transthoracic echocardiography of inferior vena cava before spinal anesthesia

spinal anesthesia Hypotensive patients; spinal anesthesia Normotensive patients

Eligibility Criteria

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

Study Population

Elderly orthopaedic patients

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

ATTIKON University General Hospital

Athens, Attica, 15562, Greece

Location

Related Publications (1)

• Zhang J, Critchley LA. Inferior Vena Cava Ultrasonography before General Anesthesia Can Predict Hypotension after Induction. Anesthesiology. 2016 Mar;124(3):580-9. doi: 10.1097/ALN.0000000000001002.

  PMID: 26771910 BACKGROUND

MeSH Terms

Conditions

Intraoperative Complications

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Theodosis Saranteas, MD

  National and Kapodistrian University of Athens, School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: August 15, 2017
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: August 21, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)