Viewing Study NCT04001881



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Last Modification Date: 2024-10-26 @ 1:13 PM
Study NCT ID: NCT04001881
Status: COMPLETED
Last Update Posted: 2022-05-12
First Post: 2019-06-26

Brief Title: Echocardiography and Spinal Induced Hypotension
Sponsor: Attikon Hospital
Organization: Attikon Hospital

Study Overview

Official Title: The Role of Heart Echocardiography in the Prediction of Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function
Status: COMPLETED
Status Verified Date: 2022-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 21 cm with IVCCI 20 quite inspiration suggests normal RAP of 3mmHg range 0-5mmHg whereas IVC diameter 21 cm with IVCCI20 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
Detailed Description: Methods In the present prospective study consecutive sampling is been used to recruit elderly patients age70 years hospitalized in the Attikon University Hospital of Athens Patients is included if they sustain orthopaedic operation of the lower limb under spinal anaesthesia This study was approved for ethics and consent by the Institutional Review BoardEthics Committee of the authors institution

Patients medical history physical examination ECG and X-ray assessment are standard practice supplemented by specific exams or tests eg TTE or pro-BNP levels are performed per the consultant cardiologists recommendations All patients included in our study are American Heart AssociationAmerican College of CardiologyAHAACC 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 also patients with right ventricle RV dysfunction and severe valvular diseases are not included in the study

A standard intraoperative 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

All data are saved and stored digitally for off-line postoperative analysis The EF is determined using the biplane Simpsons method by performing automated measurements of LV volumes in 2CH and 4CH views GE Auto-EF system

The LV-EF stroke volume index SVI peripheral vascular resistance PVR LV filling pressures EEm ratio right ventricle RV function tricuspid annular plane systolic excursion TAPSE tricuspid annular systolic velocity TASV fractional area change FAC the IVCCI and dIVCmax-to-IVCCI ratio were assessed Stroke volume SV and subsequent stroke volume index SVISVm2 of the LV is assessed by using automated measurements of LV volumes according to the formula SV EDV-ESV where EDVend-diastolic LV volume and ESVend-systolic LV volume From these data we also derived values for the assessment of cardiac output CO SV x HR subsequent systemic vascular resistance SVR MAP x 80CO mean arterial blood pressureMAP HRheart rate

IVC measurements include its maximum diameter at the end of expiration dIVCmax IVCCI during spontaneous quiet breathing IVC maximal diameter - IVC minimal diameterIVC maximal diameter and the ratio R of dIVCmax-to-IVCCI the IVC diameters is measured in the long axis of the IVC and just proximal to the entry of the hepatic veins

Anesthetic protocol and measurements Spinal anesthesia is introduced with a single intrathecal injection of 12 to 18 mg average15 mg plain ropivacaine 075 solution using a 22 or 25-gauge needle pencil-point with the patient in the lateral position Intraoperative ECG SPO2 and invasive arterial blood pressure through an indwelling radial artery catheter monitoring is used Patients who are experiencing a MAP less than or equal to 65 mmHg or greater than or equal to 25 reduction of its baseline preoperative value were considered hypotensive duration of low MAP 30sec time-period from spinal anesthesia induction to the end of surgery Arterial hypotension related to blood transfusion for any reason is not considered in our statistical analysis

Data analysisA pilot study of 18 patients revealed a detected area under the ROC curve AUC of 089 for dIVCmax-to-IVCCI and for IVCCI 074 with rank correlation between the two assays being 088 in positive and 062 in negative cases Based on this result a sample of 40 patients will be required to achieve a power of 80 in order to detect significant difference at a level 005 between dIVCmax-to-IVCCI ratio and IVCCI MedCalc Software Mariakerke Belgium Quantitative variables and proportions are compared with the student t-test or Mann-Whitney and chi-square tests respectively Normality is tested by using the Kolmogorov- Smirnov test We will assess the area under the receiver operator characteristic curve AUC-ROC to evaluate the diagnostic performance of echocardiographic parameters in identifying patients who experience spinal-induced hypotension The grey zone estimation between two cut-off points will be used for clinical utility reasons

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None