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出境医 / 临床实验 / Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function and Echocardiography.

Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function and Echocardiography.

Study Description
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.


Condition or disease Intervention/treatment
Spinal Anesthetic Toxicity Other: Transthoracic echocardiography Drug: Spinal anesthesia

Show Show detailed description
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Transthoracic Echocardiography of Inferior Vena Cava Can Predict Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : November 1, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
Hypotension group
spinal anesthesia in Hypotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia
Other: Transthoracic echocardiography
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).
Other Name: TTE

Drug: Spinal anesthesia
Spinal anesthesia is introduced with a single intrathecal injection of 15 mg plain ropivacaine (0.75% solution) using a 22 or 25-gauge needle (pencil-point) with the patient in the lateral position.
Other Name: Neuraxial block

Normotension group
spinal anesthesia IN Normotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia
Other: Transthoracic echocardiography
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).
Other Name: TTE

Drug: Spinal anesthesia
Spinal anesthesia is introduced with a single intrathecal injection of 15 mg plain ropivacaine (0.75% solution) using a 22 or 25-gauge needle (pencil-point) with the patient in the lateral position.
Other Name: Neuraxial block

Outcome Measures
Primary Outcome Measures :
  1. Predictive value of dIVCmax-to-IVCCI ratio [ Time Frame: 16 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   70 Years to 100 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 30 and 50%, and their cardiac disease status always in compensated status

Criteria

Inclusion Criteria:

Orthopaedic trauma patients Reduced LV-EF (30% <EF<50%)

Exclusion Criteria:

  • patients with right ventricle (RV) dysfunction/ severe valvular diseases/patients with LV-EF<30%
Contacts and Locations

Contacts
Layout table for location contacts
Contact: THEODOSIOS SARANTEAS, Professor 00306973928195 thsaranteas@gmail.com
Contact: Georgia Kostopanagiotou, Professor 00302105832371 stheodosios@gmail.com

Locations
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Greece
Department of anesthesia ,ATTIKON UNIVERSITY HOSPITAL OF ATHENS Recruiting
Athens, Attica, Greece, 15562
Contact: THEODOSIOS SARANTEAS    00306973928195    thsaranteas@gmail.com   
Sponsors and Collaborators
Attikon Hospital
Investigators
Layout table for investigator information
Principal Investigator: THEODOSIOS SARANTEAS, PROFESSOR MEDICAL SCHOOL OF ATHENS, GREECE, EU
Tracking Information
First Submitted Date June 26, 2019
First Posted Date June 28, 2019
Last Update Posted Date December 8, 2020
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2019)
Predictive value of dIVCmax-to-IVCCI ratio [ Time Frame: 16 months ]
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function and Echocardiography.
Official Title Transthoracic Echocardiography of Inferior Vena Cava Can Predict Spinal-induced Hypotension in Elderly Patients With Reduced Left Ventricular Function.
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.

Detailed Description

Methods In the present prospective study, consecutive sampling is been used to recruit elderly patients (age>70 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 Board/Ethics Committee of the authors' institution.

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 are American Heart Association/American College of Cardiology(AHA/ACC) stage II or III with ejection fraction (EF) of the left ventricle (LV) between 30 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 Simpson's method, by performing automated measurements of LV volumes in 2CH and 4CH views (GE, Auto-EF system).

The tricuspid annular plane systolic excursion (TAPSE) index is used for the assessment of right ventricular function. Patients with right heart dysfunction (TAPSE<16 mm) are excluded from further analysis. Stroke volume (SV) and subsequent stroke volume index (SVI=SV/m2) of the LV is assessed by using automated measurements of LV volumes, according to the formula: SV= EDV-ESV, where EDV=end-diastolic LV volume and ESV=end-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 80/CO), (mean arterial blood pressure=MAP, HR=heart rate) and arterial elastance (EA = (SBP × 0.9)/SV).

IVC measurements included its maximum diameter at the end of expiration (dIVCmax), IVCCI during spontaneous, quiet, breathing, [(IVC maximal diameter - IVC minimal diameter)/IVC 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 15 mg plain ropivacaine (0.75% 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 bone cement application, tourniquet deflation, overt intraoperative/postoperative bleeding (blood loss>150cc) or patients receiving blood transfusion for any reason is not considered in our statistical analysis.

Data analysis: Quantitative variables and proportions are compared with the student t-test and chi-square test respectively. Normality is tested by using the Kolmogorov-Smirnov test. ROC curve analysis is performed to evaluate the diagnostic performance of echocardiographic parameters in identifying patients who experienced spinal-induced hypotension. The area under the curve (AUC) and the respective 95% confidence interval (95% CI) is estimated according to Hanley and McNeil.14 AUC curves is compared using the method described by DeLong et al.15 The results is expressed as percentage (%) or mean ± SD (standard deviation); a p value of <0.05 was considered statistically significant. Statistical analysis was performed using statistical analysis software (SPSS, 17.0, Chicago, IL; MedCalc Software, Mariakerke, Belgium).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 30 and 50%, and their cardiac disease status always in compensated status

Condition Spinal Anesthetic Toxicity
Intervention
  • Other: Transthoracic echocardiography
    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).
    Other Name: TTE
  • Drug: Spinal anesthesia
    Spinal anesthesia is introduced with a single intrathecal injection of 15 mg plain ropivacaine (0.75% solution) using a 22 or 25-gauge needle (pencil-point) with the patient in the lateral position.
    Other Name: Neuraxial block
Study Groups/Cohorts
  • Hypotension group
    spinal anesthesia in Hypotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia
    Interventions:
    • Other: Transthoracic echocardiography
    • Drug: Spinal anesthesia
  • Normotension group
    spinal anesthesia IN Normotensive patients with low LV-EF Transthoracic echocardiography of IVC before spinal anaesthesia
    Interventions:
    • Other: Transthoracic echocardiography
    • Drug: Spinal anesthesia
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 27, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Orthopaedic trauma patients Reduced LV-EF (30% <EF<50%)

Exclusion Criteria:

  • patients with right ventricle (RV) dysfunction/ severe valvular diseases/patients with LV-EF<30%
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years to 100 Years   (Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: THEODOSIOS SARANTEAS, Professor 00306973928195 thsaranteas@gmail.com
Contact: Georgia Kostopanagiotou, Professor 00302105832371 stheodosios@gmail.com
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT04001881
Other Study ID Numbers 3332017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party THEODOSIOS SARANTEAS, Attikon Hospital
Study Sponsor Attikon Hospital
Collaborators Not Provided
Investigators
Principal Investigator: THEODOSIOS SARANTEAS, PROFESSOR MEDICAL SCHOOL OF ATHENS, GREECE, EU
PRS Account Attikon Hospital
Verification Date December 2020