Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04001881 |
| Other study ID # |
3332017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
May 5, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
Attikon Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 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 Simpson's 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 (E/Em 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 (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).
IVC measurements include 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 12 to 18 mg (average15 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 blood transfusion for any reason is not
considered in our statistical analysis.
Data analysis:A pilot study of 18 patients revealed a detected area under the ROC curve (AUC)
of 0.89 for dIVCmax-to-IVCCI, and for IVCCI 0.74, with rank correlation between the two
assays being 0.88 in positive and 0.62 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 0.05) 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.
