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CompletedNCT03266250Updated Aug 21, 2018

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

An observational study in Spinal Anesthetic Toxicity, Inferior Vena Cava Abnormality and Intraoperative Complications, sponsored by National and Kapodistrian University of Athens. Completed at 1 site in Greece. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by National and Kapodistrian University of Athens · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
70
Ages
70 Years and older
Sex
All
01

Study 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.

Read the detailed description

AIM OF THE STUDY

We hypothesized, therefore, that the preoperative dIVCmax/IVCCI ratio (maximum diameter of inferior vena cava-IVC- at the expiration = dIVCmax and the collapsibility index of the IVC =IVCCI) could greater foresee the incidence of hypotension after spinal anesthesia than the established IVCCI measurements. In light of this hypothesis, we prospectively examined both the dIVCmax/IVCCI ratio and IVCCI before spinal anesthesia in a population who fulfilled predetermined inclusion criteria and we set out to evaluate the diagnostic performance of this indices in predicting spinal-induced hypotension.

METHODOLOGY In the present observational prospective study, consecutive sampling is used to recruit ageing patients (>70 years) who sustained orthopaedic operation under spinal anesthesia.

According to our department policy, the documentation of a cardiac disease in our patients takes place during the routine preoperative anesthetic evaluation always with the cooperation of consultant cardiologists. Patients' medical history, physical examination, ECG, and X-ray assessment are standard practice supplemented by specific exams or tests Echocardiogrphic protocol and measurements A TTE is performed in all patients before spinal anaesthesia (Vivid T8, GE Healthcare, Waukesha, Wisconsin, USA) equipped with a 2-5 MHz phased array transducer. All echocardiograms is carried out by the same anesthesiologist/intensivist (TS), who has 12 years of experience in perioperative echocardiography. All data are saved and stored digitally for off-line analysis.

A standard intraoperative TTE protocol is being used in all patients. and included the following views: subxiphoid4-chamber (SUBX), apical 4-chamber (4CH), apical 2-chamber (2CH), apical 3-chamber (3CH), parasternal long (LAX) and short axis (SAX) windows.

All data are saved and stored digitally for off-line postoperative analysis. The Ejection Fraction (EF) is determined using the Simpson's method. Patients with EF lower than 50% do not continue for the study. The global longitudinal peak systolic strain (GLPSS) is used to assess LV mechanics in the longitudinal axis of LV motion. The TAPSE index is employed for the assessment of the right ventricular function. LV filling pressures in diastole is estimated by the E/Em ratio (E=peak velocity flow in early diastole, Em=the average of peak velocities in early diastole of lateral and septal mitral annulus). In addition, LV dimensions and wall thickness are measured either in short or long parasternal axis view. Stroke volume of the LV is assessed by VTILVOT (pulsed-wave Doppler of velocity time integral in the LV outflow tract).

IVC measurements included its maximum diameter at the end of expiration (dIVCmax), IVCCI during spontaneous in quite breathing, [(IVC maximal diameter - IVC minimal diameter)/IVC maximal diameter] and the ratio (R) of dIVCmax/IVCCI; the IVC diameters were measured in the long axis of the IVC and just proximal to the entry of the hepatic veins.

Anesthetic protocol and measurements. Spinal anaesthesia is introduced with a single intrathecal injection of 0.75% plain ropivacaine using a 22 or 25-gauge needle with the patient in the lateral or sitting position. The dose range is 12mg to 18mg, depending on age and height. Perioperative hemodynamic monitoring is carried out with an indwelling radial artery catheter. Patients with intraoperative mean blood pressure (MBP) ≤65 mmHg, or \<25% of its baseline preoperative value were considered hypotensive. Arterial hypotension related to bone cement application, tourniquet deflation, overt intraoperative/postoperative bleeding (blood loss>150cc) or patients receiving blood transfusion for any reason were not considered.

Statistical analysis Sample size: 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 achieved 80% power to detect significant difference (at a level 0.05) between dIVCmax/IVCCI and dIVCmax.

Data analysis: Quantitative variables and proportions will be compared with the student t-test and chi-square test respectively. Normality was tested by using the Kolmogorov-Smirnov test. Receiver operating characteristic (ROC) curve analysis will be performed to evaluate the diagnostic performance of clinical/Doppler parameters in identifying patients who experienced spinal-induced hypotension. The area under the curve (AUC) and the respective 95% confidence interval (95% CI) are estimated according to Hanley and McNeil. 1 The AUC curves are compared using the method described by DeLong et al. 2. The results are expressed as percentage (%) or mean ± SD; a p value of \<0.05 is considered statistically significant. Statistical analysis will be done with statistical analysis software (SPSS, 17.0, Chicago, IL; MedCalc Software, Mariakerke, Belgium).

  1. Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982 ;143:29-36
  2. DeLong ER, DeLong DM, Clarke- Pearson DL. Comparing the areas under two or more correlate receiver operating characteristic curves: a nonparametric approach. Biometrics 1988; 44:837-845
02

Conditions studied

  • Spinal Anesthetic Toxicity
  • Inferior Vena Cava Abnormality
  • Intraoperative Complications

Keywords

  • inferior vena caca ultrasound
03

In context

Intraoperative Complications

92 studies on the registry are indexed under Intraoperative Complications; 19 are open to participants now.

This study's enrollment of 70 is below the median of 200 across 39 observational studies indexed under Intraoperative Complications.

Browse Intraoperative Complications studies →

Lead sponsor

National and Kapodistrian University of Athens is the lead sponsor of 176 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Elderly orthopaedic patients

Eligibility criteria

Inclusion Criteria: patients with AHA/ACC stage I, II or III with their cardiac disease status in compensated status -

Exclusion Criteria: patients with AHA/ACC stage IV

-

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Procedurespinal anesthesia

    Transthoracic echocardiography of inferior vena cava before spinal anesthesia

06

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. Echocardiographic or clinical measurements

    To identify other echocardiographic or clinical measurements that can predict an intraoperative spinal-induced haemodynamic instability

    Time frame: 6 months

07

Study locations

1 site
  • ATTIKON University General Hospital
    Athens, Attika 15562, Greece
08

References and documents

Publications

  • 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. PubMed 26771910 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Jul 2018, 11 months.

Of 23 observational studies under Intraoperative Complications, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 17. This study's 11 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2017
First posted
Aug 30, 2017
StartActual
Aug 15, 2017
Primary completionActual
Jul 20, 2018
CompletionActual
Jul 20, 2018
Last update
Aug 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03266250
Responsible party
Theodosis Saranteas, MD (Assistant Professor, National and Kapodistrian University of Athens) — Principal investigator
First posted
Aug 30, 2017
Start date
Aug 15, 2017
Primary completion
Jul 20, 2018
Completion
Jul 20, 2018
Last update
Aug 21, 2018

Study contacts

Theodosis Saranteas, MD
principal investigator · National and Kapodistrian University of Athens, School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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