Spinal Anesthetic ToxicityNCT03266250
Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension
An observational study of Spinal Anesthetic Toxicity and Inferior Vena Cava Abnormality, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthetic Toxicity, Inferior Vena Cava Abnormality, Intraoperative Complications
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 15 Aug 2017to 20 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Elderly orthopaedic patients
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension in Elderly Orthopaedic Patients
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.
Read more
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).
- Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982 ;143:29-36
- 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
- Being tested
- spinal anesthesia
- Keywords
- inferior vena caca ultrasound
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
Transthoracic echocardiography of inferior vena cava before spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| spinal anesthesia Hypotensive patients | Transthoracic echocardiography of IVC before spinal anaesthesia Receives: Procedure: spinal anesthesia | |
| spinal anesthesia Normotensive patients | Transthoracic echocardiography of IVC before spinal anaesthesia Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start15 Aug 2017
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Anesthetic ToxicityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theodosis Saranteas, MD, National and Kapodistrian University of Athens
- Investigators
- Theodosis Saranteas, MD, Principal investigator, National and Kapodistrian University of Athens, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266250
- Sponsor's protocol ID
- ED399,09-24-2015
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Echocardiography of Inferior Vena Cava Before Spinal Anesthesia Can Predict Hypotension in Elderly Orthopaedic Patients
- ClinicalTrials.gov ID
- NCT03266250
- Acronym / sponsor ID
- ED399,09-24-2015
- Keywords
- inferior vena caca ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
- Hanley JA, McNeil BJ. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology 1982 ;143:29-36
- 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal anesthesia Hypotensive patients | – | Procedure: spinal anesthesiaTransthoracic echocardiography of IVC before spinal anaesthesia |
| spinal anesthesia Normotensive patients | – | Procedure: spinal anesthesiaTransthoracic echocardiography of IVC before spinal anaesthesia |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Elderly orthopaedic patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaTransthoracic echocardiography of inferior vena cava before spinal anesthesia | Procedure or surgery | spinal anesthesia Hypotensive patients, spinal anesthesia Normotensive patients |
Primary outcome
Preoperative performance of the dIVCmax/IVCCI ratio
Time frame: 6 months
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
1 secondary outcome
Echocardiographic or clinical measurements
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Background: PubMed 26771910Zhang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodosis Saranteas, MD principal investigator
National and Kapodistrian University of Athens, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthetic Toxicity and Inferior Vena Cava Abnormality, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative performance of the dIVCmax/IVCCI ratio (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.