An interventional study of Ultrasound-guided volemic repletion in Fluid Overload, Anesthesia; Adverse Effect, Spinal and Epidural and Regional Anesthesia Morbidity, sponsored by Ente Ospedaliero Cantonale, Bellinzona. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-31.
Sponsored by Ente Ospedaliero Cantonale, Bellinzona · Not applicable, Interventional, and Prevention
Aim of this study is to determine whether Inferior Vena Cava analyzed by trans-thoracic echocardiography is an effective method to guide titrated fluid repletion in non critical patients, in order both to decrease post procedural significant hypotension rate and to avoid unnecessary fluid overload in patients undergoing spinal anesthesia for elective surgical procedures
The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
In addition to the current clinical standard, for the second arm of the study, a trans-thoracic echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.
840 studies on the registry are indexed under Edema; 92 are open to participants now.
This study's enrollment of 160 is above the median of 52 across 608 interventional studies indexed under Edema.
Browse Edema studies →Ente Ospedaliero Cantonale, Bellinzona is the lead sponsor of 38 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.
Device: Ultrasound-guided volemic repletion
After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36% from baseline level during normal breath
Also known as: IVCUS
Rate of Arterial Hypotension
To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.
Time frame: 30 minute after spinal anesthesia
Total Amount of IV Fluid at the End of the Procedure
To assess if there is a difference between all treatments in the total quantity of fluids amount
Time frame: 30 minutes after spinal anesthesia
Percentage of Participants Administered Vasoactive Drug
Total amount of vasoactive drug administered for each group; for "vasoactive drug" we intended the use both of atropine than vascular amine
Time frame: 30 minutes after spinal anesthesia
Time of Procedures
Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure
Time frame: From time 0 to 30 minutes after spinal anesthesia
| Milestone | Wild-Type | Echocardiography |
|---|---|---|
| Started | 80 | 80 |
| Completed | 80 | 80 |
| Not completed | 0 | 0 |
To compare rates of arterial hypotension (previously define by international standard) after spinal anesthesia in patients who have undergone volemic optimization according to Trans-thoracic Echocardiography with patients who have been treated according to the current standard on the intention to treat population.
| percentage of participants | Wild-Type | Echocardiography |
|---|---|---|
| Rate of Arterial Hypotension | 42.5 | 27.5 |
To assess if there is a difference between all treatments in the total quantity of fluids amount
| milliliters (mL) | Wild-Type | Echocardiography |
|---|---|---|
| Total Amount of IV Fluid at the End of the Procedure | 350 (200 to 550) | 665 (250 to 800) |
Total amount of vasoactive drug administered for each group; for "vasoactive drug" we intended the use both of atropine than vascular amine
| percentage of participants | Wild-Type | Echocardiography |
|---|---|---|
| Percentage of Participants Administered Vasoactive Drug | 13.51 | 6.49 |
Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure
| minutes | Wild-Type | Echocardiography |
|---|---|---|
| Time of Procedures | 22 ± 13 | 24 ± 10 |
Collected over Serious Adverse Events are checked till the end of the surgical procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Wild-Type | — | 0/80 (0%) | 0/80 (0%) |
| Echocardiography | — | 0/80 (0%) | 0/80 (0%) |
| Age, Continuous(years) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| Mean | 59.7 ± 16.7 | 56.6 ± 18.8 | 57.74 ± 18.18 |
| Sex: Female, Male(Participants) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| Female | 44 | 43 | 87 |
| Male | 36 | 37 | 73 |
| Weight(Kg) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| Mean | 78.01 ± 18.40 | 76.07 ± 17.59 | 76.52 ± 25 |
| Systolic blood pressure (SBP) pre-induction(mmHg) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| Mean | 136 ± 22 | 132 ± 21 | 134.05 ± 21.95 |
| Mean blood pressure (MBP) pre-induction(mmHg) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| Mean | 94.5 ± 13.99 | 91.5 ± 13 | 93 ± 13.21 |
| Heart Rate (HR) pre-induction(bpm) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| Mean | 70 ± 16 | 72 ± 12 | 71.88 ± 12.27 |
| B-blockers therapy(participants) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| B-blockers | 7 | 1 | 8 |
| No therapy | 73 | 79 | 152 |
| ACE-inhibitors therapy(participants) | Wild-Type | Echocardiography | Total |
|---|---|---|---|
| ACE-inhibitors | 9 | 5 | 14 |
| No therapy | 71 | 75 | 146 |
2 further baseline measures are reported on the registry.
The record gives a start of May 2014, a primary completion of Nov 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2015, 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ente Ospedaliero Cantonale, Bellinzona