Anesthesia; Adverse Effect, Spinal and Epidural, Fluid Overload, Regional Anesthesia Morbidity
Conditions
Keywords
Fluid replacement, Trans-Thoracic Echocardiography, Spinal Anesthesia, Empirical Volemic Repletion
Brief summary
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
Detailed description
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.
Interventions
DEVICEUltrasound-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
Sponsors
Ente Ospedaliero Cantonale, Bellinzona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* both sexes * grater than 18 year old * requiring spinal anesthesia * classified according to American Society of Anesthesiology (ASA) level as 1, 2 or 3
Exclusion criteria
* patients required invasive blood pressure monitoring (arterial/pulmonary catheter, thermodilution catheter), * patients show signs of pre-procedural hypotension (defined as two measurements of systolic arterial pressure less than 80 mmHg and/or mean arterial pressure less than 60 mmHg), * patients unable to give informed consent to language barriers, mental retard or any reduction in own ability to understand or give their informed consent, * patient in which is not possible to perform spinal anesthesia for patient's refusal or technical difficulties in sampling, * patients with International Normalized Ratio (INR) greater than 1.5 and/or activated Partial Thrombin Time in therapeutic range (more than 1.5 - 2 times the patient's normal values) and/or anti-factor X activity in therapeutic range * patients with thrombocytopenia less than 50 G/l.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Arterial Hypotension | 30 minute after spinal anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of IV Fluid at the End of the Procedure | 30 minutes after spinal anesthesia | To assess if there is a difference between all treatments in the total quantity of fluids amount |
| Percentage of Participants Administered Vasoactive Drug | 30 minutes after spinal anesthesia | Total amount of vasoactive drug administered for each group; for vasoactive drug we intended the use both of atropine than vascular amine |
| Time of Procedures | From time 0 to 30 minutes after spinal anesthesia | Time employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wild-Type 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. | 80 |
| Echocardiography 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. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | Total | Wild-Type | Echocardiography |
|---|---|---|---|
| ACE-inhibitors therapy ACE-inhibitors | 14 participants | 9 participants | 5 participants |
| ACE-inhibitors therapy No therapy | 146 participants | 71 participants | 75 participants |
| Age, Continuous | 57.74 years STANDARD_DEVIATION 18.18 | 59.7 years STANDARD_DEVIATION 16.7 | 56.6 years STANDARD_DEVIATION 18.8 |
| B-blockers therapy B-blockers | 8 participants | 7 participants | 1 participants |
| B-blockers therapy No therapy | 152 participants | 73 participants | 79 participants |
| Crystalloid therapy | 160 participants | 80 participants | 80 participants |
| Heart Rate (HR) pre-induction | 71.88 bpm STANDARD_DEVIATION 12.27 | 70 bpm STANDARD_DEVIATION 16 | 72 bpm STANDARD_DEVIATION 12 |
| Mean blood pressure (MBP) pre-induction | 93 mmHg STANDARD_DEVIATION 13.21 | 94.5 mmHg STANDARD_DEVIATION 13.99 | 91.5 mmHg STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 87 Participants | 44 Participants | 43 Participants |
| Sex: Female, Male Male | 73 Participants | 36 Participants | 37 Participants |
| Systolic blood pressure (SBP) pre-induction | 134.05 mmHg STANDARD_DEVIATION 21.95 | 136 mmHg STANDARD_DEVIATION 22 | 132 mmHg STANDARD_DEVIATION 21 |
| Type of crystalloid therapy NaCl 0.9% | 0 participants | 0 participants | 0 participants |
| Type of crystalloid therapy Ringer | 160 participants | 80 participants | 80 participants |
| Weight | 76.52 Kg STANDARD_DEVIATION 25 | 78.01 Kg STANDARD_DEVIATION 18.4 | 76.07 Kg STANDARD_DEVIATION 17.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
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
Population: Rate of arterial hypotension after standardized spinal anesthesia
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wild-Type | Rate of Arterial Hypotension | 42.5 percentage of participants |
| Echocardiography | Rate of Arterial Hypotension | 27.5 percentage of participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wild-Type | Percentage of Participants Administered Vasoactive Drug | 13.51 percentage of participants |
| Echocardiography | Percentage of Participants Administered Vasoactive Drug | 6.49 percentage of participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Wild-Type | Time of Procedures | 22 minutes | Standard Deviation 13 |
| Echocardiography | Time of Procedures | 24 minutes | Standard Deviation 10 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Wild-Type | Total Amount of IV Fluid at the End of the Procedure | 350 milliliters (mL) |
| Echocardiography | Total Amount of IV Fluid at the End of the Procedure | 665 milliliters (mL) |