Trial Outcomes & Findings for Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients? (NCT NCT02271477)
NCT ID: NCT02271477
Last Updated: 2017-08-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
30 minute after spinal anesthesia
Results posted on
2017-08-31
Participant Flow
Participant milestones
| Measure |
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.
|
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). 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%
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
|
Overall Study
COMPLETED
|
80
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients?
Baseline characteristics by cohort
| Measure |
Wild-Type
n=80 Participants
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.
|
Echocardiography
n=80 Participants
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).
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 16.7 • n=93 Participants
|
56.6 years
STANDARD_DEVIATION 18.8 • n=4 Participants
|
57.74 years
STANDARD_DEVIATION 18.18 • n=27 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
87 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Weight
|
78.01 Kg
STANDARD_DEVIATION 18.40 • n=93 Participants
|
76.07 Kg
STANDARD_DEVIATION 17.59 • n=4 Participants
|
76.52 Kg
STANDARD_DEVIATION 25 • n=27 Participants
|
|
Systolic blood pressure (SBP) pre-induction
|
136 mmHg
STANDARD_DEVIATION 22 • n=93 Participants
|
132 mmHg
STANDARD_DEVIATION 21 • n=4 Participants
|
134.05 mmHg
STANDARD_DEVIATION 21.95 • n=27 Participants
|
|
Mean blood pressure (MBP) pre-induction
|
94.5 mmHg
STANDARD_DEVIATION 13.99 • n=93 Participants
|
91.5 mmHg
STANDARD_DEVIATION 13 • n=4 Participants
|
93 mmHg
STANDARD_DEVIATION 13.21 • n=27 Participants
|
|
Heart Rate (HR) pre-induction
|
70 bpm
STANDARD_DEVIATION 16 • n=93 Participants
|
72 bpm
STANDARD_DEVIATION 12 • n=4 Participants
|
71.88 bpm
STANDARD_DEVIATION 12.27 • n=27 Participants
|
|
B-blockers therapy
B-blockers
|
7 participants
n=93 Participants
|
1 participants
n=4 Participants
|
8 participants
n=27 Participants
|
|
B-blockers therapy
No therapy
|
73 participants
n=93 Participants
|
79 participants
n=4 Participants
|
152 participants
n=27 Participants
|
|
ACE-inhibitors therapy
ACE-inhibitors
|
9 participants
n=93 Participants
|
5 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
ACE-inhibitors therapy
No therapy
|
71 participants
n=93 Participants
|
75 participants
n=4 Participants
|
146 participants
n=27 Participants
|
|
Crystalloid therapy
|
80 participants
n=93 Participants
|
80 participants
n=4 Participants
|
160 participants
n=27 Participants
|
|
Type of crystalloid therapy
Ringer
|
80 participants
n=93 Participants
|
80 participants
n=4 Participants
|
160 participants
n=27 Participants
|
|
Type of crystalloid therapy
NaCl 0.9%
|
0 participants
n=93 Participants
|
0 participants
n=4 Participants
|
0 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 30 minute after spinal anesthesiaPopulation: Rate of arterial hypotension after standardized 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.
Outcome measures
| Measure |
Wild-Type
n=80 Participants
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.
|
Echocardiography
n=80 Participants
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).
|
|---|---|---|
|
Rate of Arterial Hypotension
|
42.5 percentage of participants
|
27.5 percentage of participants
|
SECONDARY outcome
Timeframe: 30 minutes after spinal anesthesiaTo assess if there is a difference between all treatments in the total quantity of fluids amount
Outcome measures
| Measure |
Wild-Type
n=80 Participants
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.
|
Echocardiography
n=80 Participants
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).
|
|---|---|---|
|
Total Amount of IV Fluid at the End of the Procedure
|
350 milliliters (mL)
Interval 200.0 to 550.0
|
665 milliliters (mL)
Interval 250.0 to 800.0
|
SECONDARY outcome
Timeframe: 30 minutes after spinal anesthesiaTotal amount of vasoactive drug administered for each group; for "vasoactive drug" we intended the use both of atropine than vascular amine
Outcome measures
| Measure |
Wild-Type
n=80 Participants
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.
|
Echocardiography
n=80 Participants
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).
|
|---|---|---|
|
Percentage of Participants Administered Vasoactive Drug
|
13.51 percentage of participants
|
6.49 percentage of participants
|
SECONDARY outcome
Timeframe: From time 0 to 30 minutes after spinal anesthesiaTime employed to execute all procedure from the start of the study till 30 minutes after the end of the procedure
Outcome measures
| Measure |
Wild-Type
n=80 Participants
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.
|
Echocardiography
n=80 Participants
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).
|
|---|---|---|
|
Time of Procedures
|
22 minutes
Standard Deviation 13
|
24 minutes
Standard Deviation 10
|
Adverse Events
Wild-Type
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Echocardiography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. med. Andrea Saporito, Vice-Director of Anaesthesiology
Ente Ospedaliero Cantonale
Phone: 091/811.89.78
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place