Trial Outcomes & Findings for Predict Fluid Responsiveness in Spinal Anesthesia (NCT NCT02070276)
NCT ID: NCT02070276
Last Updated: 2020-07-13
Results Overview
Primary objective is to quantify significant hypotension rate after spinal anesthesia in patients brought to euvolemia according to the Trans-Thoracic Echocardiography and PLRT (Passive Leg Raising Test), compared to patients treated with the current standard. For arterial hypotension, in accordance with the international standard definitions, now define a drop in systolic blood pressure over 50 mmHg from baseline, an absolute value of systolic blood pressure less than 80 mm Hg, a mean arterial pressure below 60 mmHg or hypotension clinically symptomatic (dizziness, pallor, sweating, nausea).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
429 participants
Primary outcome timeframe
30 minutes
Results posted on
2020-07-13
Participant Flow
All consecutive patient undergone spinal anesthesia
Study began at the arrival in the operating block and ended 30 minutes after completion of spinal anaesthesia. The pre-anaesthetic phase running from time 0 to the beginning of spinal anaesthesia, the anaesthetic phase which corresponds to spinal anaesthesia gesture, followed by the post-anaesthetic phase ending 30 minutes spinal anaesthesia
Participant milestones
| Measure |
Standard Clinical Practice
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
|
Trans-Thoracic Echocardiography
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
|
Passive Leg Raising Test
In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
|
|---|---|---|---|
|
Overall Study
STARTED
|
149
|
132
|
148
|
|
Overall Study
COMPLETED
|
149
|
132
|
148
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This analysis was intended as per-protocol analysis
Baseline characteristics by cohort
| Measure |
Standard Clinical Practice
n=149 Participants
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
|
Trans-Thoracic Echocardiography
n=132 Participants
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
|
Passive Leg Raising Test
n=148 Participants
In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
|
Total
n=429 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
80 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
88 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
255 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
52 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
60 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
174 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 18.0 • n=5 Participants • This analysis was intended as per-protocol analysis
|
55.9 years
STANDARD_DEVIATION 18.3 • n=7 Participants • This analysis was intended as per-protocol analysis
|
57.2 years
STANDARD_DEVIATION 18.8 • n=5 Participants • This analysis was intended as per-protocol analysis
|
57.2 years
STANDARD_DEVIATION 18.4 • n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
50 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
57 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
166 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Sex: Female, Male
Male
|
90 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
82 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
91 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
263 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
White
|
149 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
132 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
148 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
429 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=7 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=5 Participants • This analysis was intended as per-protocol analysis
|
0 Participants
n=4 Participants • This analysis was intended as per-protocol analysis
|
|
Region of Enrollment
Switzerland
|
149 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
429 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: Participants with Systemic Hypotensions
Primary objective is to quantify significant hypotension rate after spinal anesthesia in patients brought to euvolemia according to the Trans-Thoracic Echocardiography and PLRT (Passive Leg Raising Test), compared to patients treated with the current standard. For arterial hypotension, in accordance with the international standard definitions, now define a drop in systolic blood pressure over 50 mmHg from baseline, an absolute value of systolic blood pressure less than 80 mm Hg, a mean arterial pressure below 60 mmHg or hypotension clinically symptomatic (dizziness, pallor, sweating, nausea).
Outcome measures
| Measure |
Arm A
n=149 Participants
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
|
Arm B
n=132 Participants
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
|
Arm C
n=148 Participants
In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
|
|---|---|---|---|
|
Percentage of Participants With Systemic Hypotensions
|
68 Participants
|
46 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: Time between operating room entry and spinal anesthesia, up to 30 min.A secondary objective is to quantify the water administration among the three comparison groups before spinal anesthesia, using the patients in the control group as a reference, in order to assess whether these techniques are associated with more fluid administration.
Outcome measures
| Measure |
Arm A
n=149 Participants
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
|
Arm B
n=132 Participants
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
|
Arm C
n=148 Participants
In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
|
|---|---|---|---|
|
Pre-anesthesia Fluid Amount
|
141 ml
Standard Deviation 135
|
336 ml
Standard Deviation 314
|
168 ml
Standard Deviation 237
|
SECONDARY outcome
Timeframe: 30 minutesAnother secondary objective is to quantify the water administration among the three comparison groups after spinal anesthesia, using the patients in the control group as a reference, in order to assess whether the techniques of filling, titrate echocardiographic evaluations and/or response to the mobilization of internal liquids are associated with lower dose, does not require more liquid.
Outcome measures
| Measure |
Arm A
n=149 Participants
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
|
Arm B
n=132 Participants
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
|
Arm C
n=148 Participants
In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
|
|---|---|---|---|
|
Post-anesthesia Fluid Amount
|
312 ml
Standard Deviation 424
|
257 ml
Standard Deviation 266
|
342 ml
Standard Deviation 321
|
Adverse Events
Standard Clinical Practice
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Trans-Thoracic Echocardiography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Passive Leg Raising Test
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Clinical Practice
n=149 participants at risk
This arm is considered the current clinical standard for spinal anesthesia; its used as a control sample and statistical reference. During the induction phase the patient is fitted with a non-invasive blood pressure monitoring, three-lead ECG, pulse oximetry and peripheral intravenous device. The pressure control is set as the standard every 5 minutes until the procedure under spinal anesthesia, the cuff pressure is placed on the arm that is going to be on top during spinal anesthesia.
Data is recorded and vital signs of the patient and is put an infusion of crystalloid (0.9% NaCl or Ringer's acetate) with administration of 500 ml during the entire procedure until the beginning of the operation.
|
Trans-Thoracic Echocardiography
n=132 participants at risk
In addition to the current clinical standard (arm A of the study) a trans-thoracic echocardiography is performed with the aim of assessing patient's volume status, identifying if he is responsive to fluid and could benefit from their administration. The echocardiography is performed with the subcostal projection to assess the size of the abdominal inferior vena cava and its collapsing during breathing.
According to different pre-established parameters, the patient is defined as unresponsive to fluids or responsive. If it's not responsive, he proceed to spinal anesthesia. Otherwise investigators proceed to the administration of crystalloid (NaCl 0.9% or Hartmann's solution second clinical evaluation) and at the end he's rerun an echocardiographic assessment.
Trans-thoracic echocardiography: Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
|
Passive Leg Raising Test
n=148 participants at risk
In addition to the arm A of the study, is performed a measurement of systemic pressure with a patient positioned in semi-recumbent position. After, investigators run the Passive Leg Raising Test (PLRT): the position of the bed is changed in such manner to bring the trunk from 45° to 0° and accordingly the legs from 0° to 45°. Measurements are performed before and during the maneuver (at one minute): an increase of 5% of the systolic blood pressure is interpreted as a responsiveness to liquids.
If the patient is not responsive to fluids, the patient is moving to the spinal anesthesia. If the patient is responsive investigators proceed to bolus administration, the patient returns to the initial PLRT position and is run again the PLRT until the patient is no longer responsive to fluids.
Passive Leg Raising Test: Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
|
|---|---|---|---|
|
Immune system disorders
Vancomycine allergy
|
0.67%
1/149 • Severe adverse events were measured during all surgical procedure just after the anesthesia (30 minutes).
|
0.00%
0/132 • Severe adverse events were measured during all surgical procedure just after the anesthesia (30 minutes).
|
0.00%
0/148 • Severe adverse events were measured during all surgical procedure just after the anesthesia (30 minutes).
|
Additional Information
Dr. med. Samuele Ceruti
Hôpitaux Universitaires de Genève
Phone: 0765661181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place