Ignite Creation Date:
2024-05-06 @ 1:54 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01928797
Status:
COMPLETED
Last Update Posted:
2017-11-14
First Post:
2012-10-02
Brief Title:
Ninvasive Cardiac Output Measurements During Cesarean Delivery Under Spinal Anesthesia
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
To Determine if the Cardiac Output Monitoring During Cesarean Delivery Under Spinal Anesthesia Will Change Our Clinical Practice of Using Vasopressors
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to learn more about how the heart works during cesarean delivery under spinal anesthesia medicines given in the spine that numb parts of your body to block pain in women The investigators would like to find out if the information about the heart can help in treating blood pressure changes that occur during the cesarean delivery The investigators would also like to find out if this information can help reduce the chances of nausea and vomiting during the cesarean delivery
The activity of the heart changes during spinal anesthesia and cesarean section In the past a sensor placed directly into the heart was the only way to see how the heart worked Currently there are monitors that can sense the hearts activity via sensors that are placed on the skin during cesarean delivery
In this study the investigators will use the ICON cardiac output ICON monitor The ICON monitor is approved by the US Food and Drug Administration FDA to monitor check the activity of your heart
This study aims to
1 Determine if additional cardiac output measurements help anesthesiologists maintain appropriate hemodynamics as defined as within 20 of baseline BP and if it changed their choice of vasopressors primary outcome
2 Determine if additional cardiac output measurements help to decrease the incidence of nausea and vomiting during cesarean delivery secondary outcome
The activity of the heart changes during spinal anesthesia and cesarean section In the past a sensor placed directly into the heart was the only way to see how the heart worked Currently there are monitors that can sense the hearts activity via sensors that are placed on the skin during cesarean delivery
In this study the investigators will use the ICON cardiac output ICON monitor The ICON monitor is approved by the US Food and Drug Administration FDA to monitor check the activity of your heart
This study aims to
1 Determine if additional cardiac output measurements help anesthesiologists maintain appropriate hemodynamics as defined as within 20 of baseline BP and if it changed their choice of vasopressors primary outcome
2 Determine if additional cardiac output measurements help to decrease the incidence of nausea and vomiting during cesarean delivery secondary outcome
Detailed Description:
Most women who undergo elective cesarean delivery in our hospital have spinal anesthesia for the surgery You will receive standard spinal anesthesia techniques whether or not you take part in this study You will be asked to sign a separate clinical consent form for the spinal anesthesia and for your cesarean delivery
After the anesthesiologist places your spinal anesthesia the investigator will record your blood pressure every two minutes as is the standard practice in our institution An anesthesiologist is a doctor who specializes in giving drugs or other agents to prevent or relieve pain during surgery or other procedures The investigator will also continuously record your heart rate and the amount of oxygen in your blood as is the standard practice If needed the anesthesiologist will give you medications to maintain your blood pressure
In addition to the standard procedures described above additional monitoring checking of your heart will be performed as part of this study The investigator will use the ICON monitor to measure the amount of blood pumped by each heart beat
The anesthesiologist will put on the sensors sticky pads There are four sticky pads that are similar to what is used during electrocardiograms EKGs Two sensors are placed on the left side of your neck and two on the left side of your trunk The sensors have wires attached that will be plugged into a small heart monitor device that records the information
The investigators will place the sensors on you before you receive the spinal anesthesia The sensors will record what your heart is doing before placement of spinal anesthesia until the end of your surgery
The investigators will assign you by chance like a coin toss to one of the following groups
Group Study Your anesthesiologist will have access to the amount of blood that is pumped during each heart beat The anesthesiologist will treat and maintain the amount of blood pumped during each beat so that it is within the normal range
Group Control Your anesthesiologist will NOT have access to the amount of blood that is pumped during each heart beat The anesthesiologist will treat and maintain your blood pressure throughout your delivery This is the current routine care
The control group and the study group will receive spinal anesthesia as is adapted in our institution HR and BP will be measured every two minutes as is normal practice Cardiac output will be measured in all patients in both groups The subjects will have four surface ECG electrodes attached to the left side of the neck and the lower thorax at the level of the xiphoid Baseline hemodynamic parameters SV stroke volume HR heart rate CO cardiac output SVV stroke volume variation and SVR systemic vascular resistance will be determined before placing spinal anesthesia Continuous CO data will be recorded by the unit
In the study group phenylephrine and ephedrine will be used depending on the blood pressure and cardiac output data If the CO is normal and BP is below 20 of baseline phenylephrine boluses of 40 micrograms at two minute interval BP recording time will be used to maintain BP within 20 of the baseline If the BP is normal but CO is lower than 20 baseline ephedrine boluses 10 mg will be used If BP and CO is lower a combination of both phenylephrine and ephedrine will be used
In the control group the phenylephrine and ephedrine will be used as considered appropriate to maintain BP within 20 of baseline The CO data will be blinded to the anesthesiologists in the control group
Study group algorithm in detail
1 If SBP20 CO is within 20 of baseline Phenylephrine 40 mic boluses to bring BP within 20 of the baseline
2 If CO 20 and BP is within 20 of baseline ephedrine boluses to bring the CO
3 If both are below 20 of baseline phenylephrine 40 mic boluses and ephedrine 10 mg together will be used at 2 min intervals until both reach to within 20 of baseline
4 If SBP is normal and CO is greater than 20 baseline no treatment needed
5 If CO is normal and SBP is greater than 20 no treatment needed
Control group
Although BP and CO are being measured in the control group CO data is blinded to the clinician Therefore the clinician will use SPB data and current practice instincts to choose either of vasopressors considered appropriate to treat hypotension
The anesthesiologist has his or her discretion of treating BP or CO if these parameters are not corrected with above protocol
Fluid inputs and outputs will be noted that includes blood loss Apgar scores of newborns will be obtained from neonatologists assessment Incidence of nausea and vomiting and medications used will be also noted
The regional techniques will follow the standards adopted by our institution Most placements are done in the sitting position After disinfecting the skin with betadine in the usual fashion the patients back will be draped with a sterile clear plastic and local anesthetic 15 lidocaine 2ml injected at the site of placement A 3 12 -inch 25-gauge Whittaker needle will be inserted into the spinal space at either the L3-L4 or L4-L5 Once the clear Cerebrospinal fluid CSF is obtained spinal medication 16 - 18 ml of bupivacaine 075 with hyperbaric dextrose 10 µgm fentanyl 200 µgm morphine Most patients receive oxytocin infusion titrated to uterine tone 3-5 unitshr and ondansetron for prevention of postoperative nausea and vomiting after delivery of the baby
After the anesthesiologist places your spinal anesthesia the investigator will record your blood pressure every two minutes as is the standard practice in our institution An anesthesiologist is a doctor who specializes in giving drugs or other agents to prevent or relieve pain during surgery or other procedures The investigator will also continuously record your heart rate and the amount of oxygen in your blood as is the standard practice If needed the anesthesiologist will give you medications to maintain your blood pressure
In addition to the standard procedures described above additional monitoring checking of your heart will be performed as part of this study The investigator will use the ICON monitor to measure the amount of blood pumped by each heart beat
The anesthesiologist will put on the sensors sticky pads There are four sticky pads that are similar to what is used during electrocardiograms EKGs Two sensors are placed on the left side of your neck and two on the left side of your trunk The sensors have wires attached that will be plugged into a small heart monitor device that records the information
The investigators will place the sensors on you before you receive the spinal anesthesia The sensors will record what your heart is doing before placement of spinal anesthesia until the end of your surgery
The investigators will assign you by chance like a coin toss to one of the following groups
Group Study Your anesthesiologist will have access to the amount of blood that is pumped during each heart beat The anesthesiologist will treat and maintain the amount of blood pumped during each beat so that it is within the normal range
Group Control Your anesthesiologist will NOT have access to the amount of blood that is pumped during each heart beat The anesthesiologist will treat and maintain your blood pressure throughout your delivery This is the current routine care
The control group and the study group will receive spinal anesthesia as is adapted in our institution HR and BP will be measured every two minutes as is normal practice Cardiac output will be measured in all patients in both groups The subjects will have four surface ECG electrodes attached to the left side of the neck and the lower thorax at the level of the xiphoid Baseline hemodynamic parameters SV stroke volume HR heart rate CO cardiac output SVV stroke volume variation and SVR systemic vascular resistance will be determined before placing spinal anesthesia Continuous CO data will be recorded by the unit
In the study group phenylephrine and ephedrine will be used depending on the blood pressure and cardiac output data If the CO is normal and BP is below 20 of baseline phenylephrine boluses of 40 micrograms at two minute interval BP recording time will be used to maintain BP within 20 of the baseline If the BP is normal but CO is lower than 20 baseline ephedrine boluses 10 mg will be used If BP and CO is lower a combination of both phenylephrine and ephedrine will be used
In the control group the phenylephrine and ephedrine will be used as considered appropriate to maintain BP within 20 of baseline The CO data will be blinded to the anesthesiologists in the control group
Study group algorithm in detail
1 If SBP20 CO is within 20 of baseline Phenylephrine 40 mic boluses to bring BP within 20 of the baseline
2 If CO 20 and BP is within 20 of baseline ephedrine boluses to bring the CO
3 If both are below 20 of baseline phenylephrine 40 mic boluses and ephedrine 10 mg together will be used at 2 min intervals until both reach to within 20 of baseline
4 If SBP is normal and CO is greater than 20 baseline no treatment needed
5 If CO is normal and SBP is greater than 20 no treatment needed
Control group
Although BP and CO are being measured in the control group CO data is blinded to the clinician Therefore the clinician will use SPB data and current practice instincts to choose either of vasopressors considered appropriate to treat hypotension
The anesthesiologist has his or her discretion of treating BP or CO if these parameters are not corrected with above protocol
Fluid inputs and outputs will be noted that includes blood loss Apgar scores of newborns will be obtained from neonatologists assessment Incidence of nausea and vomiting and medications used will be also noted
The regional techniques will follow the standards adopted by our institution Most placements are done in the sitting position After disinfecting the skin with betadine in the usual fashion the patients back will be draped with a sterile clear plastic and local anesthetic 15 lidocaine 2ml injected at the site of placement A 3 12 -inch 25-gauge Whittaker needle will be inserted into the spinal space at either the L3-L4 or L4-L5 Once the clear Cerebrospinal fluid CSF is obtained spinal medication 16 - 18 ml of bupivacaine 075 with hyperbaric dextrose 10 µgm fentanyl 200 µgm morphine Most patients receive oxytocin infusion titrated to uterine tone 3-5 unitshr and ondansetron for prevention of postoperative nausea and vomiting after delivery of the baby
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None