Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04671680
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2020-11-30
Brief Title:
CNAP vs IABP in Pregnant Women With Placenta Accreta
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Comparison of Continuous Non-Invasive Arterial Blood Pressure to Invasive Arterial Blood Pressure Measurement in Pregnant Women With Placenta Accreta
Status:
RECRUITING
Status Verified Date:
2024-05
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 objective of this study is to investigate a technique to monitor blood pressure in women undergoing cesarean delivery with suspected placenta accreta spectrum To achieve this objective the investigators plan to conduct a prospective observational study with the following aims
Specific Aim 1 Compare concordance between the systolic SBP diastolic DBP and mean arterial blood pressure MAP readings from the continuous non-invasive arterial blood pressure CNAP and IABP at several discrete points throughout the procedure
Specific Aim 2 Determine the feasibility of using CNAP to aid in decision making by examining the parameters of volume responsiveness and arterial elastance at several discrete points throughout the procedure
The investigators hypothesize that the investigators can obtain similar blood pressure monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean delivery with suspected placenta accreta
Specific Aim 1 Compare concordance between the systolic SBP diastolic DBP and mean arterial blood pressure MAP readings from the continuous non-invasive arterial blood pressure CNAP and IABP at several discrete points throughout the procedure
Specific Aim 2 Determine the feasibility of using CNAP to aid in decision making by examining the parameters of volume responsiveness and arterial elastance at several discrete points throughout the procedure
The investigators hypothesize that the investigators can obtain similar blood pressure monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean delivery with suspected placenta accreta
Detailed Description:
Study Overview This is a prospective observational study
Study Procedures Patients who meet inclusion criteria with no exclusions will be approached to provide written informed consent
Enrolled patients will undergo the standard pre-operative evaluation and preparation for cesarean section with possible hysterectomy including evaluation by nursing obstetrics and anesthesiology team placement of 2 large bore IVs arterial line placement and laboratory tests
The patient will then be transported to the OR In the OR the CNAP device will be placed on the patients finger and be given a brief calibration period of 45 seconds As per usual for this procedure each patient will undergo combined spinal epidural anesthesia with our standard cesarean induction dose of hyperbaric intrathecal 075 bupivacaine 15ml intrathecal fentanyl 25 micrograms and intrathecal morphine 250 micrograms The patient will be moved to the supine position with left lateral uterine displacement When a T6 sensory level to pinprick is achieved surgery will be allowed to proceed Throughout the surgery the CNAP and IABP will take continuous reading of blood pressure and hemodynamic variable Labs and additional fluid or blood may be given to the patient as clinically indicated as is common for this procedure Blood work will be obtained from the arterial line used for IABP as is standard practice when an AIBP is in place Other than the addition of the CNAP cuff all other care will be per standard protocol for this procedure
Data Collection In order to assess our primary and secondary outcomes the investigators will be collecting CNAP and AIBP Additional baseline characteristics including but not limited to age race gender BMI and comorbidities will be abstracted from the medical record REDCap will be utilized for data collection and storage
Primary Outcomes SBP MAP DBP reading from the CNAP and AIBP at several discrete points throughout the procedure
Secondary Outcomes Additional comparisons of SBP MAP DBP measurements using CNAP to AIBP and NIBP review of extrapolated data outputs including Stroke Volume Systemic Vascular Resistance Cardiac Output and Stroke Volume Variation from CNAP compared pulse pressure index from pulse oximetry and AIBP and their responsiveness to fluid bolus subgroup analysis of CNAP and AIBP during times significant intravascular volume depletion blood loss or systemic vascular resistance change after spinal anesthesia Relevant clinical data will also be collected including demographic data total estimated blood lose total quantitative blood loss length of hospital stay routine lab results including Hematocrit Fibrinogen coagulation tests lactic acid pH base excess
Study Procedures Patients who meet inclusion criteria with no exclusions will be approached to provide written informed consent
Enrolled patients will undergo the standard pre-operative evaluation and preparation for cesarean section with possible hysterectomy including evaluation by nursing obstetrics and anesthesiology team placement of 2 large bore IVs arterial line placement and laboratory tests
The patient will then be transported to the OR In the OR the CNAP device will be placed on the patients finger and be given a brief calibration period of 45 seconds As per usual for this procedure each patient will undergo combined spinal epidural anesthesia with our standard cesarean induction dose of hyperbaric intrathecal 075 bupivacaine 15ml intrathecal fentanyl 25 micrograms and intrathecal morphine 250 micrograms The patient will be moved to the supine position with left lateral uterine displacement When a T6 sensory level to pinprick is achieved surgery will be allowed to proceed Throughout the surgery the CNAP and IABP will take continuous reading of blood pressure and hemodynamic variable Labs and additional fluid or blood may be given to the patient as clinically indicated as is common for this procedure Blood work will be obtained from the arterial line used for IABP as is standard practice when an AIBP is in place Other than the addition of the CNAP cuff all other care will be per standard protocol for this procedure
Data Collection In order to assess our primary and secondary outcomes the investigators will be collecting CNAP and AIBP Additional baseline characteristics including but not limited to age race gender BMI and comorbidities will be abstracted from the medical record REDCap will be utilized for data collection and storage
Primary Outcomes SBP MAP DBP reading from the CNAP and AIBP at several discrete points throughout the procedure
Secondary Outcomes Additional comparisons of SBP MAP DBP measurements using CNAP to AIBP and NIBP review of extrapolated data outputs including Stroke Volume Systemic Vascular Resistance Cardiac Output and Stroke Volume Variation from CNAP compared pulse pressure index from pulse oximetry and AIBP and their responsiveness to fluid bolus subgroup analysis of CNAP and AIBP during times significant intravascular volume depletion blood loss or systemic vascular resistance change after spinal anesthesia Relevant clinical data will also be collected including demographic data total estimated blood lose total quantitative blood loss length of hospital stay routine lab results including Hematocrit Fibrinogen coagulation tests lactic acid pH base excess
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None