Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
20 participants
OBSERVATIONAL
2021-01-15
2025-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
NCT02912403
Non-invasive Versus Invasive Blood Pressure Measurement in the Morbidly Obese Parturient With Severe Preeclampsia
NCT03222414
Plasma Concentration of Biological Markers in Placental Abruption
NCT03782168
Ambulatory Blood Pressure Monitoring in Post-Partum Pre-Eclamptic Patients
NCT02943122
Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure
NCT01029691
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 patient's 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 0.75% bupivacaine 1.5ml, 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pregnant women with suspected placenta accreta
Pregnant women undergoing cesarean delivery with suspected placenta accreta spectrum.
LiDCO CNAP Monitoring Equipment
A continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LiDCO CNAP Monitoring Equipment
A continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients with cardiac arrhythmia
* Vascular pathologies of the upper limbs (recent vascular surgery, Reynaud's disease, vascular stenosis)
* Contraindication to neuraxial anesthesia
* Emergent cases
* Droplet or airborne precautions (as determined by BIDMC infection control policy)
18 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Phillip Hess
Associate Professor of Anaesthesia
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John J. Kowalczyk, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
Creanga AA, Berg CJ, Syverson C, Seed K, Bruce FC, Callaghan WM. Pregnancy-related mortality in the United States, 2006-2010. Obstet Gynecol. 2015 Jan;125(1):5-12. doi: 10.1097/AOG.0000000000000564.
Creanga AA, Berg CJ, Ko JY, Farr SL, Tong VT, Bruce FC, Callaghan WM. Maternal mortality and morbidity in the United States: where are we now? J Womens Health (Larchmt). 2014 Jan;23(1):3-9. doi: 10.1089/jwh.2013.4617.
Chung E, Chen G, Alexander B, Cannesson M. Non-invasive continuous blood pressure monitoring: a review of current applications. Front Med. 2013 Mar;7(1):91-101. doi: 10.1007/s11684-013-0239-5. Epub 2013 Jan 23.
Stenglova A, Benes J. Continuous Non-Invasive Arterial Pressure Assessment during Surgery to Improve Outcome. Front Med (Lausanne). 2017 Nov 17;4:202. doi: 10.3389/fmed.2017.00202. eCollection 2017.
Maheshwari K, Khanna S, Bajracharya GR, Makarova N, Riter Q, Raza S, Cywinski JB, Argalious M, Kurz A, Sessler DI. A Randomized Trial of Continuous Noninvasive Blood Pressure Monitoring During Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):424-431. doi: 10.1213/ANE.0000000000003482.
Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.
Rogge DE, Nicklas JY, Schon G, Grothe O, Haas SA, Reuter DA, Saugel B. Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system). Anesth Analg. 2019 Mar;128(3):477-483. doi: 10.1213/ANE.0000000000003943.
Sumiyoshi M, Maeda T, Miyazaki E, Hotta N, Sato H, Hamaguchi E, Kanazawa H, Ohnishi Y, Kamei M. Accuracy of the ClearSight system in patients undergoing abdominal aortic aneurysm surgery. J Anesth. 2019 Jun;33(3):364-371. doi: 10.1007/s00540-019-02632-6. Epub 2019 Mar 23.
Meidert AS, Nold JS, Hornung R, Paulus AC, Zwissler B, Czerner S. The impact of continuous non-invasive arterial blood pressure monitoring on blood pressure stability during general anaesthesia in orthopaedic patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):716-722. doi: 10.1097/EJA.0000000000000690.
Cecconi M, Monge Garcia MI, Gracia Romero M, Mellinghoff J, Caliandro F, Grounds RM, Rhodes A. The use of pulse pressure variation and stroke volume variation in spontaneously breathing patients to assess dynamic arterial elastance and to predict arterial pressure response to fluid administration. Anesth Analg. 2015 Jan;120(1):76-84. doi: 10.1213/ANE.0000000000000442.
Hohn A, Defosse JM, Becker S, Steffen C, Wappler F, Sakka SG. Non-invasive continuous arterial pressure monitoring with Nexfin does not sufficiently replace invasive measurements in critically ill patients. Br J Anaesth. 2013 Aug;111(2):178-84. doi: 10.1093/bja/aet023. Epub 2013 Mar 13.
Gupta D, Soskin V, Marjanovic M, Amhaz H, Mazumdar A. CONTINUOUS NON-INVASIVE ARTERIAL PRESSURE DEVICE AS AN ADJUNCT TO RECOGNIZE FLUCTUATING BLOOD PRESSURES DURING ELECTIVE CESAREAN SECTION UNDER SUBARACHNOID BLOCKADE (SAB). Middle East J Anaesthesiol. 2016 Feb;23(4):385-400.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020P001099
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.