Continuous Non-invasive Blood Pressure Measurement in C-section (ClearBirth)

February 13, 2023 updated by: Sascha Treskatsch, Charite University, Berlin, Germany

Influence of Continuous Non-invasive Blood Pressure Measurement on Fetal Outcome After Caesarean Section ("ClearBirth")

The caesarean section is a frequently performed procedure in obstetrics and accounts for about 30% of all births in Germany. 55% to 68% of all caesarean sections are performed under spinal anesthesia. A possible side effect of spinal anesthesia is arterial hypotension with a prevalence of 70% to 80%. A placental hypoperfusion in the context of a reduced preload due to hypotension can reduce the fetal outcome. Early diagnosis and treatment of the hypotensive episode could reduce and at best prevent increased fetal morbidity.

Due to their invasiveness due to the necessity of puncturing a distal artery of the extremity and the insertion of a catheter, established continuous blood pressure measurement procedures have disadvantages such as potential circulatory disorders of the hand, infections, bleeding and thrombosis and are therefore often not indicated in the context of an elective sectio. Non-invasive procedures such as NIBP, however, are discontinuous and may make a timely diagnosis of hypotension more difficult and delay therapy. The ClearSightTM system, which allows a continuous non-invasive blood pressure measurement, has been used in hip and knee joint surgery. There, a good correlation with invasive blood pressure measurements was found, particularly with regard to systolic and mean arterial pressure. An application in obstetrics has not yet been investigated. Due to the continuous measurement provided by ClearSightTM, continuous monitoring of blood pressure appears to be ensured, so that a faster reaction to previously undetected fluctuations in blood pressure can be expected compared to interval measurement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The determination of arterial blood pressure is a basic monitoring measure during spinal anaesthesia in obstetrics for the operative delivery of the child via the caesarean section. Adequate arterial blood pressure is essential to ensure adequate placental perfusion, sufficient cerebral perfusion pressure of the mother and is the basis for any hemodynamic optimization to significantly improve patient outcome.

Up to now, two standard methods for determining blood pressure have always been the oscillating non-invasive, intermittent blood pressure measurement (NIBP) and the invasive continuous blood pressure measurement (IBP). The NIBP derives blood pressure values using upper arm cuffs at defined intervals. As a result, no continuous measurement is possible and nerve damage and pain are risks of this method. The indication for the establishment of IBP is often not given due to potential side effects such as aneurysm formation, infections, thrombosis and circulatory impairment of the hand. The application of a novel non-invasive, patch-clamp-based continuous blood pressure measurement system (ClearSightTM, Edwards Lifesciences Corporation, Irvine, California, USA) promises to combine the advantages of NIBP, namely non-invasiveness and IBP, the continuous pressure measurement. So far, there have been no randomized, controlled trials for application. Spinal anesthesia is a widespread anaesthetic procedure for performing Caesarean sections. Within the clinical standard, an intermittent blood pressure measurement is used at intervals of 2 to 5 minutes. Continuous invasive blood pressure measurement is not a standard procedure.

Standard procedure: The standard procedure corresponds to the SOPs of the Clinic for Anaesthesiology and intensive care medicine. After admission to the operating room, the patient is monitored by means of a 3-channel ECG and pulse oximetry. The NIBP measurement by means of an upper arm cuff is carried out intermittently with a measurement interval of 2 minutes according to SOP (standard operating procedure) and is continued until the umbilical cord of the fetus is removed. Subsequently, a peripheral venous access is applied and 500 ml of full electrolyte solution are infused. Subsequently, the spinal anesthesia is applied in a seated position. Size-adapted 1.6 - 2.0 ml hyperbaric bupivacaine 0.5%, 0.1 mg morphine and 5 µg sufentanil are used. According to SOP, local skin infiltration with lidocaine 1% is carried out. After application of the spinal anaesthesia, the patient is positioned in a supine position with the operating table tilted 15° to the left. If the systolic blood pressure drops below 100 mmHg or by more than 20 % of the initial value, 100 µg phenylephrine is applied. After a sufficient entry into action (target height according to SOP TH4) the Caesarean section is performed. After birth, APGAR values are recorded after 1,5 and 10 minutes, and umbilical cord blood gas analysis is performed.

Study procedure: Randomisation of patients based on a randomisation list drawn up by an independent statistician in either NIBP or ClearSight group. In both groups, the above-mentioned standard procedure according to SOP and also the non-invasive continuous blood pressure measurement to improve blood pressure monitoring with the ClearSight? system, so that all patients are monitored by both monitoring systems. In the NIBP Group, anaesthetists are blinded against the ClearSight measurement. In the ClearSight group, anaesthetists are blinded against the NIBP measurement. Blinding is achieved by completely covering the measured values of the other method. (please describe in detail). The installation of the measuring sensors does not involve any risks for patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients who receive a caesarean section under spinal anaesthesia
  • Presence of the written declaration of consent
  • Age >/= 18 years
  • No participation in another prospective intervention study during participation in this study

Exclusion Criteria:

  • Symptomatic heart failure NYHA >/= III (New York Heart Association)
  • Symptomatic valve disease (stenosis/insufficiency) >/= II°
  • Liver failure CHILD >/= B
  • Acute or chronic renal impairment requiring dialysis
  • (pre-)clampsia
  • HELLP syndrome
  • current or previous alcohol or drug abuse
  • Psychiatric diseases
  • sepsis
  • side difference of the blood pressure measured during screening for vascular pathologies with blood pressure >12mmHg by means of NIBP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: NIBP-Group
NIBP will be shown, ClearSight will be covered.
EXPERIMENTAL: ClearSight-Group
ClearSight will be shown, NIBP will be covered.
Device: ClearSight
Patients in the intervention group receive management of volume and vasopressor settings according to the non-invasive ClearSight system.
Other Names:
  • non-invasive continous blood pressure measurement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time
Time Frame: duration of surgery (an average of 2 hours)
Mean difference in time to detection and treatment of hypotension between continuous non-invasive (ClearSight) blood pressure measurement and NIBP, determined by the area under the curve (AUC) of latency between hypotension and therapy.
duration of surgery (an average of 2 hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
APGAR-1
Time Frame: after delivery (an average of 1 minute)
APGAR value 1 minute after delivery
after delivery (an average of 1 minute)
APGAR-5
Time Frame: after delivery (an average of 5 minutes)
APGAR value 5 minutes after delivery
after delivery (an average of 5 minutes)
APGAR-10
Time Frame: after delivery (an average of 10 minutes)
APGAR value 10 minutes after delivery
after delivery (an average of 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sascha Treskatsch, MD, Prof, Charité

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2018

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ClearBirth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cesarean Section Complications

Clinical Trials on ClearSight

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings