Cesarean Delivery Affecting NewbornClearBirthNCT03402685
Continuous Non-invasive Blood Pressure Measurement in C-section
A study testing ClearSight in people with Cesarean Delivery Affecting Newborn and Cesarean Delivery Affecting Fetus, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery Affecting Newborn, Cesarean Delivery Affecting Fetus, Cesarean Section Complications
- What is being tested?
- ClearSight
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2018to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Delivery Affecting Newborn, Cesarean Delivery Affecting Fetus, Cesarean Section Complications
- Being tested
- ClearSight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClearSightDevice
Also called non-invasive continous blood pressure measurement
Patients in the intervention group receive management of volume and vasopressor settings according to the non-invasive ClearSight system.
| Study group | Role | What they receive |
|---|---|---|
| NIBP-Group | No intervention | NIBP will be shown, ClearSight will be covered. |
| ClearSight-Group | Experimental | ClearSight will be shown, NIBP will be covered. Receives: Device: ClearSight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
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.
Measured: duration of surgery (an average of 2 hours)
Secondary outcomes (3)
APGAR-1
APGAR value 1 minute after delivery
Measured: after delivery (an average of 1 minute)
APGAR-5
APGAR value 5 minutes after delivery
Measured: after delivery (an average of 5 minutes)
APGAR-10
APGAR value 10 minutes after delivery
Measured: after delivery (an average of 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start17 May 2018
- Primary completion31 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Affecting NewbornStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation of patients using 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Treskatsch, Charite University, Berlin, Germany
- Investigators
- Sascha Treskatsch, MD, Prof, Principal investigator, Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402685
- Sponsor's protocol ID
- ClearBirth
- Acronym
- ClearBirth
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2018
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Continuous Non-invasive Blood Pressure Measurement on Fetal Outcome After Caesarean Section ("ClearBirth")
- ClinicalTrials.gov ID
- NCT03402685
- Acronym / sponsor ID
- ClearBirth / ClearBirth
- Conditions
- Cesarean Delivery Affecting Newborn, Cesarean Delivery Affecting Fetus, Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation of patients using 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.
| Arm | Type | Receives |
|---|---|---|
| NIBP-Group | No intervention | –NIBP will be shown, ClearSight will be covered. |
| ClearSight-Group | Experimental | Device: ClearSightClearSight will be shown, NIBP will be covered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClearSightAlso: non-invasive continous blood pressure measurementPatients in the intervention group receive management of volume and vasopressor settings according to the non-invasive ClearSight system. | Device | ClearSight-Group |
Primary outcome
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.
3 secondary outcomes
APGAR-1
Time frame: after delivery (an average of 1 minute)
APGAR-5
Time frame: after delivery (an average of 5 minutes)
APGAR-10
Time frame: after delivery (an average of 10 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascha Treskatsch, MD, Prof principal investigator
Charite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClearSight in people with Cesarean Delivery Affecting Newborn and Cesarean Delivery Affecting Fetus, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: duration of surgery (an average of 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.