Continuous Non-invasive Blood Pressure Measurement in C-section

NCT03402685 | Completed DMC

• 1 other identifier: ClearBirth
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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%. 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.

Conditions

Cesarean Delivery Affecting Newborn; Cesarean Delivery Affecting Fetus; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• 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.

  duration of surgery (an average of 2 hours)

Secondary Outcomes (3)

• APGAR-1

  after delivery (an average of 1 minute)

• APGAR-5

  after delivery (an average of 5 minutes)

• APGAR-10

  after delivery (an average of 10 minutes)

Study Arms (2)

NIBP-Group

NO INTERVENTION

NIBP will be shown, ClearSight will be covered.

ClearSight-Group

EXPERIMENTAL

ClearSight will be shown, NIBP will be covered.

Device: ClearSight

Interventions

ClearSight DEVICE

Patients in the intervention group receive management of volume and vasopressor settings according to the non-invasive ClearSight system.

Also known as: non-invasive continous blood pressure measurement

ClearSight-Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Study Officials

• Sascha Treskatsch, MD, Prof

  Charite

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician is not informed about the group names, the APGAR scores are awarded by independent neonatologists/pediatricians and gynaecologists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy head of department Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK; MD; PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: May 17, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)