Clinical trial NCT06892665: The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections
Official title: The Effect Of Using Hypotension Prediction Index To Reduce Intraoperative Hypotension In Caesarean Sections: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Hypotension
Maternal-Fetal Relations
Cesarean Section Complications
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, double-blinded, randomised controlled trial
Primary purpose: PREVENTION

Brief summary: During caesarean section, blood pressure variations especially a reduction in blood pressure (or hypotension) can bring harmful effects to mother and baby. This usually occurs after spinal anaesthesia is administered. Usually, the anaesthetist will treat hypotension as it occurs. However, a new medical device is now available to predict hypotension. It is called the Hypotension Prediction Index (HPI). This device allows the prediction of hypotension; hence, treatment can be given before it occurs. It has been widely utilised in major surgeries like abdominal tumour surgery and cardiac surgery worldwide and has shown a substantial reduction in hypotension. This study aims to determine whether the duration and severity of hypotension can be reduced when HPI is used in lower segment caesarean sections. The secondary objective of the study is to determine if the complication rate can be reduced in both mother and baby.

Detailed description: Hypotension Prediction Index (HPI) has been shown to reduce IOH significantly in non-cardiac and major abdominal surgeries.The role of HPI beyond reducing IOH has also been a subject of research. Andrzejeska et al. demonstrated that the use of HPI in adolescent idiopathic scoliosis surgery leads to lower reductions in post-surgery haemoglobin levels, shorter duration of hypotension and shorter hospital admissions. Additionally, the intervention group had shorter timeframes from the end of surgery to extubation.

The development of a non-invasive finger blood pressure device compatible with HPI called the Acumen IQ cuff, made it possible to use HPI without inserting an arterial catheter. The arterial pressure waveform generated by a non-invasive finger cuff was reliable and in agreement with the radial artery blood pressure. A retrospective analysis was conducted by Frassanito et al. to determine the performance of HPI using arterial waveform recorded by a non-invasive finger probe to predict hypotension in patients undergoing CS under spinal anaesthesia. They have found that HPI, using this non-invasive probe, was able to predict hypotension with a sensitivity and specificity of 83% and 83% at 3 minutes, 97% and 97% at 2 minutes, and 100% and 100% at 1 minute, before it occurs.

This study aims to determine if the solution to reduce IOH lies in predicting intraoperative hypotension during lower segment ceaserean section (CS). The benefits of HPI may extend beyond reducing the incidence and severity of IOH, to bringing positive outcomes to the foetus. This study will determine whether integrating an early warning system produces benefits significant enough to justify changing our anaesthetic practice.

PROBLEM STATEMENT

Varying methods have been utilised to reduce IOH in CS. A novel software, HPI, was developed to predict hypotension, enabling clinicians to institute guided treatment before maternal hypotension occurs. The investigator need to determine if HPI has benefits in CS, thus leading to better maternal and neonatal outcomes.

RESEARCH QUESTION

Can HPI using the non-invasive continuous arterial pressure waveforms reduce the duration and severity of hypotension in patients undergoing CS under spinal anaesthesia?

OBJECTIVES

Study objective:

To determine if HPI has benefits in CS, thus leading to better maternal and neonatal outcomes compared to oNIBP.

Primary outcome:

The duration and severity of hypotensive events reported as a time-weighted average (TWA) - MAP \< 65 mmHg in HPI group (intervention) versus standard oNIBP.

Secondary outcomes:

1. To determine whether the use of HPI leads to better maternal outcomes (incidence of nausea and vomiting, blood loss, length of hospital stay, maternal satisfaction, incidence of surgical site infection)
2. To determine whether the use of HPI leads to better foetal outcomes (Apgar scores, umbilical cord pH, length of hospital stay)
3. To determine the amount of vasopressors and inotropes administered throughout CS if HPI is used versus conventional oNIBP monitoring

RESEARCH HYPOTHESIS

Additional parameters from HPI in the CS under spinal anaesthesia will reduce the duration and severity of intraoperative hypotension and provide better maternal and neonatal outcomes.

Eligibility criteria: Inclusion criteria:

* ≥ 37 weeks of gestation
* Elective CS
* Age between 18 - 40 years old
* Singleton pregnancy
* Planned for spinal anaesthesia

Exclusion criteria:

* American Society of Anesthesiologists (ASA) III and above
* Body mass index (BMI) ≥ 40 kg/m2
* Increased risk of developing peripartum haemorrhage
* History of peripartum haemorrhage
* Placenta previa major, accrete, increta, percreta
* Gravida ≥ 5
* Presence of large uterine fibroids
* Congenital bleeding disorders such as Haemophilia A, Haemophilia B and Von Willebrand disease
* Acquired bleeding disorders such as thrombocytopenia and coagulopathy
* Contraindications to finger cuff orNIBP application, such as finger ischaemia, upper limb neurological deficit, discoloured nail
* Cardiac arrhythmias and aortic regurgitation
* Patient's refusal

Primary outcomes:
measure: Time-weighted average of Mean arterial pressure <65mmHg
timeFrame: From spinal anaesthesia to completion of surgery
Secondary outcomes:
measure: Incidence of nausea and vomiting,
timeFrame: Perioperative up to 2 days
measure: length of hospital stay
timeFrame: Perioperative up to 2 weeks
measure: maternal satisfaction
timeFrame: Perioperative up to 2 weeks
measure: incidence of surgical site infection
timeFrame: Perioperative up to 2 weeks
measure: Apgar score of feotal
timeFrame: 1 minute and 5 minutes after delivery
measure: Umbilical cord PH
timeFrame: Immediately upon delivery of baby
measure: Neonatal length of stay
timeFrame: Perioperative up to 2 weeks
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Hospital Canselor Tuanku Muhriz
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: National University of Malaysia
name: Azlina Masdar
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murabito P, Astuto M, Sanfilippo F, La Via L, Vasile F, Basile F, Cappellani A, Longhitano L, Distefano A, Li Volti G. Proactive Management of Intraoperative Hypotension Reduces Biomarkers of Organ Injury and Oxidative Stress during Elective Non-Cardiac Surgery: A Pilot Randomized Controlled Trial. J Clin Med. 2022 Jan 13;11(2):392. doi: 10.3390/jcm11020392.
citation: Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
citation: Frassanito L, Sonnino C, Piersanti A, Zanfini BA, Catarci S, Giuri PP, Scorzoni M, Gonnella GL, Antonelli M, Draisci G. Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia. Anesth Analg. 2022 Mar 1;134(3):633-643. doi: 10.1213/ANE.0000000000005754.
citation: Andrzejewska A, Miegon J, Zacha S, Skonieczna-Zydecka K, Jarosz K, Zacha W, Biernawska J. The Impact of Intraoperative Haemodynamic Monitoring, Prediction of Hypotension and Goal-Directed Therapy on the Outcomes of Patients Treated with Posterior Fusion Due to Adolescent Idiopathic Scoliosis. J Clin Med. 2023 Jul 9;12(14):4571. doi: 10.3390/jcm12144571.