The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

NCT06892665 | Recruiting DMC

• 1 other identifier: JEP-2024-463
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Hypotension; Maternal-Fetal Relations; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Time-weighted average of Mean arterial pressure <65mmHg

  Calculated using a formula. TWA-MAP \< 65 mmHg = (the depth of hypotension\< MAP of 65 mmHg x time spent below a MAP of 65 mmHg (minutes))/(total duration of operation (minutes))

  From spinal anaesthesia to completion of surgery

Secondary Outcomes (7)

• Incidence of nausea and vomiting,

  Perioperative up to 2 days

• length of hospital stay

  Perioperative up to 2 weeks

• maternal satisfaction

  Perioperative up to 2 weeks

• incidence of surgical site infection

  Perioperative up to 2 weeks

• Apgar score of feotal

  1 minute and 5 minutes after delivery

Study Arms (2)

Group 1: HPI Group

EXPERIMENTAL

There were 2 arm group, in Group 1the Acumen IQ cuff, with HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon.

Device: Hypotension prediction index

Group 2: NIBP Group

PLACEBO COMPARATOR

the attending anaesthetist will be blinded from the HPI parameters.

Device: Non invasive Blood Pressure Monitoring

Interventions

Hypotension prediction index DEVICE

HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon

Also known as: HPI

Group 1: HPI Group

Non invasive Blood Pressure Monitoring DEVICE

Anaesthetist will respond to hemodynamic variables using NIBP

Also known as: NIBP

Group 2: NIBP Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Parturients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

Related Publications (4)

• 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.

  PMID: 35054083 BACKGROUND

• 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.

  PMID: 26181335 BACKGROUND

• 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.

  PMID: 34591796 BACKGROUND

• 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.

  PMID: 37510686 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Azlina Masdar

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Syarifah Noor Nazihah Sayed Masri

CONTACT

0133452456; syarifahnazihah@yahoo.com.my

Nadhirah Abdul Halim

CONTACT

+60 16-969 7554; naddyhalim90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: By computer randomisation, patients will be randomised into two groups, Group A (Intervention: HPI) or Group B (control: oNIBP). Standard monitoring will be applied, including a 3-lead electrocardiogram, pulse oximetry, and oNIBP in the upper arm. The oNIBP monitoring will be performed every 1 minute before, and every 3 minutes after the baby is delivered, up to 90 minutes of surgery duration. After 90 minutes, data collection will cease. In addition to the standard monitoring, all patients will have an Acumen IQ cuff placed on one of their fingers, as Appendix A shows, connected to haemodynamic monitoring using HemoSphere (Edwards Lifesciences) with HPI software enabled. In Group A, the Acumen IQ cuff, with HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon. While in Group B, the attending anaesthetist will be blinded from the HPI parameters.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, double-blinded, randomised controlled trial

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 25, 2025
• Study Start: January 1, 2025
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After completion of the study and analysis for 5 years
• Access Criteria: With permission from corresponding author

Locations

MY (1)