RecruitingNot ApplicableNCT06892665

The Effect of HPI to Reduce Intraoperative Hypotension in Caesarean Sections

The Effect Of Using Hypotension Prediction Index To Reduce Intraoperative Hypotension In Caesarean Sections: A Randomised Controlled Trial


Sponsor

National University of Malaysia

Enrollment

100 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria5

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

Exclusion Criteria12

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHypotension prediction index

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

DEVICENon invasive Blood Pressure Monitoring

Anaesthetist will respond to hemodynamic variables using NIBP


Locations(1)

Hospital Canselor Tuanku Muhriz

Cheras, Kuala Lumpur, Malaysia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06892665


Related Trials