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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• ≥ 37 weeks of gestation

• Elective CS

• Age between 18 - 40 years old

• Singleton pregnancy

• Planned for spinal anaesthesia

Locations
Other Locations
Malaysia
Hospital Canselor Tuanku Muhriz
RECRUITING
Cheras
Contact Information
Primary
Syarifah Noor Nazihah Sayed Masri
syarifahnazihah@yahoo.com.my
0133452456
Backup
Nadhirah Abdul Halim
naddyhalim90@gmail.com
+60 16-969 7554
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 100
Treatments
Experimental: Group 1: HPI Group
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.
Placebo_comparator: Group 2: NIBP Group
the attending anaesthetist will be blinded from the HPI parameters.
Related Therapeutic Areas
Sponsors
Leads: National University of Malaysia

This content was sourced from clinicaltrials.gov