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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
100
HPI and other haemodynamics parameters, is available to the anaesthetist to view and act upon
Anaesthetist will respond to hemodynamic variables using NIBP
Hospital Canselor Tuanku Muhriz
Cheras, Kuala Lumpur, Malaysia
RECRUITINGTime-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))
Time frame: From spinal anaesthesia to completion of surgery
Incidence of nausea and vomiting,
Maternal incidence of nausea and vomiting
Time frame: Perioperative up to 2 days
length of hospital stay
maternal length of hospital stay
Time frame: Perioperative up to 2 weeks
maternal satisfaction
Likert scale from 1 (very unsatisfied) to 5 (very satisfied)
Time frame: Perioperative up to 2 weeks
incidence of surgical site infection
maternal surgical site infection
Time frame: Perioperative up to 2 weeks
Apgar score of feotal
Apgar scores of 0-10 ( Apgar score of 7 and more is considered normal)
Time frame: 1 minute and 5 minutes after delivery
Umbilical cord PH
Umbilical cord PH taken after after delivery of baby
Time frame: Immediately upon delivery of baby
Neonatal length of stay
Neonatal length of stay
Time frame: Perioperative up to 2 weeks
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