An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study.

BACKGROUND

During spinal anaesthesia for caesarean section, haemodynamic instability may lead to maternal and foetal complications. We developed a novel advanced double intravenous vasopressor automated system (ADIVA) by using a continuous blood pressure and heart rate monitor. Treatment of hypotension was based on three criteria: the drug (phenylephrine or ephedrine) according to the heart rate; the dose of vasopressor determined by the degree of hypotension; a fast or slow bolus of vasopressor administered depending on whether there was a negative or positive gradient of SBP changes, respectively.

OBJECTIVE

The aim of this pilot study was to investigate the feasibility of the ADIVA algorithm.

DESIGN

A prospective pilot study.

SETTING

Single obstetrics and gynaecology centre in Singapore.

PATIENTS

Women undergoing elective caesarean delivery under spinal anaesthesia.

INTERVENTION

Automated administration of ephedrine or phenylephrine based on changes in blood pressure and heart rate (via the ADIVA algorithm) detected on continuous noninvasive haemodynamic monitoring using noninvasive continuous haemodynamic monitor (Nexfin).

MAIN OUTCOME MEASURES

The primary outcome was the incidence of hypotension, defined as SBP less than 80% of baseline. The secondary outcome measures were reactive hypertension, total vasopressor requirement, maternal and neonatal outcomes and system performance.

RESULTS

Forty-five women were recruited. Thirty-one women (69.9%) had at least one reading of hypotension. SBP was within ±20% of the baseline in a mean ± SD of 79.7 ± 17.6% of measurements. Forty-four (97.8%) women required phenylephrine before delivery, while 15 (33.3%) required ephedrine. No rescue medications were required. Three women (6.7%) had nausea and two (4.4%) vomiting. All neonates had APGAR scores of 9 at 5 min.

CONCLUSION

The ADIVA system, with noninvasive continuous haemodynamic monitoring, was able to maintain maternal SBP within ±20% of baseline for the vast majority of the measurements. This system had good maternal and foetal outcomes with minimal intervention from the attending anaesthetist.

TRIAL REGISTRATION

NCT03620942.