A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

Hypotension Clinical Trial

— DIVA  

Official title:

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277730
• Other study ID #: SHF/CTG047/2012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 26, 2014
• Last updated: March 7, 2018
• Start date: May 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. The investigators developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using NexfinTM with a two-step algorithm.

Description:

Hypotension occurs commonly during spinal anaesthesia for caesarean section with maternal and fetal adverse effects. We developed a double-vasopressor automated system incorporating continuous non-invasive haemodynamic monitoring using Nexfin cardiac output monitor with a two-step algorithm. The system delivered phenylephrine 25 mcg or ephedrine 2 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 50 mcg or ephedrine 4 mg (if heart rate<60 beats.min-1) every 30 seconds when systolic blood pressure was <90% of baseline.

A randomised controlled trial will be done to compare with manual bolus technique. With the manual bolus technique, phenylephrine 50mcg or ephedrine 4mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was between 90-100% of baseline. The system delivered phenylephrine 100mcg or ephedrine 8mg (if heart rate<60 beats.min-1) every 60 seconds when systolic blood pressure was <90% of baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• age 21-45 years old,

• weight 40-90 kg,

• height 145-170 cm

Exclusion Criteria:

• contraindications to spinal anaesthesia,

• allergy to drugs used in the study, and

• those with uncontrolled medical conditions such as hypertension, diabetes mellitus, and cardiovascular disease

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• vasopressor delivery automated system
vasopressor delivery using phenylephrine and ephedrine

Drug:
• phenylephrine

• ephedrine

Device:
• manual vasopressor delivery

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	Systolic blood pressure less than 80% of baseline systolic blood pressure	1 day
Secondary	Hypertension	Systolic blood pressure more than 120% of baseline systolic blood pressure	1 day
Secondary	Nausea and vomiting	Nausea and vomiting during Caesarean section	1 day