Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

NCT03620942 | Active Not Recruiting

• 1 other identifier: SHF/CTG061/2017
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal hypotension during spinal anaesthesia for Caesarean delivery may bring various adverse effects. It is therefore important to closely monitor hypotension during spinal anaesthesia, however current technology does not allow the blood pressure monitoring to respond in timely manner should there be any occurrence of hypotension. The investigators developed an advanced double-intravenous vasopressor automated system (ADIVA) so as to tackle this issue via novel algorithm to control blood pressure more rigorously with more stable haemodynamic profiles.

Conditions

Hypotension; Anesthesia

Keywords

Maternal hypotension; Spinal anaesthesia; Caesarean section

Outcome Measures

Primary Outcomes (1)

• Number of events of Hypotension occurrence

  Systolic blood pressure less than 80% of baseline systolic blood pressure

  1 day (during cesarean delivery)

Secondary Outcomes (2)

• Number of events of Hypertension occurrence

  1 day (during cesarean delivery)

• Number of events of Nausea and vomiting occurrence

  1 day (during and after cesarean delivery)

Study Arms (2)

ADIVA system

EXPERIMENTAL

Vasopressor delivery automated system administering phenylephrine and ephedrine using a three-step algorithm vasopressor delivery technique

Drug: Phenylephrine; Drug: Ephedrine; Device: ADIVA System

DIVA system

ACTIVE COMPARATOR

Vasopressor delivery automated system administering phenylephrine and ephedrine using a two-step algorithm vasopressor delivery technique

Drug: Phenylephrine; Drug: Ephedrine; Device: DIVA System

Interventions

Phenylephrine DRUG

Phenylephrine will be administered with conditions as below: 1. When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min; 2. When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min.

Also known as: Vasopressor

ADIVA system; DIVA system

Ephedrine DRUG

Ephedrine will be administered with conditions as below: 1. When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate \< 60 beats/min; 2. When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate \< 60 beats/min.

Also known as: Vasopressor

ADIVA system; DIVA system

ADIVA System DEVICE

1. When systolic blood pressure (SBP) is 100-110% of baseline, 25mcg phenylephrine (infusion) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion) is given if heart rate \< 60 beats/min; 2. When SBP is 90-100% of baseline, 25mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion or bolus) is given if heart rate \< 60 beats/min; 3. When SBP is 80-90% of baseline, 50mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 4mg ephedrine (infusion or bolus) is given if heart rate \< 60 beats/min; 4. When SBP \< 80% of baseline, 75mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 6mg ephedrine (infusion or bolus) is given if heart rate \< 60 beats/min.

Also known as: Advanced Double Intravenous Vasopressor Automated System

ADIVA system

DIVA System DEVICE

DIVA system works as below: 1. When systolic blood pressure is between 90 to 100% of baseline, 25mcg phenylephrine (bolus) will be given if heart rate ≥ 60 beats/min, whereas 2mg ephedrine (bolus) will be given if heart rate \< 60 beats/min; 2. When systolic blood pressure is less than 90% of baseline, 50mcg phenylephrine (infusion or bolus) will be given if heart rate ≥ 60 beats/min, whereas 4mg ephedrine (infusion or bolus) will be given if heart rate \< 60 beats/min.

Also known as: Double Intravenous Vasopressor Automated System

DIVA system

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Only female patients undergoing cesarean delivery will be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients;
• With singleton full-term pregnancy;
• The indication for an elective cesarean delivery;
• The use of spinal anaesthesia for cesarean delivery;
• Anthropometric profile within the following range: age 21-50 years old, weight 40-90 kg and height of 145-170 cm.

You may not qualify if:

• Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
• Contraindication to spinal anaesthesia and/or allergy to opioids.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (2)

• Tan HS, Nagarajan S, Chan JJI, Tan CW, Sultana R, Sia ATH, Sng BL. Evaluating an advanced double intravenous vasopressor automated system to treat hypotension during spinal anesthesia for cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2023 Jan 26;23(1):33. doi: 10.1186/s12871-023-01992-7.

  PMID: 36703120 DERIVED

• Nagarajan S, Chan JJI, Tan CW, Al-Hashim ZGA, Sultana R, Sia ATH, Sng BL. An advanced double intravenous vasopressor automated system to treat hypotension during spinal anaesthesia for caesarean section: A pilot study. Eur J Anaesthesiol. 2022 Jan 1;39(1):42-49. doi: 10.1097/EJA.0000000000001496.

  PMID: 33831901 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Phenylephrine; Vasoconstrictor Agents; Ephedrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Propanolamines; Propanols; Phenethylamines; Ethylamines

Study Officials

• Singaraselvan Nagarajan, FCARCSI

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The first phase recruited 76 parturients. The second phase recruited 97 parturients. Parturients recruited from this phase will be randomized into either ADIVA group or DIVA group.

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 8, 2018
• Study Start: November 7, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)