Comparative Study of Haemodynamic Changes After Spinal Anaesthesia in Non-obese and Pregnant Women

NCT02599376 | Completed

• 1 other identifier: 1/028/14
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity has become one of the most common risk factors in obstetric practice with serious anaesthetic implications. Obese pregnants have limited physiological reserves and cardiovascular co- morbidities when compared to non-obese pregnant women. Spinal anaesthesia is the anaesthetic technique of choice for caesarean section. The haemodynamic changes associated with spinal anaesthesia pose the greatest hazard to the mother and the foetus and are exaggerated in obese pregnant women. However differences in the changes in haemodynamic variables such as cardiac output (CO), stroke volume (SV) and systemic vascular resistance (SVR) between obese and non-obese pregnant women having caesarean section (CS) under spinal anaesthesia have not been studied before. This study compares the haemodynamic changes after spinal anaesthesia for CS in non-obese and obese parturients in a single centre, prospective case control study, using LiDCOrapidV2. This LiDCOrapidV2 device is a noninvasive method of measuring haemodynamic variables. It is a single centre, prospective, case control study. The primary outcome compares the differences and variability in CO, SV and SVR between obese and non-obese parturients. The secondary outcomes include comparison of the correlation between changes in blood pressure (BP) and CO in each patient and the difference in BP between conventional intermittent oscillometric device and continuous LiDCORapidV2in each patient with a view to assess the need for measurement of cardiac output in obstetric anaesthesia

Conditions

Low Cardiac Output

Outcome Measures

Primary Outcomes (1)

• Difference in the variation of cardiac output (CO) from baseline values between obese and non-obese parturients after spinal anaesthesia.

  The change in cardiac output from baseline measured as milliliters/minute at predetermined intervals after spinal anaesthesia will be recorded in each group. The mean value of this change in each group will be compared for each recording and the difference in the change between the two groups will be reported.

  18 months

Secondary Outcomes (1)

• Mean difference in the amount of vasopressors infused in millilitres/hour between non-obese and obese pregnant women.

  12 months

Study Arms (2)

BMI less than 30

ACTIVE COMPARATOR

The drop in cardiac output after spinal anaesthesia for LSCS at various intervals with LiDCORapid

Device: LiDCOrapid

BMI more than 40

EXPERIMENTAL

The drop in cardiac output after spinal anaesthesia for LSCS at various intervals with LiDCORapid

Device: LiDCOrapid

Interventions

LiDCOrapid DEVICE

Cardiac output will be non invasively monitored by using 2 cuffs on fingers.

BMI less than 30; BMI more than 40

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant patients with BMI of less than 30 undergoing elective CS.
• Obese pregnant patients with BMI of more than 35 undergoing elective CS

You may not qualify if:

• Patients with other comorbidities like pre-eclampsia, eclampsia, essential hypertension, respiratory disease and compromised renal function.
• Patients on long-term medication.
• Patients having CS under epidural.
• Patients having general anaesthesia.
• Patients on antihypertensive medication.
• Patients with BMI of 31-34.
• Patients less than 36 weeks of gestation

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Aberdeen Maternity Hospital

Aberdeen, Aberdeen, AB25 2ZN, United Kingdom

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manisha Kumar, FRCA

  NHS Grampian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: November 6, 2015
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)