The Pleth Variability Index and Hypotension at Caesarean Under Spinal.

NCT02285569 | Completed

• 1 other identifier: STH16496
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

During a caesarean section the blood pressure is usually measured every few minutes and it may fall too quickly to be detected in a timely fashion by this intermittent means. The monitor the Masimo Rainbow SET® (MRS) uses a peg attached to a finger to detect (amongst other things) the flow of blood through it. One of the measures it takes is called the Pleth Variability Index (PVI) which (unlike standard blood pressure measurement) it measures continuously. The investigators would like to try the MRS on patients to see if the PVI can be used to predict falls in blood pressure.

Conditions

Caesarean Section

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the Pleth Variability Index change prior to a 20% fall in systolic blood pressure during spinal anaesthesia for a caesarean section.

  intraoperative

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a singleton uncomplicated pregnancy presenting for elective caesarean section under spinal anaesthesia where surgery and anaesthesia are anticipated to be uncomplicated.

You may qualify if:

• Patients with a singleton uncomplicated pregnancy presenting for elective caesarean section under spinal anaesthesia where surgery and anaesthesia are anticipated to be uncomplicated.

You may not qualify if:

• Age under 18
• Conditions which may impair the ability of the technology to read accurately such as:
• Reduced peripheral perfusion e.g. Raynaud's phenomenon
• Circulating pigments e.g. bilirubin
• Nail varnish that cannot be removed
• Diseases of pregnancy: e.g. pregnancy induced hypertension
• Significant coexisting maternal disease - e.g. congenital heart disease
• Inability to speak fluent English

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Jessop Wing Hospital

Sheffield, South Yorkshire, S10 2SF, United Kingdom

Location

Study Officials

• Ian Wrench, Dr

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 7, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

GB (1)