NCT02437799

Brief Summary

BACKGROUND: Hypotension occurs commonly during spinal anaesthesia for caesarean section and may result in detrimental effects to the mother and foetus. A previous pilot study where images of the pulse oximeter waveform study were taken, found that the dicrotic wave moved away from the systolic wave during the onset of hypotension. AIMS: The investigators wish to download electronic data which describe the pulse oximeter pulse wave to more accurately assess movement of the diastolic wave relative to the systolic wave during spinal anaesthesia for caesarean section. METHODOLOGY: 20 women undergoing caesarean section under spinal anaesthesia will be recruited by informed consent for this observational study. Data downloaded from the pulse oximeter will be analysed to identify movement of the dicrotic wave relative to the systolic wave and this will be related to changes in blood pressure. EXPECTED OUTCOMES: The investigators will establish best way to analyse changes in the pulse oximeter waveform and the relationship between changes in pulse oximeter waveform morphology and the onset of hypotension during spinal anaesthesia for caesarean section. IMPLICATIONS: Analysis of movement of the dicrotic wave could be used to anticipate and thus avoid severe hypotension during spinal anaesthesia for caesarean section.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

April 1, 2015

Last Update Submit

October 12, 2016

Conditions

Hypotension

Keywords

Pulse oximeterCaesarean sectionhypotensionSpinal anaesthesia

Outcome Measures

Primary Outcomes (1)

  • 1. To download electronic data which describe the pulse oximeter pulse wave to accurately assess movement of the diastolic wave relative to the systolic wave during spinal anaesthesia for caesarean section.

    Data will be collected during planned caesarean section under spinal anaesthesia

    Data will be downloaded for approximately 20 minutes

Secondary Outcomes (3)

  • Time course of cardiovascular changes

    twenty minutes

  • Preliminary cardiovascular data

    twenty minutes

  • Vascular behaviour

    twenty minutes

Study Arms (1)

Caesarean section spinal anaesthesia

Dicrotic Wave analysis of pulse oximeter of Women undergoing planned caesarean section under spinal anaesthesia.

Other: Dicrotic wave analysis

Interventions

Dicrotic wave analysisOTHER

We will download data from the pulse oximeter that is being used to monitor the patient during their surgery.

Caesarean section spinal anaesthesia

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing planned caesarean section under spinal anaesthesia

You may qualify if:

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

You may not qualify if:

  • 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 co-existing maternal disease - e.g. congenital heart disease Inability to speak fluent English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield NHS Trust

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • ian Wrench, MBChB,FRCA

    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

April 1, 2015

First Posted

May 8, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

GB(1)