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Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia (DINOCS)

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ClinicalTrials.gov Identifier: NCT02437799
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Hypotension Other: Dicrotic wave analysis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Changes in the Pulse Oximeter Waveform and Blood Pressure During Spinal Anaesthesia for Caesarean Section: an Observational Study
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Caesarean section spinal anaesthesia
Dicrotic Wave analysis of pulse oximeter of Women undergoing planned caesarean section under spinal anaesthesia.
Other: Dicrotic wave analysis
We will download data from the pulse oximeter that is being used to monitor the patient during their surgery.




Primary Outcome Measures :
  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. [ Time Frame: Data will be downloaded for approximately 20 minutes ]
    Data will be collected during planned caesarean section under spinal anaesthesia


Secondary Outcome Measures :
  1. Time course of cardiovascular changes [ Time Frame: twenty minutes ]
    1. To clearly document the time-course of cardiovascular changes and hypotension during spinal for caesarean section

  2. Preliminary cardiovascular data [ Time Frame: twenty minutes ]
    2. To provide preliminary data to characterise cardiovascular changes during hypotension

  3. Vascular behaviour [ Time Frame: twenty minutes ]
    4. To characterise changes in vascular behaviour, and to determine their time course, before and after onset of hypotension and the given treatment.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing planned caesarean section under spinal anaesthesia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437799


Locations
United Kingdom
Sheffield NHS Trust
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: ian Wrench, MBChB,FRCA Sheffield Teaching Hospitals NHS Foundation Trust

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02437799     History of Changes
Other Study ID Numbers: STH18900
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Pulse oximeter
Caesarean section
hypotension
Spinal anaesthesia

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs