Caesarean SectionNCT02285569
The Pleth Variability Index and Hypotension at Caesarean Under Spinal.
An observational study of Caesarean Section, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Caesarean Section
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients with a singleton uncomplicated pregnancy presenting for elective caesarean section under spinal anaesthesia where surgery and anaesthesia are anticipated to be uncomplicated.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Jessop Wing Hospital
Sheffield, South Yorkshire, S10 2SF
About this study
Official title: Can Changes in the Pleth Variability Index be Used to Predict Significant Hypotension During Spinal Anaesthesia for Caesarean Section?
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.
Read the detailed description
BACKGROUND: When a baby is delivered by a surgical procedure (a Caesarean Section) the women will usually have a spinal anaesthetic. With a spinal anaesthetic local anaesthetic is injected into the spinal fluid to make the woman numb from her chest to her feet and this allows her to be comfortable but awake during the birth. One of the common side effects of a spinal anaesthetic is that the woman's blood pressure may fall making her feel unwell and (rarely) causing stress to the unborn baby. 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 have used the MRS on one of their patients who was having a caesarean section under a spinal anaesthetic and the PVI was seen to change before the patients blood pressure fell. Because this was only one case they would like to try the MRS on some more patients to see if the PVI can be used to predict falls in blood pressure. To keep a close eye on the blood pressure they would use another monitor called a finometer. A finometer measures blood pressure continuously by means of a small cuff that is placed around a finger. The finometer should allow them to follow changes in blood pressure more closely and see how these affect the PVI reading.
AIMS: The aim of this study is to see whether changes in PVI happen before a fall in blood pressure when a woman is having a spinal anaesthetic for a caesarean section.
METHODOLOGY: The women will have exactly the same anaesthetic as they would have had if they were not in the study. The investigators will simply be using two pieces of equipment (the MRS and the Finometer) to see what happens when and if the blood pressure falls.
EXPECTED OUTCOMES: The investigators hope that they will find that the PVI changes before the blood pressure falls significantly.
IMPLICATIONS: If this study were to be promising then the investigators could go on to perform another study where they use the MRS to help them decide when to give drugs and intravenous fluids to stop the blood pressure from falling.
- Conditions
- Caesarean Section
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Wrench, Dr, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285569
- Sponsor's protocol ID
- STH16496
- Status last verified
- May 2015
- First submitted
- 31 Oct 2014
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Changes in the Pleth Variability Index be Used to Predict Significant Hypotension During Spinal Anaesthesia for Caesarean Section?
- ClinicalTrials.gov ID
- NCT02285569
- Acronym / sponsor ID
- STH16496
- Conditions
- Caesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND: When a baby is delivered by a surgical procedure (a Caesarean Section) the women will usually have a spinal anaesthetic. With a spinal anaesthetic local anaesthetic is injected into the spinal fluid to make the woman numb from her chest to her feet and this allows her to be comfortable but awake during the birth. One of the common side effects of a spinal anaesthetic is that the woman's blood pressure may fall making her feel unwell and (rarely) causing stress to the unborn baby. 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 have used the MRS on one of their patients who was having a caesarean section under a spinal anaesthetic and the PVI was seen to change before the patients blood pressure fell. Because this was only one case they would like to try the MRS on some more patients to see if the PVI can be used to predict falls in blood pressure. To keep a close eye on the blood pressure they would use another monitor called a finometer. A finometer measures blood pressure continuously by means of a small cuff that is placed around a finger. The finometer should allow them to follow changes in blood pressure more closely and see how these affect the PVI reading.
AIMS: The aim of this study is to see whether changes in PVI happen before a fall in blood pressure when a woman is having a spinal anaesthetic for a caesarean section.
METHODOLOGY: The women will have exactly the same anaesthetic as they would have had if they were not in the study. The investigators will simply be using two pieces of equipment (the MRS and the Finometer) to see what happens when and if the blood pressure falls.
EXPECTED OUTCOMES: The investigators hope that they will find that the PVI changes before the blood pressure falls significantly.
IMPLICATIONS: If this study were to be promising then the investigators could go on to perform another study where they use the MRS to help them decide when to give drugs and intravenous fluids to stop the blood pressure from falling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients with a singleton uncomplicated pregnancy presenting for elective caesarean section under spinal anaesthesia where surgery and anaesthesia are anticipated to be uncomplicated.
Key exclusion criteria (8 listed)
- Age under 18
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
Related trials for Caesarean Section
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Wrench, Dr principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Caesarean Section, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015.