HypotensionNCT04608227
Non-invasive Haemodynamic Monitoring to Predict Spinal Hypotension During Caesarian Section
An observational study of Hypotension and Pregnancy Related, run by Hospital Nord at 1 site in France.
Trial summary
Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases. Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45°… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hypotension, Pregnancy Related, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Clearsight monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 15 Feb 2021
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for elective ceasarean section
Who may be able to join
- third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia
Who cannot join
- emergent ceasarean section
- eclampsia or pre-eclampsia
- undergoing anti-hypertensive treatment
- arythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study
Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.
Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.
- Conditions
- Hypotension, Pregnancy Related, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- Being tested
- Clearsight monitoring
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearsight monitoringDevice
Also called Cardiac ultrasound
Non invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge.
| Study group | Role | What they receive |
|---|---|---|
| Third trimester pregnant women undergoing ceasarean section | Not described Receives: Device: Clearsight monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Ejection volume (mL)
Systolic ejection volume is measured using Clearsight (non invasive monitoring device)
Measured: 30 minutes
Secondary outcomes (1)
Velocity - Time - Integral (cm)
Velocity - Time - Integral is measured using transthoracic cardiac ultrasound
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jun 2020
- Primary completion26 Nov 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary DUCLOS, Hospital Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608227
- Sponsor's protocol ID
- Darnord-2020
- Status last verified
- Aug 2022
- First submitted
- 19 Oct 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04608227
- Acronym / sponsor ID
- Darnord-2020
- Conditions
- Hypotension, Pregnancy Related, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital NordUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 29 Oct 2020 (actual)
- 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.
Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.
Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Third trimester pregnant women undergoing ceasarean section | – | Device: Clearsight monitoring |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for elective ceasarean section
Key inclusion criteria (1 listed)
- third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia
Key exclusion criteria (4 listed)
- emergent ceasarean section
- eclampsia or pre-eclampsia
- undergoing anti-hypertensive treatment
- arythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clearsight monitoringAlso: Cardiac ultrasoundNon invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge. | Device | Third trimester pregnant women undergoing ceasarean section |
Primary outcome
Systolic Ejection volume (mL)
Time frame: 30 minutes
Systolic ejection volume is measured using Clearsight (non invasive monitoring device)
1 secondary outcome
Velocity - Time - Integral (cm)
Time frame: 30 minutes
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 4 Aug 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypotension and Pregnancy Related, run by Hospital Nord at 1 site in France.
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 4 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 4 Aug 2022. 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 France. 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?
Systolic Ejection volume (mL) (time frame: 30 minutes). 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 4 Aug 2022.