Supine Hypotensive SyndromeNCT05341362
Hemodynamic Management in Women With SHS
A study testing LiDCOrapid in people with Supine Hypotensive Syndrome, run by China Medical University, China at 1 site in China.
Trial summary
Supine hypotensive syndrome often occurs following spinal anesthesia for cesarean delivery.In our study we base the regulation and drug administration both on the regular monitor and on a novel monitor which reflects upon the hemodynamic changes. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Supine Hypotensive Syndrome
- What is being tested?
- LiDCOrapid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2022to 1 Jun 2023
- Phase
- Interventional
- 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 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) Physical Status Classification II and had no significant cardiovascular, pulmonary, renal or endocrine disease, without contraindications to CSEA,and could be diagnosed as SHS according to the criteria.
Who cannot join
- Patients undergoing emergency CD, CD under general anesthesia or patients' refusal to participate, or multiple fetations.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Medical University
Shenyang, Liaoning, 110000
Li Yuqing, 86-15942019671
About this study
Official title: Hemodynamic Management Target on Continuous Monitoring in Cesarean Delivery-A Randomized Controlled Trial in Patients With Supine Hypotensive Syndrome
Supine hypotensive syndrome often occurs following spinal anesthesia for cesarean delivery.In our study we base the regulation and drug administration both on the regular monitor and on a novel monitor which reflects upon the hemodynamic changes. Our aim is to observe whether the outcome of SHS patients with anesthesia management based on hemodynamic figures differs from those based on experience.
- Conditions
- Supine Hypotensive Syndrome
- Being tested
- LiDCOrapid
- Keywords
- supine hypotensive syndrome, cesarean delivery, spinal anesthesia, CSEA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiDCOrapidProcedure or surgery
According to the illustration of the patient's hemodynamic figures shown on the LiDCOrapid monitor, we decide on the timing of the vasopressor administration. This group aims to maintain the cardiac output within a baseline range.
| Study group | Role | What they receive |
|---|---|---|
| Blank Group | No intervention | In this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor. |
| LiDCOrapid Group | Experimental | In this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid. Receives: Procedure: LiDCOrapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical arterial blood gas PH
The value is tested immediately after the blood sample is achieved after the infant is born.
Measured: 30minutes
Secondary outcomes (4)
Discomfort Score
we explored a scoring system to quantify the SHS symptom scale from 0 to 8, score high means more symptoms of SHS occurred
Measured: 1day
total vasopressor dosage
total vasopressor given during the time span between the operation began to the baby was delivered
Measured: 30 minutes
Umbilical blood gas lactate
The value is tested immediately after the blood sample is achieved after the infant is born.
Measured: 30minutes
Time span
the period between the operation began to the baby was delivered
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start17 Apr 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supine Hypotensive SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuqing Li, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341362
- Sponsor's protocol ID
- SHSandLidco
- Status last verified
- Mar 2023
- First submitted
- 10 Apr 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Management Target on Continuous Monitoring in Cesarean Delivery-A Randomized Controlled Trial in Patients With Supine Hypotensive Syndrome
- ClinicalTrials.gov ID
- NCT05341362
- Acronym / sponsor ID
- SHSandLidco
- Conditions
- Supine Hypotensive Syndrome
- Keywords
- supine hypotensive syndrome, cesarean delivery, spinal anesthesia, CSEA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 17 Apr 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 Apr 2022 (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.
Supine hypotensive syndrome often occurs following spinal anesthesia for cesarean delivery.In our study we base the regulation and drug administration both on the regular monitor and on a novel monitor which reflects upon the hemodynamic changes. Our aim is to observe whether the outcome of SHS patients with anesthesia management based on hemodynamic figures differs from those based on experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blank Group | No intervention | –In this group, the anesthesia management is conducted according to the anesthetists' experience, based on the regular monitor. |
| LiDCOrapid Group | Experimental | Procedure: LiDCOrapidIn this group, the anesthesia management is conducted based on both the regular monitor and the hemodynamic figures on the LiDCOrapid. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) Physical Status Classification II and had no significant cardiovascular, pulmonary, renal or endocrine disease, without contraindications to CSEA,and could be diagnosed as SHS according to the criteria.
Key exclusion criteria (1 listed)
- Patients undergoing emergency CD, CD under general anesthesia or patients' refusal to participate, or multiple fetations.
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 |
|---|---|---|
| LiDCOrapidAccording to the illustration of the patient's hemodynamic figures shown on the LiDCOrapid monitor, we decide on the timing of the vasopressor administration. This group aims to maintain the cardiac output within a baseline range. | Procedure or surgery | LiDCOrapid Group |
Primary outcome
Umbilical arterial blood gas PH
Time frame: 30minutes
The value is tested immediately after the blood sample is achieved after the infant is born.
4 secondary outcomes
Discomfort Score
Time frame: 1day
total vasopressor dosage
Time frame: 30 minutes
Umbilical blood gas lactate
Time frame: 30minutes
Time span
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiDCOrapid in people with Supine Hypotensive Syndrome, run by China Medical University, China at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yuqing (86-15942019671, liyuqing1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Umbilical arterial blood gas PH (time frame: 30minutes). 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 7 Mar 2023.