Post Spinal HypotensionCesareanNCT05120258
Can Subclavian / Infraclavicular Axillary Vein Collapsibility Index Predict Post-Spinal Hypotension in Caesarean Section Operations?
An observational study of Post Spinal Hypotension, run by Selcuk University.
Trial summary
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Post Spinal Hypotension
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2021to 2 Mar 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: ASA I-II physical status patients scheduled for cesarean section under spinal anesthesia
Who may be able to join
- Spinal anesthesia
- ceserean operation
- American Society of Anesthesiologists' (ASA) physical status I-II
Who cannot join
- Patients who underwent cesarean section in emergency conditions
- Patients who underwent cesarean section under general anesthesia
- American Society of Anesthesiologists' (ASA) physical status III-IV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Subclavian / Infraclavicular Axillary Vein Collapsibility Index in Pregnant Patients
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4).
One of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7).
In this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.
- Conditions
- Post Spinal Hypotension
- Keywords
- post spinal hypotension, the subclavian vein or infraclavicular axillary vein collapsibility index
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of Subclavian / Infraclavicular Axillary Vein Collapsibility Index for detecting Postspinal hypotension
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. This incidence is higher in pregnant women with a rate of 70%. Measurement of the IVC diameter and its collapsibility index before spinal anaesthesia has been shown to be a good predictive value of the occurrence of PSH. A previous study showed an acceptable correlation between the collapsibility of SCV (SCV-CI) and collapsibility of IVC (IVC-CI) in surgical and intensive care patients. In this study, we measured the preoperative collapsibility index of the SCV or the infraclavicular axillary vein during respiratory variation, and then examined whether these parameters could predict hypotension after spinal anaesthesia in patients undergoing ceserean
Measured: 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start8 Nov 2021 (estimated)
- Primary completion24 Jan 2022 (estimated)
- Study completion2 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE ASLANLAR, Selcuk University
- Investigators
- Emine ASLANLAR, assis. prof., Principal investigator, selcuk univercity medical faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120258
- Sponsor's protocol ID
- SCV
- Acronym
- Cesarean
- Status last verified
- Nov 2021
- First submitted
- 2 Nov 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclavian / Infraclavicular Axillary Vein Collapsibility Index in Pregnant Patients
- ClinicalTrials.gov ID
- NCT05120258
- Acronym / sponsor ID
- Cesarean / SCV
- Conditions
- Post Spinal Hypotension
- Keywords
- post spinal hypotension, the subclavian vein or infraclavicular axillary vein collapsibility index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 8 Nov 2021 (estimated)
- Primary completion
- 24 Jan 2022 (estimated)
- Study completion
- 2 Mar 2022 (estimated)
- First posted
- 15 Nov 2021 (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.
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4).
One of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7).
In this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ASA I-II physical status patients scheduled for cesarean section under spinal anesthesia
Key inclusion criteria (3 listed)
- Spinal anesthesia
- ceserean operation
- American Society of Anesthesiologists' (ASA) physical status I-II
Key exclusion criteria (3 listed)
- Patients who underwent cesarean section in emergency conditions
- Patients who underwent cesarean section under general anesthesia
- American Society of Anesthesiologists' (ASA) physical status III-IV
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
Predictive value of Subclavian / Infraclavicular Axillary Vein Collapsibility Index for detecting Postspinal hypotension
Time frame: 45 min
Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. This incidence is higher in pregnant women with a rate of 70%. Measurement of the IVC diameter and its collapsibility index before spinal anaesthesia has been shown to be a good predictive value of the occurrence of PSH. A previous study showed an acceptable correlation between the collapsibility of SCV (SCV-CI) and collapsibility of IVC (IVC-CI) in surgical and intensive care patients. In this study, we measured the preoperative collapsibility index of the SCV or the infraclavicular axillary vein during respiratory variation, and then examined whether these parameters could predict hypotension after spinal anaesthesia in patients undergoing ceserean
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
Related trials for Post Spinal Hypotension
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
Incidence of Post-spinal Hypotension
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Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
RecruitingObservational study
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
Hypotension, Spinal Anesthesia
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.
Emine ASLANLAR, assis. prof. principal investigator
selcuk univercity medical faculty
Questions about this trial
What is this clinical trial studying?
An observational study of Post Spinal Hypotension, run by Selcuk University.
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 3 inclusion and 3 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 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Emine ASLANLAR, assis. prof. (05556219830, draslanlar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of Subclavian / Infraclavicular Axillary Vein Collapsibility Index for detecting Postspinal hypotension (time frame: 45 min). 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 15 Nov 2021.