Supine Hypotensive SyndromeNCT04934995
Arm and Ankle Blood Pressure Cuffs During C-Section
An observational study of Supine Hypotensive Syndrome and Cesarean Section Complications, run by Ohio State University at 1 site in United States.
Trial summary
This is a single center prospective self-control study to validate the effectiveness of left uterine displacement after subarachnoid block (SAB) with simultaneous measurements of blood pressure (BP) on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD) at The Ohio State University… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Supine Hypotensive Syndrome, Cesarean Section Complications, Anesthesia Complication
- What is being tested?
- Blood Pressure Cuff
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2021to 20 Oct 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center
Who may be able to join
- Age ≥ 18 years old
- Women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia
- American Society of Anesthesiologists Physical Status I-III
- Body mass index during pregnancy ≥ 35 kg/m2
- Able to consent in English language
- Singleton pregnancy
Who cannot join
- Women undergoing elective cesarean delivery at The Ohio State University Wexner Medical Center under anesthesia other than spinal anesthesia (i.e. general and/or epidural anesthesia)
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Arm and Ankle Blood Pressure During Cesarean Delivery: A Blood Pressure Cuffs Pilot Study
This is a single center prospective self-control study to validate the effectiveness of left uterine displacement after subarachnoid block (SAB) with simultaneous measurements of blood pressure (BP) on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center
Read the detailed description
In the last three decades, numerous interventions have been studied and implemented into our daily practice, such as pre-loading versus co-loading, phenylephrine versus ephedrine, and phenylephrine infusion versus intermittent boluses. In addition, the effectiveness of left uterine displacement (LUD) to improve blood flow and pressure remains unclear. Also, there are issues to be addressed on this regard, including:
- Poor placental perfusion from inadequate LUD due to the potential impact of supine hypotensive syndrome (SHS) secondary to aortocaval compression especially after SAB;
- Shivering during cesarean delivery (CD) resulting in inaccurate BP measurements, the incidence of shivering during CD is reported to be 21.9%. It is unclear the impact of shivering during CD on blood pressure (BP) measurements;
- Patient discomfort during BP measurements, calf > arm > ankle
The Investigators are conducting a single center prospective self-control study aiming to validate the effectiveness of LUD after SAB with simultaneous measurements of BP on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD). In addition, the Investigators will determine whether ankle BP correlates more accurately than arm SBP with the incidence of nausea/vomiting and category II or III fetal heart tracing and bradycardia after SAB and LUD under no shivering conditions and the impact of body mass index and antepartum estimation of newborn weight on SHS after the SAB.
- Being tested
- Blood Pressure Cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure CuffOther
After obtaining consent and confirming eligibility, Blood Pressure cuffs will be used as specified below:
Cuff size: large BP cuffs will be the default size for both arm and ankle measurements, but can be changed as clinically indicated based on circumferences of limbs Cuff location: BP cuffs will be placed on the contralateral arm to the main peripheral IV following standard procedures. Left ankle cuff will be placed underneath intermittent pneumatic compression cuffs Ankle blood pressure monitor screen will be covered. Thus, anesthesia providers will not be able to make any clinical decisions based on ankle blood pressures but arm blood pressure (standard) instead.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Adult women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia, ASA physical status I-III with a BMI during pregnancy ≥ 35 kg/m2 and singleton pregnancy. Receives: Other: Blood Pressure Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of SBP measured between arm and ankle during elective CD before SAB
Arm Systolic Blood Pressure values will be compared with the ankle SBP values before subarachnoid anesthesia. Baseline SBP will be measured pre-spinal anesthesia in supine position (after standard of care left uterine displacement maneuver is performed).
Measured: Immediately before subarachnoid anesthesia block (after standard of care left uterine displacement maneuver is performed).
Difference of SBP measured between arm and ankle during elective CD after SAB (before incision)
Arm Systolic Blood Pressure values will be compared with the ankle SBP values after subarachnoid anesthesia. Postspinal SBP will be measured in supine position, after LUD is performed
Measured: Immediately after subarachnoid anesthesia block is completed
Secondary outcomes (2)
Incidence of intraoperative nausea in our patient population
the incidence of intraoperative nausea will be assessed during anesthesia and surgery
Measured: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
Incidence of intraoperative vomiting in our patient population
the incidence of intraoperative vomiting will be assessed during anesthesia and surgery
Measured: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start14 Mar 2021
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supine Hypotensive SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Qun Hu, Ohio State University
- Investigators
- Ling-Qun Hu, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934995
- Sponsor's protocol ID
- 2020H0502
- Status last verified
- Nov 2024
- First submitted
- 29 Mar 2021
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
PubMed 20455872Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
PubMed 12032019Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
PubMed 17667564Chungsamarnyart Y, Wacharasint P, Carvalho B. Hemodynamic profiles with and without left uterine displacement: A randomized study in term pregnancies receiving subarachnoid blockade for cesarean delivery. J Clin Anesth. 2020 Sep;64:109796. doi: 10.1016/j.jclinane.2020.109796. Epub 2020 Apr 16.
PubMed 32305794
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Arm and Ankle Blood Pressure During Cesarean Delivery: A Blood Pressure Cuffs Pilot Study
- ClinicalTrials.gov ID
- NCT04934995
- Acronym / sponsor ID
- 2020H0502
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 22 Jun 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.
This is a single center prospective self-control study to validate the effectiveness of left uterine displacement after subarachnoid block (SAB) with simultaneous measurements of blood pressure (BP) on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center
Detailed description
In the last three decades, numerous interventions have been studied and implemented into our daily practice, such as pre-loading versus co-loading, phenylephrine versus ephedrine, and phenylephrine infusion versus intermittent boluses. In addition, the effectiveness of left uterine displacement (LUD) to improve blood flow and pressure remains unclear. Also, there are issues to be addressed on this regard, including:
- Poor placental perfusion from inadequate LUD due to the potential impact of supine hypotensive syndrome (SHS) secondary to aortocaval compression especially after SAB;
- Shivering during cesarean delivery (CD) resulting in inaccurate BP measurements, the incidence of shivering during CD is reported to be 21.9%. It is unclear the impact of shivering during CD on blood pressure (BP) measurements;
- Patient discomfort during BP measurements, calf > arm > ankle
The Investigators are conducting a single center prospective self-control study aiming to validate the effectiveness of LUD after SAB with simultaneous measurements of BP on the arm and left ankle during surgery in patients undergoing cesarean delivery (CD). In addition, the Investigators will determine whether ankle BP correlates more accurately than arm SBP with the incidence of nausea/vomiting and category II or III fetal heart tracing and bradycardia after SAB and LUD under no shivering conditions and the impact of body mass index and antepartum estimation of newborn weight on SHS after the SAB.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Other: Blood Pressure CuffAdult women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia, ASA physical status I-III with a BMI during pregnancy ≥ 35 kg/m2 and singleton pregnancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing cesarean delivery (CD) at The Ohio State University Wexner Medical Center
Key inclusion criteria (6 listed)
- Age ≥ 18 years old
- Women undergoing cesarean delivery at The Ohio State University Wexner Medical Center under spinal anesthesia
- American Society of Anesthesiologists Physical Status I-III
- Body mass index during pregnancy ≥ 35 kg/m2
- Able to consent in English language
Key exclusion criteria (2 listed)
- Women undergoing elective cesarean delivery at The Ohio State University Wexner Medical Center under anesthesia other than spinal anesthesia (i.e. general and/or epidural anesthesia)
- Prisoners
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 |
|---|---|---|
| Blood Pressure CuffAfter obtaining consent and confirming eligibility, Blood Pressure cuffs will be used as specified below: Cuff size: large BP cuffs will be the default size for both arm and ankle measurements, but can be changed as clinically indicated based on circumferences of limbs Cuff location: BP cuffs will be placed on the contralateral arm to the main peripheral IV following standard procedures. Left ankle cuff will be placed underneath intermittent pneumatic compression cuffs Ankle blood pressure monitor screen will be covered. Thus, anesthesia providers will not be able to make any clinical decisions based on ankle blood pressures but arm blood pressure (standard) instead. | Other | Study Population |
Primary outcome
Difference of SBP measured between arm and ankle during elective CD before SAB
Time frame: Immediately before subarachnoid anesthesia block (after standard of care left uterine displacement maneuver is performed).
Arm Systolic Blood Pressure values will be compared with the ankle SBP values before subarachnoid anesthesia. Baseline SBP will be measured pre-spinal anesthesia in supine position (after standard of care left uterine displacement maneuver is performed).
Difference of SBP measured between arm and ankle during elective CD after SAB (before incision)
Time frame: Immediately after subarachnoid anesthesia block is completed
Arm Systolic Blood Pressure values will be compared with the ankle SBP values after subarachnoid anesthesia. Postspinal SBP will be measured in supine position, after LUD is performed
2 secondary outcomes
Incidence of intraoperative nausea in our patient population
Time frame: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
Incidence of intraoperative vomiting in our patient population
Time frame: Up to 3 hours from OR admission. Immediately before anesthesia (subarachnoid block) and until operating room discharge
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 21 Nov 2024.
- Background: PubMed 20455872Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
- Background: PubMed 12032019Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
- Background: PubMed 17667564Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
- Background: PubMed 32305794Chungsamarnyart Y, Wacharasint P, Carvalho B. Hemodynamic profiles with and without left uterine displacement: A randomized study in term pregnancies receiving subarachnoid blockade for cesarean delivery. J Clin Anesth. 2020 Sep;64:109796. doi: 10.1016/j.jclinane.2020.109796. Epub 2020 Apr 16.
- 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.
Ling-Qun Hu, MD principal investigator
Ohio State University
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 Supine Hypotensive Syndrome and Cesarean Section Complications, run by Ohio State University at 1 site in United States.
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 6 inclusion and 2 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 21 Nov 2024. 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 States. 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?
Difference of SBP measured between arm and ankle during elective CD before SAB (time frame: Immediately before subarachnoid anesthesia block (after standard of care left uterine displacement maneuver is performed).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934995, which also lists 4 linked publications.
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 21 Nov 2024.