HypotensionCESERAN TAPSENCT05874687
Tricuspid Annular Plane Systolic Excursion to Predict Arterial Hypotension Caused by Spinal Anesthesia in Caesarean Section
An observational study of Hypotension, run by Aydin Maternity and Child Health Hospital at 1 site in Turkey (Türkiye).
Trial summary
This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- hypotension + treat
- Type of treatment
- Injection or infusion
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Oct 2023
- 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 20 to 35 years
- Women only
- Adult
Study population: The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study
Who may be able to join
- ASA 2
- 37-42 gestational-week single pregnancies
- Being between the ages of 20-35
- BMI between 20-35
Who cannot join
- Non-sinus rhythm
- ASA III and above
- Known heart disease
- Multiple pregnancy
- Expected massive intraoperative loss (i.e., placenta accreta or placenta previa)
- Severe pulmonary hypertension, wall motion disorder, severe valve disease, hypertrophic or dilated cardiomyopathy in echocardiography
- A TAPSE value of 1.7 cm or less
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Maternity and Child Health Hospital
Aydin
About this study
This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study.
Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.
Read the detailed description
This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study.
Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.
Echocardiography The same observer will perform TTE on all patients in the left lateral decubitus position with an echocardiography device. The values of all parameters will be determined by taking the average values of three cardiac cycle measurements. Measurement methods will be used in accordance with the guidelines of the American Society of Echocardiography. M-Mode, 2D (2D) images, color, pulse and continuous wave Doppler and tissue Doppler measurements will be taken from all subjects who are suitable for standard Echocardiography. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long axis view.
FAC and TAPSE will be used to evaluate Right Ventricular (RV) systolic functions. Tricuspid E and A Wave Velocity and E/A Ratio will be measured to evaluate the diastolic function of the RV. TAPSE, echocardiography device and TTE will be used for all patients by the same observer. Echocardiography will be performed in the left lateral supine position. TAPSE will be calculated in an apical 4-chamber view by placing an M-mode cursor across the Tricuspid Ring and measuring the amount of longitudinal movement at peak systole and the values will be recorded by averaging the five cardiac cycle measurements.
Patients will be visualized in the supine position through the subxiphoid window of the Inferior Vena Cava (IVC). The cursor will be placed 1 cm distal to the hepatic vein IVC entry point and the IVC diameter will be monitored for 30 seconds in M-Mode. And the measurement will be made from the region where the diameter of the inferior vena cava is in inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. The Inferior Vena Cava Collapse Index (IVC-CI) will be calculated by using the formula IVC-CI = (IVCexp - IVCins) / IVCexp.
Spinal Anesthesia Following the echocardiographic measurements, spinal anesthesia will be administered with 2.1 mL of hyperbaric Bupivacaine 5% to the L 4-5 or L 3-4 intervertebral spaces with a 25-gauge spinal needle in the sitting position. All patients will then be simultaneously loaded with a Ringer's Lactate solution (10 mL/kg over 15 minutes). Surgery will be started when the sensory block reaches the T6 level.
Heart Rate and Mean Arterial Pressure (MAP) will be recorded throughout the procedure (every 2 minutes for the first 15 minutes). Ephedrine (in 6 mg increments) will be used as well as the isotonic balanced crystalloid solution to treat hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg (250 mL bolus). The Ephedrine dose will be recorded. Bradycardia, which is defined as a heart rate less than 50 beats per minute, will be treated with intravenous Atropine (0.5 mg).
The present study aimed to determine the predictive values of IVCCI and IJVCI in determining PSAH. The secondary purpose was to compare these two predictive values.
- Conditions
- Hypotension
- Being tested
- hypotension + treat
- Keywords
- Tricuspid Annuler Plane Systolic Excursion, Hypotension-, Ceserean section, Spinal anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotension + treatDrug
Heart Rate and Mean Arterial Pressure (MAP) will be recorded throughout the procedure (every 2 minutes for the first 15 minutes). Ephedrine (in 6 mg increments) will be used as well as the isotonic balanced crystalloid solution to treat hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg (250 mL bolus). The Ephedrine dose will be recorded. Bradycardia, which is defined as a heart rate less than 50 beats per minute, will be treated with intravenous Atropine (0.5 mg).
| Study group | Role | What they receive |
|---|---|---|
| 1: hypotension +, | hypotension +: hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg Receives: Drug: hypotension + treat | |
| 2:hypotension - | hypotension -:none hypotension (hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ceserenan tapse
The primary outcome measure was the development of hypotension after spinal anesthesia.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
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
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aydin Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874687
- Sponsor's protocol ID
- 2023
- Acronym
- CESERAN TAPSE
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 25 May 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 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tricuspid Annular Plane Systolic Excursion to Predict Arterial Hypotension Caused by Spinal Anesthesia in Caesarean Section
- ClinicalTrials.gov ID
- NCT05874687
- Acronym / sponsor ID
- CESERAN TAPSE / 2023
- Conditions
- Hypotension
- Keywords
- Tricuspid Annuler Plane Systolic Excursion, Hypotension-, Ceserean section, Spinal anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Aydin Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 25 May 2023 (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 cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study.
Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.
Detailed description
This cross-sectional blinded study was planned to be conducted in Aydın Gynecology and Pediatrics Hospital between June 2023 and September 2023. The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study.
Patients with emergencies and uncontrolled systemic comorbidities (e.g., cardiovascular, respiratory or renal) and patients with expected massive intraoperative loss (i.e., placenta accreta or placenta previa) are planned to be excluded from the study. Also, cases receiving intravenous fluid preload will be excluded.
Echocardiography The same observer will perform TTE on all patients in the left lateral decubitus position with an echocardiography device. The values of all parameters will be determined by taking the average values of three cardiac cycle measurements. Measurement methods will be used in accordance with the guidelines of the American Society of Echocardiography. M-Mode, 2D (2D) images, color, pulse and continuous wave Doppler and tissue Doppler measurements will be taken from all subjects who are suitable for standard Echocardiography. LV Ejection Fraction (EF) measurements will be evaluated in the parasternal long axis view.
FAC and TAPSE will be used to evaluate Right Ventricular (RV) systolic functions. Tricuspid E and A Wave Velocity and E/A Ratio will be measured to evaluate the diastolic function of the RV. TAPSE, echocardiography device and TTE will be used for all patients by the same observer. Echocardiography will be performed in the left lateral supine position. TAPSE will be calculated in an apical 4-chamber view by placing an M-mode cursor across the Tricuspid Ring and measuring the amount of longitudinal movement at peak systole and the values will be recorded by averaging the five cardiac cycle measurements.
Patients will be visualized in the supine position through the subxiphoid window of the Inferior Vena Cava (IVC). The cursor will be placed 1 cm distal to the hepatic vein IVC entry point and the IVC diameter will be monitored for 30 seconds in M-Mode. And the measurement will be made from the region where the diameter of the inferior vena cava is in inspiration (IVCins) and expiration (IVCexp) while the patient is breathing normally. The Inferior Vena Cava Collapse Index (IVC-CI) will be calculated by using the formula IVC-CI = (IVCexp - IVCins) / IVCexp.
Spinal Anesthesia Following the echocardiographic measurements, spinal anesthesia will be administered with 2.1 mL of hyperbaric Bupivacaine 5% to the L 4-5 or L 3-4 intervertebral spaces with a 25-gauge spinal needle in the sitting position. All patients will then be simultaneously loaded with a Ringer's Lactate solution (10 mL/kg over 15 minutes). Surgery will be started when the sensory block reaches the T6 level.
Heart Rate and Mean Arterial Pressure (MAP) will be recorded throughout the procedure (every 2 minutes for the first 15 minutes). Ephedrine (in 6 mg increments) will be used as well as the isotonic balanced crystalloid solution to treat hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg (250 mL bolus). The Ephedrine dose will be recorded. Bradycardia, which is defined as a heart rate less than 50 beats per minute, will be treated with intravenous Atropine (0.5 mg).
The present study aimed to determine the predictive values of IVCCI and IJVCI in determining PSAH. The secondary purpose was to compare these two predictive values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: hypotension +, | – | Drug: hypotension + treathypotension +: hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg |
| 2:hypotension - | – | –hypotension -:none hypotension (hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study was designed for adult pregnant female cases between the ages of 20 and 35. Patients with Class II American Society of Anesthesiologists (ASA) physical status, scheduled for elective cesarean section under subarachnoid block and who gave informed consent were planned to be included in the study
Key inclusion criteria (4 listed)
- ASA 2
- 37-42 gestational-week single pregnancies
- Being between the ages of 20-35
- BMI between 20-35
Key exclusion criteria (7 listed)
- Non-sinus rhythm
- ASA III and above
- Known heart disease
- Multiple pregnancy
- Expected massive intraoperative loss (i.e., placenta accreta or placenta previa)
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 |
|---|---|---|
| hypotension + treatHeart Rate and Mean Arterial Pressure (MAP) will be recorded throughout the procedure (every 2 minutes for the first 15 minutes). Ephedrine (in 6 mg increments) will be used as well as the isotonic balanced crystalloid solution to treat hypotension defined as a decreased SAB greater than 20% of baseline, a decreased MAP below 90 mmHg, or a MAP of 65 mmHg (250 mL bolus). The Ephedrine dose will be recorded. Bradycardia, which is defined as a heart rate less than 50 beats per minute, will be treated with intravenous Atropine (0.5 mg). | Drug | 1: hypotension +, |
Primary outcome
ceserenan tapse
Time frame: 3 months
The primary outcome measure was the development of hypotension after spinal anesthesia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Undecided
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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, run by Aydin Maternity and Child Health Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 25 May 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 Turkey (Türkiye). 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?
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?
ceserenan tapse (time frame: 3 months). 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 25 May 2023.