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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).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

Other trials in Turkey (Türkiye)

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 groups in NCT05874687
Study groupRoleWhat 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.

  1. 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.

  1. First posted25 May 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion1 Sep 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

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)
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

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.

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