Spinal AnesthesiaNCT06048497
The Role of Carotid Flow Time-Based Fluid Administration in Caesarean Section
An observational study of Spinal Anesthesia and Cesarean Section, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial summary
It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Spinal Anesthesia, Cesarean Section
- What is being tested?
- Corrected carotid flow time measurement guided fluid preload
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 5 Jul 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: ASA II pregnant women between the ages of 20 and 40 who were undergoing elective cesarean section, and had uncomplicated singleton term pregnancies, and agreed to participate in the study were included.
Who may be able to join
- 20-40 years of age pregnant women
- American Society of Anesthesiologists (ASA) physical status-II patients
- Uncomplicated, singleton, term pregnancy
- Elective C/S surgery
Who cannot join
- Placental disorders
- Gestational hypertensive disorders
- Morbid obesity (BMI>39 kg/m2)
- Carotid stenosis more than 50%
- Baseline SAP more than 160 mmHg
- Arrhythmia
- History of cardiovascular or cerebrovascular disease, and chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m2)
- Emergency surgery
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cukurova University
Adana, Saricam, 01330
Çukurova University; Faculty of Medicine
Adana, Sarıçam, 01330
About this study
Official title: The Role of Carotid Flow Time-Based Fluid Administration in the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Caesarean Section
It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery. Pregnant women who underwent cesarean section under spinal anesthesia were included in this prospective study. In the preoperative care unit, patients were assigned to two groups according to their baseline FTc values. Patients with baseline FTc < 327 ms were assigned to the first group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. On the other hand, patients with baseline FTc > 327 ms were assigned to the second group, and preload fluid was not administered to these patients. Intraoperative hemodynamic data were recorded for each patient.
- Conditions
- Spinal Anesthesia, Cesarean Section
- Being tested
- Corrected carotid flow time measurement guided fluid preload
- Keywords
- Cesarean section, Carotid flow time, Preload fluid, Hypotension, 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.
Corrected carotid flow time measurement guided fluid preloadDevice
Preoperative FTcs of pregnant women who underwent C/S operation were measured, and those below the cut-off value (327 ms) determined in previous studies were preloaded with Ringer Lactate until FTc was > 327 ms.
| Study group | Role | What they receive |
|---|---|---|
| Preload | Patients with baseline FTc < 327 ms were assigned to the preload group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. Receives: Device: Corrected carotid flow time measurement guided fluid preload | |
| Non-preload | Patients with baseline FTc > 327 ms were assigned to the non-preload group, and preload fluid was not administered to these patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of intra-operative hypotension
Hypotension definitions included systolic arterial pressure (SAP) below 80 mmHg, or mean arterial pressure (MAP) below 65 mmHg, or a decrease in SAP of more than 30% below baseline, or a decrease in MAP of more than 20% below baseline, or any combination of all these definitions.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Nov 2022
- Primary completion20 May 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cukurova 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-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Laflı Tunay, Cukurova University
- Investigators
- Demet Laflı Tunay, Dr., Principal investigator, Çukurova University, Balcalı Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048497
- Sponsor's protocol ID
- FTCCS
- Status last verified
- Sep 2023
- First submitted
- 15 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data were anonymized by the local researcher. Therefore, data collection was pseudonymous and the patient's name did not appear on any case report form or other study document. All collected data were kept confidential. This study was conducted in accordance with the revision of the Declaration of Helsinki (2008). International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) was strictly adhered to.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Carotid Flow Time-Based Fluid Administration in the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT06048497
- Acronym / sponsor ID
- FTCCS
- Conditions
- Spinal Anesthesia, Cesarean Section
- Keywords
- Cesarean section, Carotid flow time, Preload fluid, Hypotension, Spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 21 Sep 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.
It has been reported that corrected carotid flow time (FTc) may indicate the responsiveness of spontaneously breathing patients to fluid therapy. The primary objective of the study is to determine the effect of fluid preload applied to patients with preanesthetic FTc values below the cut-off value on the incidence of hypotension in cesarean section (C/S) surgery. Pregnant women who underwent cesarean section under spinal anesthesia were included in this prospective study. In the preoperative care unit, patients were assigned to two groups according to their baseline FTc values. Patients with baseline FTc < 327 ms were assigned to the first group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. On the other hand, patients with baseline FTc > 327 ms were assigned to the second group, and preload fluid was not administered to these patients. Intraoperative hemodynamic data were recorded for each patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preload | – | Device: Corrected carotid flow time measurement guided fluid preloadPatients with baseline FTc < 327 ms were assigned to the preload group, and Ringer Lactate (RL) preload fluid administration to these patients was continued until FTc > 327 ms. |
| Non-preload | – | –Patients with baseline FTc > 327 ms were assigned to the non-preload group, and preload fluid was not administered to these patients |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- ASA II pregnant women between the ages of 20 and 40 who were undergoing elective cesarean section, and had uncomplicated singleton term pregnancies, and agreed to participate in the study were included.
Key inclusion criteria (4 listed)
- 20-40 years of age pregnant women
- American Society of Anesthesiologists (ASA) physical status-II patients
- Uncomplicated, singleton, term pregnancy
- Elective C/S surgery
Key exclusion criteria (8 listed)
- Placental disorders
- Gestational hypertensive disorders
- Morbid obesity (BMI>39 kg/m2)
- Carotid stenosis more than 50%
- Baseline SAP more than 160 mmHg
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 |
|---|---|---|
| Corrected carotid flow time measurement guided fluid preloadPreoperative FTcs of pregnant women who underwent C/S operation were measured, and those below the cut-off value (327 ms) determined in previous studies were preloaded with Ringer Lactate until FTc was > 327 ms. | Device | Preload |
Primary outcome
The incidence of intra-operative hypotension
Time frame: During surgery
Hypotension definitions included systolic arterial pressure (SAP) below 80 mmHg, or mean arterial pressure (MAP) below 65 mmHg, or a decrease in SAP of more than 30% below baseline, or a decrease in MAP of more than 20% below baseline, or any combination of all these definitions.
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 28 Sep 2023.
- Individual participant dataSharing planned: No. All data were anonymized by the local researcher. Therefore, data collection was pseudonymous and the patient's name did not appear on any case report form or other study document. All collected data were kept confidential. This study was conducted in accordance with the revision of the Declaration of Helsinki (2008). International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) was strictly adhered to.
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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.
Demet Laflı Tunay, Dr. principal investigator
Çukurova University, Balcalı Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia and Cesarean Section, run by Cukurova University at 2 sites 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 8 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 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
The incidence of intra-operative hypotension (time frame: During surgery). 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 28 Sep 2023.