The Role of Carotid Flow Time-Based Fluid Administration in Caesarean Section

Sponsor

Cukurova University (Other)

Overall Status

Completed

CT.gov ID

NCT06048497

Collaborator

(none)

Enrollment

Locations

7.6

Actual Duration (Months)

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia Related Hypotension Corrected Carotid Flow Time	Device: Corrected carotid flow time measurement guided fluid preload

Study Design

Study Type:

Observational

Actual Enrollment :

72 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Role of Carotid Flow Time-Based Fluid Administration in the Incidence of Hypotension After Spinal Anesthesia in Patients Undergoing Caesarean Section

Actual Study Start Date :

Nov 15, 2022

Actual Primary Completion Date :

May 20, 2023

Actual Study Completion Date :

Jul 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Corrected carotid flow time measurement guided fluid preload 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.
Non-preload Patients with baseline FTc > 327 ms were assigned to the non-preload group, and preload fluid was not administered to these patients

Arm

Intervention/Treatment

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.

Device: Corrected carotid flow time measurement guided fluid preload

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.

Non-preload

Patients with baseline FTc > 327 ms were assigned to the non-preload group, and preload fluid was not administered to these patients

Outcome Measures

Primary Outcome Measures

The incidence of intra-operative hypotension [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

20-40 years of age pregnant women
American Society of Anesthesiologists (ASA) physical status-II patients
Uncomplicated, singleton, term pregnancy
Elective C/S surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana	Saricam	Turkey	01330
2	Çukurova University; Faculty of Medicine	Adana	Sarıçam	Turkey	01330

Sponsors and Collaborators

Cukurova University

Investigators

Principal Investigator: Demet Laflı Tunay, Dr., Çukurova University, Balcalı Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Demet Laflı Tunay, Dr., Cukurova University

ClinicalTrials.gov Identifier:

NCT06048497

Other Study ID Numbers:

FTCCS

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Demet Laflı Tunay, Dr., Cukurova University

Cesarean section, corrected carotid flow time, preload fluid, hypotension, spinal anesthesia.

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Sep 21, 2023