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

NCT06048497 | Completed

• 1 other identifier: FTCCS
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Anesthesia; Cesarean Section

Keywords

Cesarean section; Carotid flow time; Preload fluid; Hypotension; Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  During surgery

Study Arms (2)

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

Non-preload

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

Interventions

Corrected carotid flow time measurement guided fluid preload DEVICE

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.

Preload

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (2)

Cukurova University

Adana, Saricam, 01330, Turkey (Türkiye)

Location

Çukurova University; Faculty of Medicine

Adana, Sarıçam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Demet Laflı Tunay, Dr.

  Çukurova University, Balcalı Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: November 15, 2022
• Primary Completion: May 20, 2023
• Study Completion: July 5, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)