Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management

Lipodystrophy Clinical Trial

Official title:

Respiratory Variation of Carotid Doppler Peak Velocity in Liposuction Fluid Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930106
• Other study ID #: R-2023-02
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: TJ Plast Advanced Center for Plastic Surgery
• Contact: Sergio Soto Hopkins, M.D.
• Phone: +526621191347
• Email: sergio_sotohopkins[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to compare the hemodynamic parameters, postoperative plethysmography variability index, the total amount of postoperative intravenous fluid administration needed, and the urine output of two methods of fluid resuscitation during liposuction surgery. One method involves using carotid artery Doppler peak velocity variation, while the other is the conventional fluid ratio.

Description:

The research will involve 50 female participants who have undergone liposuction and will be divided into two groups.

Group 1: Fluid administration will be determined by the intraoperative fluid ratio. This ratio is calculated by dividing the sum of subcutaneous infiltration and intravenous fluid by the total aspirate volume. Depending on the aspiration volume, it will be maintained at 1-1.4.

Group 2: Participants will be given a fluid maintenance rate of 1.5 ml/kg/h. To determine fluid responsiveness, the carotid artery peak velocity variation (ΔVPeak-CA) will be measured before, during, and after the procedure. If the ΔVPeak-CA goes above 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes, and the team will re-measure fluid responsiveness 10 minutes after each ΔVPeaK-CA.

During the examination, a single cardiothoracic anesthesiologist will use a 13-6 MHz linear probe (Fujifilm Sonosite M-Turbo) to measure the peak velocity of the carotid artery on the left side. The sample volume will be positioned at the center of the lumen, 2 cm from the bulb, and a pulsed wave Doppler examination will be conducted.

To measure the ΔVPeak-CA, the investigators will calculate the maximum and minimum values during one respiratory cycle. This will be done by using the formula: 100x (maximum peak velocity - minimum peak velocity) / [(maximum peak velocity + minimum peak velocity)/2].

Surgical technique

The superwet tumescence technique will be the only method utilized for infiltration during the procedure. All participants will undergo power-assisted liposuction, and a single surgeon will operate. The wetting solution will contain 1000cc of normal saline and 2mg of epinephrine in a 1:500,000 ratio. The total Infiltration volume will depend on the patient.

The total amount of aspiration will depend on the patient and surgery plan and can vary between 2500 to 5000 ml

During the surgical procedure, the investigators will monitor vital signs such as blood pressure, heart rate, temperature, oxygen levels, and urine output. Additionally, the investigators will track the amount of fluids given and removed, and the volume of blood aspirated.

Following surgery, participants will be hospitalized for 24 hours. During this time, the investigators will closely monitor the plethysmography variability index (PVI) in both groups. If the PVI exceeds 15%, participants will receive a ringer lactate fluid bolus of 4-6 ml/kg. Additionally, the investigators will keep track of their urine output, total fluid intake, and vital signs

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female patients between 21 and 60 years old

• Liposuction with or without abdominoplasty

• American Society of Anesthesiologists ? & ??.

Exclusion Criteria:

• History of previous liposuction surgery

• American Society of Anesthesiologist III

• Coagulation disorders

• Cardiopulmonary disorders

Related Conditions & MeSH terms

• Lipodystrophy

Intervention

Other:
• Intraoperative fluid ratio
This ratio is calculated by dividing the sum of procedure subcutaneous infiltration and intravenous fluid by the total aspirate volume during surgery

Device:
• Carotid Artery Doppler Peak Velocity Variation
Patients will be given a fluid maintenance rate of 1.5 ml/kg/h. To determine fluid responsiveness, the carotid artery peak velocity variation (?VPeak-CA) will be measured before, during, and after the procedure. If the ?VPeak-CA goes above 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes, and the team will re-measure fluid responsiveness 10 minutes after each ?VPeaK-CA.

Locations

Country	Name	City	State
Mexico	TJ Plast out patient, S.A. de C.V.	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
TJ Plast Advanced Center for Plastic Surgery

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort s — View Citation

Song Y, Kwak YL, Song JW, Kim YJ, Shim JK. Respirophasic carotid artery peak velocity variation as a predictor of fluid responsiveness in mechanically ventilated patients with coronary artery disease. Br J Anaesth. 2014 Jul;113(1):61-6. doi: 10.1093/bja/a — View Citation

Wang G, Cao WG, Zhao TL. Fluid management in extensive liposuction: A retrospective review of 83 consecutive patients. Medicine (Baltimore). 2018 Oct;97(41):e12655. doi: 10.1097/MD.0000000000012655. Erratum In: Medicine (Baltimore). 2018 Nov;97(44):e13212. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Postoperative PVi	Following surgery, patients will be hospitalized for 24 hours. Throughout this period, the investigators will keep a close eye on the Plethysmography Variability Index (PVi) in both groups. The PVi is a dynamic index that measures the relative variability of the plethysmography waveform detected noninvasively from a pulse oximetry sensor, ranging from 0 to 100. By automatically calculating the dynamic changes that occur during the respiratory cycle, it uses the detected amplitudes. A higher variability in the plethysmography waveform has been linked to preload dependence and fluid responders. If the PVi exceeds 15%, the patient will receive a fluid bolus of lactated ringer solution at a rate of 4-6 ml/kg over 10-15 minutes.	24 hours
Primary	Postoperative intravenous fluid balance	Following surgery, patients will be hospitalized for 24 hours. During the postoperative period, the investigators will keep track and document the exact volume of fluid administered in milliliters.	24 hours
Secondary	The intraoperative total volume of urine in the patient's catheter bag	During the intraoperative period, the investigators will measure and record the total volume of urine accumulated in the patient's catheter bag over the surgery period and will report urine output measured in milliliters per kilogram per hour.	the duration of the surgery
Secondary	The postoperative total volume of urine in the patient's catheter bag	During the postoperative period, the investigators will measure and record the total volume of urine accumulated in the patient's catheter bag over a 24-hour period and will report urine output measured in milliliters per kilogram per hour.	24 hours
Secondary	Mean arterial blood pressure during hospitalization	Following surgery, patients will be hospitalized for 24 hours. During this time, the investigators will monitor Mean arterial pressure	24 hours
Secondary	The intraoperative intravenous fluid balance	Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters.	the duration of the surgery