- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05930106
Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management
Respiratory Variation of Carotid Doppler Peak Velocity in Liposuction Fluid Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Baja California
-
Tijuana, Baja California, Mexico, 9288
- TJ Plast out patient, S.A. de C.V.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients between 21 and 60 years old
- Liposuction with or without abdominoplasty
- American Society of Anesthesiologists Ӏ & ӀӀ.
Exclusion Criteria:
- History of previous liposuction surgery
- American Society of Anesthesiologist III
- Coagulation disorders
- Cardiopulmonary disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Intraoperative fluid ratio
The intraoperative fluid ratio will determine fluid administration.
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.
|
This ratio is calculated by dividing the sum of procedure subcutaneous infiltration and intravenous fluid by the total aspirate volume during surgery
|
|
Experimental: Group Carotid Artery 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 (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.
|
Patients 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Postoperative PVi
Time Frame: 24 hours
|
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
|
|
Postoperative intravenous fluid balance
Time Frame: 24 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The intraoperative total volume of urine in the patient's catheter bag
Time Frame: the duration of the surgery
|
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
|
|
The postoperative total volume of urine in the patient's catheter bag
Time Frame: 24 hours
|
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
|
|
Mean arterial blood pressure during hospitalization
Time Frame: 24 hours
|
Following surgery, patients will be hospitalized for 24 hours.
During this time, the investigators will monitor Mean arterial pressure
|
24 hours
|
|
The intraoperative intravenous fluid balance
Time Frame: the duration of the surgery
|
Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters.
|
the duration of the surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sergio Soto Hopkins, M.D., TJ Plast Advanced Center for Plastic Surgery
- Study Chair: Hector Milla, M.D., TJ Plast Advanced Center for Plastic Surgery
- Study Director: Israel Espino Gaucin, M.D., TJ Plast Advanced Center for Plastic Surgery
Publications and helpful links
General Publications
- 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/aeu057. Epub 2014 Apr 9.
- 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 study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26.
- 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. doi: 10.1097/MD.0000000000013212.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-2023-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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