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Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management

Primary Purpose

Lipodystrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraoperative fluid ratio
Carotid Artery Doppler Peak Velocity Variation
Sponsored by
TJ Plast Advanced Center for Plastic Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipodystrophy focused on measuring liposuction, carotid artery doppler peak velocity variation, plethysmography variability index, fluid ratio

Eligibility Criteria

21 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Group Intraoperative fluid ratio

    Group Carotid Artery Peak Velocity Variation

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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 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.
    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
    The intraoperative intravenous fluid balance
    Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters.

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    June 25, 2023
    Sponsor
    TJ Plast Advanced Center for Plastic Surgery
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05930106
    Brief Title
    Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management
    Official Title
    Respiratory Variation of Carotid Doppler Peak Velocity in Liposuction Fluid Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TJ Plast Advanced Center for Plastic Surgery

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lipodystrophy
    Keywords
    liposuction, carotid artery doppler peak velocity variation, plethysmography variability index, fluid ratio

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The research will involve 50 female patients who have undergone liposuction and will be divided into two groups. Group Intraoperative Fluid Ratio: 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 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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Intraoperative fluid ratio
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group Carotid Artery Peak Velocity Variation
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Intraoperative fluid ratio
    Intervention Description
    This ratio is calculated by dividing the sum of procedure subcutaneous infiltration and intravenous fluid by the total aspirate volume during surgery
    Intervention Type
    Device
    Intervention Name(s)
    Carotid Artery Doppler Peak Velocity Variation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mean Postoperative PVi
    Description
    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.
    Time Frame
    24 hours
    Title
    Postoperative intravenous fluid balance
    Description
    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.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    The intraoperative total volume of urine in the patient's catheter bag
    Description
    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.
    Time Frame
    the duration of the surgery
    Title
    The postoperative total volume of urine in the patient's catheter bag
    Description
    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.
    Time Frame
    24 hours
    Title
    Mean arterial blood pressure during hospitalization
    Description
    Following surgery, patients will be hospitalized for 24 hours. During this time, the investigators will monitor Mean arterial pressure
    Time Frame
    24 hours
    Title
    The intraoperative intravenous fluid balance
    Description
    Throughout the surgical procedure, the investigators will meticulously monitor and record the precise amount of fluid administered in milliliters.
    Time Frame
    the duration of the surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sergio Soto Hopkins, M.D.
    Phone
    526621191347
    Email
    sergio_sotohopkins@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sergio Soto Hopkins, M.D.
    Organizational Affiliation
    TJ Plast Advanced Center for Plastic Surgery
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Hector Milla, M.D.
    Organizational Affiliation
    TJ Plast Advanced Center for Plastic Surgery
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Israel Espino Gaucin, M.D.
    Organizational Affiliation
    TJ Plast Advanced Center for Plastic Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Data obtained through this study may be provided to qualified researchers interested in liposuction fluid management. Data will be coded, and approval consent forms it's a prerequisite.
    IPD Sharing Time Frame
    2 months after publication and for 24 months
    IPD Sharing Access Criteria
    Qualified researchers can request access to IPD, and will be provided following the review and approval of the research proposal
    Citations:
    PubMed Identifier
    30313055
    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.
    Results Reference
    background
    PubMed Identifier
    24722322
    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/aeu057. Epub 2014 Apr 9.
    Results Reference
    result
    PubMed Identifier
    26123610
    Citation
    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.
    Results Reference
    result

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    Carotid Doppler Peak Velocity Variation in Liposuction Fluid Management

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