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Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula

Primary Purpose

Lipodystrophy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Electrical Cardiometry (EC) ICON
Rohrich formula
Sponsored by
Ahmed Abdel Wahed Ali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipodystrophy focused on measuring Lipodystrophy

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male and female patients aged between 21 to 60 years.
  • American Society of Anesthesiologists (ASA) Ӏ& ӀӀ.
  • Large volume liposuction.

Exclusion Criteria:

  • Any bleeding& coagulation disorders.
  • Patients on regular anticoagulant or antiplatelet drugs.
  • History of previous surgery in treated areas.
  • Significant cardiopulmonary, hepatic or renal disease.

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

GROUP A

GROUP B

Arm Description

Fluid administration in the form of lactated ringer will be managed by Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2(10). Rohrich formula represents fluid maintinance,deficit and replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate).

Patients will receive fluid maintenance of lactated ringer 2 ml/kg/h, cardiometry guided SVV will be measured before and after induction then every 30 min ,it ranges between 5-15%, fluid bolus of lactated ringer 4 ml /kg over 15 min will be administered if SVV ˃ 15% .

Outcomes

Primary Outcome Measures

Mean arterial blood pressure
Mean arterial blood pressure at 4 litre aspiration of fat and at every litre aspirated after.

Secondary Outcome Measures

blood loss
estimation of blood loss by venous sample and suction sample
urine output
detection of tissue perfusion by urine output every hour

Full Information

First Posted
May 20, 2022
Last Updated
May 28, 2022
Sponsor
Ahmed Abdel Wahed Ali
Collaborators
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05402982
Brief Title
Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula
Official Title
Intraoperative Fluid Management of Large Volume Liposuction Surgery , Cardiometry Guided Stroke Volume Variation Versus Rohrich Formula
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Abdel Wahed Ali
Collaborators
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study is to compare the hemodynamic parameters of fluid resuscitation using Rohrich formula to cardiometry guided stroke volume variation in patients undergoing large volume liposuction surgery .
Detailed Description
The study will done on 50 patients divided equally into two groups. Group A Fluid administration in the form of lactated ringer will be managed by Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2. Rohrich formula represents fluid maintenance,deficit and replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate). Group B Patients will receive fluid maintenance of lactated ringer 2 ml/kg/h, cardiometry guided stroke volume variation will be measured before and after induction then every 30 min ,it ranges between 5-15%, fluid bolus of lactated ringer 4 ml /kg over 15 min will be administered if stroke volume variation ˃ 15% . Electrical cardiometry will be connected to the patient before induction,the skin will be clean and dry before placing the electrodes. Four electrodes will be applied, first one is at the upper part of the anterior aspect of the neck, second one is 5 cm below the first electrode at lower part of the neck, third one at the lower left thorax in line with xiphoid process at the level of anterior axillary line and the fourth one is 5 cm below the third electrode at the level of anterior axillary line.Electrical cardiometry will be connected to the sensor cable and the patient data will be applied as (gender - age - height - weight - blood pressure -heart rate - hemoglobin and oxygen saturation). Surgical Technique The wetting solution will be lactated ringer with epinephrine 1mg on 1 litre so concentration is 1:1,000,000.10 ml lidocaine 2% will be added.Subcutaneous infiltration of the wetting solution will facillate dissection and removal of fat ,the technique that will be used is traditional liposuction , suction assisted liposuction with super wet technique ( the amount of infiltration solution is equal to the amount of fat aspirate). The liposuction cannula is a multihole blunt tip cannula with a diameter of 3 to 6 mm, 4-6 mm for deep liposuction,2-4 mm for superficial liposuction and a length ranging between 10 to 30 cm. The surgeon will inject the wetting solution to the target area until it becomes tense then infiltrates the other side waiting 10 to 15 min after infiltration to begin suction .The aspirate will be collected in suction container, fat will separate from solution after approximately 1-2 h by gravity into upper yellowish part includes fat called supernatant and lower part includes blood tinged fluid called infranatant. Measurements Noninvasive blood pressure ,oxygen saturation, Heart rate before induction, 5 min and 15 min after induction then every 30 min. Urine output, baseline and every hour. Venous blood sample for measurement of hemoglobin and hematocrit level after aspiration of 4 litre of fat and for every litre after. Measurement of blood volume in aspirate by taking a sample from infranatant part after its separation from fat for hemoglobin level calculation and by equation of multiplying this hemoglobin concentration to infranatant volume divided by preoperative hemoglobin concentration, the investigators can measure blood volume in aspirate . Amount of intravenous and infiltration fluids. Amount of fat and total aspirate. Stroke volume variation before and after induction then every 30 min.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy
Keywords
Lipodystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will done on 50 patients divided equally into two groups. Group A Fluid administration in the form of lactated ringer will be managed by Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2(10). Rohrich formula represents fluid maintinance,deficit and replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate). Group B Patients will receive fluid maintenance of lactated ringer 2 ml/kg/h, cardiometry guided SVV will be measured before and after induction then every 30 min ,it ranges between 5-15%, fluid bolus of lactated ringer 4 ml /kg over 15 min will be administered if SVV ˃ 15% .
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP A
Arm Type
Other
Arm Description
Fluid administration in the form of lactated ringer will be managed by Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2(10). Rohrich formula represents fluid maintinance,deficit and replacement fluid ( 0.25 ml crystalloid given for each 1 ml above 4 litre of lipoaspirate).
Arm Title
GROUP B
Arm Type
Other
Arm Description
Patients will receive fluid maintenance of lactated ringer 2 ml/kg/h, cardiometry guided SVV will be measured before and after induction then every 30 min ,it ranges between 5-15%, fluid bolus of lactated ringer 4 ml /kg over 15 min will be administered if SVV ˃ 15% .
Intervention Type
Device
Intervention Name(s)
Electrical Cardiometry (EC) ICON
Intervention Description
Electrical Cardiometry (EC) ICON (Osypka Medical, Berlin, Germany) is an FDA approved device used for non-invasive measurement of some hemodynamic parameters as cardiac output,cardiac index, stroke volume,stroke volume variation, systemic vascular resistance, thoracic fluid content, ICON (index of contractility), variation of ICON,corrected flow time and systolic time ratio.The set data of EC are the height, weight,hemoglobin, Oxygen saturation(SPO2),age, gender ,blood pressure and heart rate(HR) of the patient
Intervention Type
Other
Intervention Name(s)
Rohrich formula
Intervention Description
Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2
Primary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure at 4 litre aspiration of fat and at every litre aspirated after.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
blood loss
Description
estimation of blood loss by venous sample and suction sample
Time Frame
1 year
Title
urine output
Description
detection of tissue perfusion by urine output every hour
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female patients aged between 21 to 60 years. American Society of Anesthesiologists (ASA) Ӏ& ӀӀ. Large volume liposuction. Exclusion Criteria: Any bleeding& coagulation disorders. Patients on regular anticoagulant or antiplatelet drugs. History of previous surgery in treated areas. Significant cardiopulmonary, hepatic or renal disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdel Wahed Ali, physician
Phone
+20 01065043864
Email
zamalek25590@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed shebl abdel ghany Elbrol, lecturer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdel Wahed Ali, physician
Organizational Affiliation
Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Gharbia
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanta University

12. IPD Sharing Statement

Citations:
Citation
Rajput RS, Das S, Chauhan S, Bisoi A, Vasdev S. Comparison of cardiac output measurement by noninvasive method with electrical cardiometry and invasive method with thermodilution technique in patients undergoing coronary artery bypass grafting. World Journal of Cardiovascular Surgery. 2014;2014
Results Reference
background
PubMed Identifier
16462322
Citation
Rohrich RJ, Leedy JE, Swamy R, Brown SA, Coleman J. Fluid resuscitation in liposuction: a retrospective review of 89 consecutive patients. Plast Reconstr Surg. 2006 Feb;117(2):431-5. doi: 10.1097/01.prs.0000201477.30002.ce.
Results Reference
background
PubMed Identifier
33409126
Citation
Kadafi KT, Latief A, Pudjiadi AH. Determining pediatric fluid responsiveness by stroke volume variation analysis using ICON(R) electrical cardiometry and ultrasonic cardiac output monitor: A cross-sectional study. Int J Crit Illn Inj Sci. 2020 Jul-Sep;10(3):123-128. doi: 10.4103/IJCIIS.IJCIIS_87_18. Epub 2020 Sep 22.
Results Reference
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Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula

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