Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula

NCT05402982 | Completed DMC

• 1 other identifier: fluid status of liposuction
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Lipodystrophy

Keywords

Lipodystrophy

Outcome Measures

Primary Outcomes (1)

• Mean arterial blood pressure

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

  1 year

Secondary Outcomes (2)

• blood loss

  1 year

• urine output

  1 year

Study Arms (2)

GROUP A

OTHER

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).

Other: Rohrich formula

GROUP B

OTHER

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% .

Device: Electrical Cardiometry (EC) ICON

Interventions

Electrical Cardiometry (EC) ICON DEVICE

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

GROUP B

Rohrich formula OTHER

Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2

GROUP A

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ahmed Abdel Wahed Ali: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 16462322 BACKGROUND

• 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.

  PMID: 33409126 BACKGROUND

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ahmed Abdel Wahed Ali, physician

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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% .

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: June 2, 2022
• Study Start: June 25, 2022
• Primary Completion: June 10, 2023
• Study Completion: July 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

EG (1)