LipodystrophyNCT05402982
Intraoperative Fluid Management of Liposuction , Cardiometry Versus Rohrich Formula
A study testing Electrical Cardiometry (EC) ICON and Rohrich formula in people with Lipodystrophy, run by Ahmed Abdel Wahed Ali at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophy
- What is being tested?
- Electrical Cardiometry (EC) ICON and Rohrich formula
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female patients aged between 21 to 60 years.
- American Society of Anesthesiologists (ASA) Ӏ\& ӀӀ.
- Large volume liposuction.
Who cannot join
- Any bleeding\& coagulation disorders.
- Patients on regular anticoagulant or antiplatelet drugs.
- History of previous surgery in treated areas.
- Significant cardiopulmonary, hepatic or renal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Fluid Management of Large Volume Liposuction Surgery , Cardiometry Guided Stroke Volume Variation Versus Rohrich Formula
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 .
Read the 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.
- Conditions
- Lipodystrophy
- Being tested
- Electrical Cardiometry (EC) ICON, Rohrich formula
- Keywords
- Lipodystrophy
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Cardiometry (EC) ICONDevice
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
Rohrich formulaOther
Rohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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% . Receives: Device: Electrical Cardiometry (EC) ICON |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure
Mean arterial blood pressure at 4 litre aspiration of fat and at every litre aspirated after.
Measured: 1 year
Secondary outcomes (2)
blood loss
estimation of blood loss by venous sample and suction sample
Measured: 1 year
urine output
detection of tissue perfusion by urine output every hour
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start25 Jun 2022
- Primary completion10 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Abdel Wahed Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Ahmed Abdel Wahed Ali, Tanta University
- Investigators
- Ahmed Abdel Wahed Ali, physician, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402982
- Sponsor's protocol ID
- fluid status of liposuction
- Status last verified
- Nov 2023
- First submitted
- 20 May 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
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.
PubMed 16462322Kadafi 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.
PubMed 33409126
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fluid Management of Large Volume Liposuction Surgery , Cardiometry Guided Stroke Volume Variation Versus Rohrich Formula
- ClinicalTrials.gov ID
- NCT05402982
- Acronym / sponsor ID
- fluid status of liposuction
- Conditions
- Lipodystrophy
- Keywords
- Lipodystrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ahmed Abdel Wahed AliUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 10 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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% .
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Other | Other: Rohrich formulaFluid 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 | Other | Device: Electrical Cardiometry (EC) ICONPatients 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% . |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female patients aged between 21 to 60 years.
- American Society of Anesthesiologists (ASA) Ӏ\& ӀӀ.
- Large volume liposuction.
Key exclusion criteria (4 listed)
- Any bleeding\& coagulation disorders.
- Patients on regular anticoagulant or antiplatelet drugs.
- History of previous surgery in treated areas.
- Significant cardiopulmonary, hepatic or renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical Cardiometry (EC) ICONElectrical 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 | Device | GROUP B |
| Rohrich formulaRohrich formula and the intraoperative fluid ratio (subcutaneous infiltration fluid plus intravenous fluid divided by total aspirate volume) will be 1.2 | Other | GROUP A |
Primary outcome
Mean arterial blood pressure
Time frame: 1 year
Mean arterial blood pressure at 4 litre aspiration of fat and at every litre aspirated after.
2 secondary outcomes
blood loss
Time frame: 1 year
urine output
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- BackgroundRajput 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: PubMed 16462322Rohrich 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.
- Background: PubMed 33409126Kadafi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Abdel Wahed Ali, physician principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Cardiometry (EC) ICON and Rohrich formula in people with Lipodystrophy, run by Ahmed Abdel Wahed Ali at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402982, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.