Fluid Overload Clinical Trial
Official title:
Advanced Hemodynamic Monitoring in Free Flap Surgery
Background: Anesthesia in free flap surgery is challenging. Monitoring of hemodynamic
changes and their influence on the cardiovascular system in permanent feedback loops allow
control, which is what anesthesiologists aim for to ensure an adequate blood flow and tissue
oxygenation. The circulatory support and inferable volume administration are managed via
heart rate (HR) and mean arterial pressure (MAP), but both parameters are influenced by
variable components and are thus unfavorable for volume management. The aim of this study
was to evaluate whether volume requirement may be assumable to additional monitoring
parameters.
Methods: 31 patients were enrolled prospectively. HR, MAP, central venous pressure and O2
saturation were comprehended based on the protocols. We expanded the data set by a permanent
blinded intraoperative monitoring with registration of the Cardiac Index (CI) and Stroke
Volume Variation (SVV) and semi-invasive pulse-contour analysis utilizing the
Pro-AQT-Device.
We conducted a prospective cohort study in accordance with the WMA Declaration of Helsinki.
Standard general anesthesia with intubation and administration of sufentanil, propofol and
esmeron relaxant was performed in all patients undergoing primary free flap reconstruction
in course of a head and neck tumor reconstruction. Hemodynamic monitoring measurement of
cardiac index and the parameter stroke volume variation as surrogate for cardiac pre-load
was performed using a Pro-AQT Monitor. Using an arterial catheter previously set by the
Seldinger technique as part of the standard equipment, the mean, diastolic and systolic
arterial pressure was measured as part of the standard monitoring as presented. This tube
was previously deaerated and flushed with 2% NaCl and connected in series with a sensor,
which passes over electric line signals to the Pro-AQT-Monitor®. Based on previously entered
patient data and an analysis of the arterial pulse curve characteristics, a cardiac index
(CI) start-value is determined by the system. The sampling of the arterial pressure
characteristics is affected by a signal having a frequency of 250 Hz. The start value is the
basis for the further determination of HI trend values. The arterial pulse contour is
continuously tapped and analyzed and offset against the determined start value. To calculate
the cardiac index, the PICCO®-pulse contour algorithm is applied. Every 12 seconds, a new
measurement is performed and documented by the system.
From the read logs ProAQT Monitor® the values of the CI, MAP, HR, stroke volume index (SVI),
the stroke volume variation (SVV) and the systemic resistance index (SRI) were recorded at
different measurement intervals throughout the operation. All parameters were evaluated for
volume control in the course of the study.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Completed |
NCT05070819 -
Atrial Natriuretic Peptide in Assessing Fluid Status
|
N/A | |
| Withdrawn |
NCT04870073 -
Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery
|
Phase 3 | |
| Recruiting |
NCT02989051 -
Fluid Restriction Keeps Children Dry
|
Phase 2/Phase 3 | |
| Completed |
NCT00517127 -
Crystalloids Versus Colloids During Surgery
|
Phase 4 | |
| Completed |
NCT00852514 -
The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
|
Phase 4 | |
| Not yet recruiting |
NCT05983549 -
Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial
|
N/A | |
| Completed |
NCT03929471 -
Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
|
N/A | |
| Recruiting |
NCT06071026 -
Hemodynamic Effects of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy.
|
N/A | |
| Completed |
NCT02903316 -
Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles
|
N/A | |
| Terminated |
NCT02458157 -
Forced Fluid Removal in High Risk Acute Kidney Injury
|
Phase 4 | |
| Completed |
NCT02325856 -
Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients
|
N/A | |
| Completed |
NCT01628731 -
Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
|
Phase 3 | |
| Not yet recruiting |
NCT05647200 -
Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II
|
N/A | |
| Completed |
NCT03768752 -
Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients
|
||
| Terminated |
NCT03553394 -
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
|
N/A | |
| Completed |
NCT06097923 -
Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)
|
N/A | |
| Recruiting |
NCT04215692 -
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
|
N/A | |
| Not yet recruiting |
NCT03322410 -
Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
|
N/A |