Hypovolemia Clinical Trial
Official title:
Evaluation of Hemodynamic Changes Induced by Alveolar Recruitment Maneuver With Respect to Volemic State in Patients Undergoing Anesthesia for Colon Surgery
Intraoperative hemodynamic management is important, since even mild variations in circulatory
volume can be extremely damaging for patients.
Minimally invasive hemodynamic monitoring are not always available or cost-effective,
therefore management of fluids is challenging for anesthesiologists.
This study aims to assess if, after performance of a lung recruitment maneuver (LRM),
standard parameter's variation differs between hypovolemic and normovolemic patients.
Patients' volemic state will be assessed with the Vigileo system. Standard monitoring values
(heart rate, invasive blood pressure and saturation) will be registered before and after
LRMs.
A fluid challenge will be performed and the above mentioned parameters will be recorded
again, after a second LRM.
The study is a prospective observational study.
During general anesthesia, it's important to maintain normovolemia, since hypovolemia can
cause inadequate tissue perfusion and hypervolemia increases the rate of complications,
overall mortality and morbidity.
Critically ill patients commonly present with important hypotension that, in the majority of
cases, is promptly treated with intravenous fluids to reverse organ hypoperfusion.
However, previous studies have demonstrated that only 50% of hemodynamically unstable
patients are responsive to fluid administration.
In the last decade, attention has been focused on finding a parameter capable of assessing
fluid responsiveness in a hypotensive patient.
Recent articles have demonstrated that standard monitoring parameters have no significance
for this purpose, while hemodynamic parameters, like stroke volume variation (SVV) or pulse
pressure variation (PVV) may have an important role.
An interesting field of research involves heart-lung interactions during mechanical
ventilation. In particular, lung recruitment maneuver (LRM) induce physiological
cardiovascular alterations and may have a correlation with the volemic state of the patient.
LRMs are commonly performed and safe procedures that consist in application of a continuous
positive pressure in the lungs of mechanically ventilated patient, with the aim of improving
pulmonary compliance.
The goal of our study is to verify whether the alterations induced by lung recruitment
maneuver on commonly registered intraoperative parameters, such as heart rate and arterial
blood pressure, actually differ when the maneuver is applied to hypovolemic and normovolemic
patients respectively.
Patients undergoing scheduled laparoscopic colon surgery will be enrolled. Informed consent
will be obtained during the preoperative anesthesiological visit.
General anaesthesia will be managed according to standard clinical practice. Invasive blood
pressure monitoring will be started with a peripheral arterial catheter and hemodynamic
parameters (SVV and CO) will be monitored through the Vigileo device.
During the resection phase, the patient has to be maintained in hypovolemic conditions. When
SVV reaches a value of 12-15%, a LRM is performed, consisting in the application of 30 cm H2O
continuous positive airway pressure for 30 seconds.
Standard monitoring values (heart rate, invasive blood pressure and saturation) will be
registered.
Thereafter, a fluid challenge will be performed, consisting in intravenous administration of
8 ml/kg of saline solution over 20 minutes. As soon as SVV will reach a value of 10%, LRM
will be performed again and the abovementioned three sets of measurements will be carried out
once again.
As standard management of LRM, the maneuver will be stopped if the heart rate would lower
below 35 bpm or the systolic blood pressure would lower below 60 mmHg.
The information provided by the study is of interest in cases in which the deployment of
sophisticated monitoring, as the Vigileo system, is not feasible or cost-effective. In this
way, hemodynamic management during major surgeries would become faster and easier, relying on
traditional monitoring.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
NCT02315937 -
Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography'
|
N/A | |
Active, not recruiting |
NCT01681238 -
Goal-directed Therapy in High-risk Surgery
|
N/A | |
Completed |
NCT01210417 -
Trauma Heart to Arm Time
|
N/A | |
Recruiting |
NCT05557461 -
Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?
|
||
Withdrawn |
NCT03246425 -
Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study
|
N/A | |
Completed |
NCT02721654 -
Plasma-Lyte 148® versUs Saline Study
|
Phase 4 | |
Completed |
NCT02903316 -
Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles
|
N/A | |
Completed |
NCT03009305 -
Cerebral Oximetry in Lower Body Negative Pressure
|
N/A | |
Completed |
NCT01456559 -
Detection of Hypovolemia Using Pleth Variability Index (PVI)
|
N/A | |
Completed |
NCT00380107 -
Volume Deficit Prior to Surgery
|
Phase 4 | |
Recruiting |
NCT06123039 -
Use of Heart-lung Interaction to Predict Haemodynamic Tolerance to the Open Lung Approach With Individualised PEEP
|
||
Completed |
NCT04573842 -
Ultrasound Assessment of the Subclavian Vein for Predicting Hypotension in Children After Anaesthesia Induction
|
||
Completed |
NCT05150418 -
Supplemental Oxygen in Hypovolemia
|
Phase 1 | |
Completed |
NCT02961439 -
Validation of Epworth Richmond's Echocardiography Education Focused Year
|
N/A | |
Completed |
NCT01535703 -
Comparison of Cardiac Output Measurement Between Transpulmonary Thermodilution and Photoplethysmography
|
N/A | |
Completed |
NCT01010022 -
Trial of 6% HES130/0.4
|
Phase 3 | |
Completed |
NCT04641949 -
Methoxyflurane and Fentanyl in LBNP
|
Phase 4 | |
Recruiting |
NCT03592290 -
Hemodynamics Monitoring During Lower Body Negative Pressure (LBNP) Induced Controlled Hypovolemia
|
||
Suspended |
NCT03736421 -
Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
|
||
Completed |
NCT02679625 -
Comparison of Non-Invasive Methods of Assessing Fluid Responsiveness in ED and ICU Patients
|