Clinical trial NCT01113073: The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation
Official title: The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fluid Responsiveness
Keywords: pulse pressure variation
hemodynamic monitoring
fluid responsiveness
mechanical ventilation
fluid therapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-04-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Fluid administration is a daily intervention on the intensive care unit to improve cardiac output (CO) and stabilize circulation in critically ill patients. Simultaneously, the volume status of the patient is very difficult to assess. Too little volume leads to inadequate organ perfusion followed by ischemia and organ failure. Too much volume may worsen heart failure and cause pulmonary and peripheral edema and contribute to further tissue injury and organ dysfunction. Although dynamic indices have been shown to be more accurate predictors of fluid responsiveness, this relevant and complex task is usually guided by static clinical variables and the specialist's interpretation due to the fact that the interpretation of dynamic parameters is not fully developed and that they are not universally available. This lack of understanding is partially because of the complex interaction with mechanical ventilation. The investigators hypothesize that knowing the distribution of ventilatory pressures will make it possible to index dynamic parameters to tidal volume and improve their predictive value concerning the volume status of the patient. In addition, it would be of interest to be able to predict fluid responsiveness in a non-invasive way, especially in critically ill patients. Up to now, continuous non-invasive cardiac output monitoring using Nexfin in critically ill patients has not been validated and also not tested for its ability to predict fluid responsiveness. The present research proposal evaluates the possibility and accuracy of the model flow analysis obtained by non-invasive finger arterial pressure measurements to determine fluid responsiveness using passive leg raising. It will also be compared to a more invasive method (that is currently used in the clinic) to assess its ability to measure absolute CO levels accurately. It may make it possible to assess fluid responsiveness in a non-invasive and patient friendly way.


Eligibility criteria: Inclusion Criteria:

* Elective open heart surgery.

Exclusion Criteria:

* Significant cardiac arrhythmias, including atrial fibrillation.
* Hemodynamical instability, as defined by a variation in heart rate, blood pressure and cardiac output of more than 10% during the 15-min period before starting the protocol.
* Recent myocardial infarction (\< 3 mnd, troponine \> 50 ug/l).

Primary outcomes:
measure: fluid responsiveness
timeFrame: 30 minutes around fluid challenge
Secondary outcomes:
measure: Pressure distribution in thorax due to mechanical ventilation
timeFrame: 30 minutes of varying tidal volumes
measure: Dynamic indices in pressure support ventilation
timeFrame: 30 minutes of pressure support
measure: non invasive prediction of fluid responsiveness
timeFrame: 30 minutes around fluid challenge
measure: pressure distribution and dynamic indices during spontaneous breathing
timeFrame: 5 minutes of spontaneous breathing
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Benno Lansdorp, MSc.
role: PRINCIPAL_INVESTIGATOR
References: