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Clinical Trials/NCT01113073
NCT01113073UnknownNot Applicable

The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation

Radboud University Medical Center1 site in 1 country20 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
fluid responsiveness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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).

Arms & Interventions

Elective open heart surgery

Experimental

Patients who had undergone elective open heart surgery

Intervention: Elastic band (Other)

Elective open heart surgery

Experimental

Patients who had undergone elective open heart surgery

Intervention: passive leg raising test (Other)

Elective open heart surgery

Experimental

Patients who had undergone elective open heart surgery

Intervention: ventilatory protocol (Other)

Outcomes

Primary Outcomes

fluid responsiveness

Time Frame: 30 minutes around fluid challenge

pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)

Secondary Outcomes

  • Pressure distribution in thorax due to mechanical ventilation(30 minutes of varying tidal volumes)
  • Dynamic indices in pressure support ventilation(30 minutes of pressure support)
  • non invasive prediction of fluid responsiveness(30 minutes around fluid challenge)
  • pressure distribution and dynamic indices during spontaneous breathing(5 minutes of spontaneous breathing)

Investigators

Sponsor Class
Other

Study Sites (1)

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