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

R

Radboud University Medical Center

Status

Unknown

Conditions

Fluid Responsiveness

Treatments

Other: ventilatory protocol
Other: passive leg raising test
Other: Elastic band

Study type

Interventional

Funder types

Other

Identifiers

NCT01113073
UMCN_IC_BL_01/2010

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Elective open heart surgery
Experimental group
Description:
Patients who had undergone elective open heart surgery
Treatment:
Other: Elastic band
Other: passive leg raising test
Other: ventilatory protocol

Trial contacts and locations

1

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Central trial contact

Peter Pickkers, MD, PhD

Data sourced from clinicaltrials.gov

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