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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01113073
Enrollment
20
Registered
2010-04-29
Start date
2010-01-31
Completion date
2010-09-30
Last updated
2010-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Responsiveness

Keywords

pulse pressure variation, hemodynamic monitoring, fluid responsiveness, mechanical ventilation, fluid therapy

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.

Interventions

OTHERventilatory protocol

Ventilatory protocol for short period with four different tidal volumes (12 min)

Placement of an elastic band around thorax to reduce thorax compliance

performing the passive leg raising test

Sponsors

Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
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).

Design outcomes

Primary

MeasureTime frameDescription
fluid responsiveness30 minutes around fluid challengepulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)

Secondary

MeasureTime frameDescription
Pressure distribution in thorax due to mechanical ventilation30 minutes of varying tidal volumesmechanical ventilation with 4 different tidal volumes and decreased chest compliance
Dynamic indices in pressure support ventilation30 minutes of pressure support
non invasive prediction of fluid responsiveness30 minutes around fluid challengepulse contour analysis of cardiac output with finger cuff combined with passive leg raising test
pressure distribution and dynamic indices during spontaneous breathing5 minutes of spontaneous breathing

Countries

Netherlands

Contacts

Primary ContactPeter Pickkers, MD, PhD
p.pickkers@ic.umcn.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026