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

NCT ID: NCT01113073

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fluid Responsiveness

Keywords

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pulse pressure variation hemodynamic monitoring fluid responsiveness mechanical ventilation fluid therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Elective open heart surgery

Patients who had undergone elective open heart surgery

Group Type EXPERIMENTAL

ventilatory protocol

Intervention Type OTHER

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

Elastic band

Intervention Type OTHER

Placement of an elastic band around thorax to reduce thorax compliance

passive leg raising test

Intervention Type OTHER

performing the passive leg raising test

Interventions

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ventilatory protocol

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

Intervention Type OTHER

Elastic band

Placement of an elastic band around thorax to reduce thorax compliance

Intervention Type OTHER

passive leg raising test

performing the passive leg raising test

Intervention Type OTHER

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Radboud University Nijmegen Medical Centre

Principal Investigators

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Benno Lansdorp, MSc.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Peter Pickkers, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Peter Pickkers, MD, PhD

Role: primary

Other Identifiers

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UMCN_IC_BL_01/2010

Identifier Type: -

Identifier Source: org_study_id