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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01113073
First received: April 22, 2010
Last updated: August 30, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Fluid Responsiveness
Other: ventilatory protocol
Other: Elastic band
Other: passive leg raising test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • fluid responsiveness [ Time Frame: 30 minutes around fluid challenge ] [ Designated as safety issue: No ]
    pulse pressure variation (PPV), systolic pressure variation (SPV), stroke volume variation (SVV), pre-ejection period variation (dPEP)


Secondary Outcome Measures:
  • Pressure distribution in thorax due to mechanical ventilation [ Time Frame: 30 minutes of varying tidal volumes ] [ Designated as safety issue: No ]
    mechanical ventilation with 4 different tidal volumes and decreased chest compliance

  • Dynamic indices in pressure support ventilation [ Time Frame: 30 minutes of pressure support ] [ Designated as safety issue: No ]
  • non invasive prediction of fluid responsiveness [ Time Frame: 30 minutes around fluid challenge ] [ Designated as safety issue: No ]
    pulse contour analysis of cardiac output with finger cuff combined with passive leg raising test

  • pressure distribution and dynamic indices during spontaneous breathing [ Time Frame: 5 minutes of spontaneous breathing ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elective open heart surgery
Patients who had undergone elective open heart surgery
Other: ventilatory protocol
Ventilatory protocol for short period with four different tidal volumes (12 min)
Other: Elastic band
Placement of an elastic band around thorax to reduce thorax compliance
Other: passive leg raising test
performing the passive leg raising test

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01113073

Contacts
Contact: Peter Pickkers, MD, PhD p.pickkers@ic.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands
Contact: Peter Pickkers, MD, PhD       p.pickkers@ic.umcn.nl   
Principal Investigator: Peter Pickker, MD, PhD         
Sub-Investigator: Benno Lansdorp, MSc.         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Benno Lansdorp, MSc. Radboud University
  More Information

No publications provided

Responsible Party: P. Pickkers MD, PhD, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT01113073     History of Changes
Other Study ID Numbers: UMCN_IC_BL_01/2010
Study First Received: April 22, 2010
Last Updated: August 30, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
pulse pressure variation
hemodynamic monitoring
fluid responsiveness
mechanical ventilation
fluid therapy

ClinicalTrials.gov processed this record on October 23, 2014