The Distribution of Pressure in the Thorax During Mechanical Ventilation and Its Effects on the Circulation
Recruitment status was Recruiting
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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 |
- 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)
- 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 |
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| Contact: Peter Pickkers, MD, PhD | p.pickkers@ic.umcn.nl |
| 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. | |
| 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 June 18, 2013