Slope of the Pressure-Time Waveform Predicts Resistance and Compliance in Mechanically Ventilated Subjects
Recruitment status was Recruiting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Slope of the Pressure-Time Waveform Predicts Respiratory System Resistance and Elastance in Mechanically Ventilated Subjects|
- Outcome measure: resistance and compliance measured during pressure control versus volume control ventilation [ Time Frame: duration of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2007|
|Estimated Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
During volume assist-control ventilation, a 0.4 second end-inspiratory pause will be set and the following pressures measured: peak pressure; plateau pressure; and PEEP. The following ventilator settings will be recorded: inspiratory flow; expired tidal volume; and rate. The presence or absence of autoPEEP will be noted.
During pressure-control ventilation, the flow versus time waveform will be printed from the ventilator using a conventional computer printer for later analysis. The following ventilator settings will be recorded: inspiratory pressure; PEEP; and expired tidal volume.
Aim 1: To compare the respiratory system resistance and elastance obtained during constant-flow, volume-preset ventilation (using conventional means) and during pressure-preset ventilation (by analyzing the slope of the flow versus time waveform, as described below).
Aim 2: To determine whether patient effort and level of alertness impair the accuracy of resistance and elastance measurements during pressure-preset ventilation.
Hypothesis 1: Our primary hypothesis is that the flow versus time waveform contains information sufficient to calculate the respiratory system resistance and elastance. To test the primary hypothesis, we propose to measure resistance and elastance of subjects ventilated in the ICU during assist-control ventilation (a standard constant flow, volume-preset mode). Then we will record the flow versus time waveform during pressure-preset ventilation. By extrapolating the flow versus time waveform (which is generally linear) to the time axis, one can calculate elastance since at zero flow, the alveolar pressure equals the ventilator inspiratory pressure. Then Ers = (Pinsp - Total PEEP)/Extrapolated VT, where Pinsp is the set inspiratory pressure and extrapolated VT is the tidal volume if inspiratory time had been sufficient to allow equilibration between patient and ventilator (using trigonometry). Similarly, by extrapolating the flow versus time waveform to the flow axis (to find the maximal flow), one can calculate the resistance, assuming that flow depends on the pressure difference between ventilator and patient and the square of the resistance. We will compare the values derived during pressure-preset ventilation with those determined during assist-control (taken as the true values).
Hypothesis 2: We hypothesize that inspiratory effort will be sufficient in some subjects to distort the flow versus time waveform from that which would be seen if the patient were passive, leading to erroneous values for resistance and elastance. We will estimate the respiratory drive using a standard measure, the fall in Pao during a brief inspiratory occlusion 100ms following the onset of inspiration (P0.1). Further, we will measure each subject's alertness on the Richmond Agitation-Sedation Scale (RASS). We expect our estimations of resistance and elastance to less accurate (during pressure-preset ventilation compared with assist-control) in subjects with greater respiratory drive and higher levels of alertness.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750074
|Contact: Greg A Schmidt, MDfirstname.lastname@example.org|
|United States, Iowa|
|Univesity of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Gregory A. Schmidt, MD 319-384-6746 email@example.com|
|Sub-Investigator: Nicole D. Collett, MD|