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Sponsored by: |
Hospital de Clinicas de Porto Alegre |
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Information provided by: | Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT00910286 |
Objective: To compare termination criteria (TC) of pressure support ventilation (PSV).
Design: Randomized cross-over clinical trial.
Setting: Intensive Care Units.
Patients: Sixteen patients on PSV with ability to answer a visual analog scale (VAS).
Protocol and Measurements: Each patient was ventilated with two different TC ventilators, fixed and automatic, with measurements of ventilatory mechanic variables, breathing comfort and asynchrony patterns.
Condition | Intervention |
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Ventilator Weaning Respiration, Artificial |
Other: Pulmonary Ventilator |
Study Type: | Interventional |
Study Design: | Single Blind (Subject), Uncontrolled, Crossover Assignment |
Official Title: | VENTILAÇÃO MECÂNICA COM PRESSÃO SUPORTE: ESTUDO DA ASSINCRONIA EXPIRATÓRIA (in Portughese) |
Enrollment: | 18 |
Study Start Date: | December 2004 |
Study Completion Date: | June 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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VENTILATOR WEANING
Two ventilators with different flow termination criteria (TC) were compared: Servo 300 (Siemens-Elema, Sweden) with fixed TC (5% of peak inspiratory flow) and Newport E500 (Newport Medical Instruments, CA) with automatic TC (varies between 5% to 55%). Each patient remained three hours in the protocol, one hour in each ventilator, after been randomized to one of two sequences of 3 steps: Fixed 5% / Automatic / Fixed 5% or Automatic / Fixed 5% / Automatic . The PS, the positive end expiratory pressure (PEEP), the inspiratory oxygen fraction (FiO2) and the pressure trigger sensitivity levels were unchanged during the protocol.
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Other: Pulmonary Ventilator
The aim of the present study was to compare two different cycling off modes in PSV, a fixed and other automatic, about ventilatory mechanic variables, breathing comfort and patient-ventilator asynchrony patterns
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Two ventilators with different flow termination criteria (TC) were compared: Servo 300 (Siemens-Elema, Solna, Sweden) with fixed TC (5% of peak inspiratory flow) and Newport E500 (Newport Medical Instruments, Costa Mesa, CA) with automatic TC (varies between 5% to 55%). Each patient remained three hours in the protocol, one hour in each ventilator, after been randomized to one of two sequences of 3 steps: Fixed 5% / Automatic / Fixed 5% or Automatic / Fixed 5% / Automatic (Figure 1). The transition among the ventilators was realized through a three-way flow directional valve (Three-Way T-Shape TM, Hans Rudolph Incorporation, Kansas City, EUA).
The PS level was determined by clinical staff to partially unload the respiratory muscle without respiratory distress based on observation of the patient's breathing pattern. The PS, the positive end expiratory pressure (PEEP), the inspiratory oxygen fraction (FiO2) and the pressure trigger sensitivity levels were unchanged during the protocol.
Study variables: Patients' demographic, anthropometric and clinical data were obtained (Table 1).
The study variables were detected noninvasively using only airway pressure (Paw) and flow signals, obtained with a pressure differential pneumotachometer (CO2SMO Plus; Novametrix Medical Systems, Wallingford, CT) located at the distal end of the ventilator circuit . Three records of five minutes were realized in each study step: time = 0' (0-5 min), t = 30' (30-35 min) and t = 55' (55-60 min). Data were digitalized at 100 Hz and recorded on a personal computer for subsequent analysis (LabVIEW 7.1, National Instruments Corporation, Austin, TX). A total of nine record phases of five minutes from each patient were analyzed .The variables values were obtained by one hundred ventilatory cycles from each recorded phase
Measured variables:
The following variables were analyzed (detailed descriptions of each one were in the Electronic Supplementary
Material - ESM):
Statistical Analysis:
The statistical analysis was performed using the Statistical Package for Social Science (SPSS 15.0, Chicago, EUA) and the significance level was established as p < 0.05. Tests are detailed in the ESM.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:.
Brazil, RS | |
Hospital Mae De Deus | |
porto alegre, RS, Brazil, 91900580 |
Principal Investigator: | josue a victorino, phd | Hospital de Clinicas de Porto Alegre |
Principal Investigator: | josue a victorino, phd | Hospital de Clinicas de Porto Alegre |
Responsible Party: | hospital mae deus ( josue almeida victorino ) |
Study ID Numbers: | Two cycling off modes in psv |
Study First Received: | May 28, 2009 |
Last Updated: | May 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00910286 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
Pressure support ventilation cycling off criteria expiratory trigger patient-ventilator interaction patient comfort |