Two Cycling Off Modes in Pressure Support: Study of Respiratory Mechanics, Breathing Comfort and Asynchrony Patterns
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 28, 2009 | ||||
| Last Updated Date | May 28, 2009 | ||||
| Start Date ICMJE | December 2004 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
comfort [ Time Frame: 30 minutes ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Two Cycling Off Modes in Pressure Support: Study of Respiratory Mechanics, Breathing Comfort and Asynchrony Patterns | ||||
| Official Title ICMJE | VENTILAÇÃO MECÂNICA COM PRESSÃO SUPORTE: ESTUDO DA ASSINCRONIA EXPIRATÓRIA (in Portughese) | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | 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
Other Names:
|
||||
| Study Arm (s) | 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.
Intervention: Other: Pulmonary Ventilator |
||||
| Publications * | Du HL, Yamada Y. Expiratory asynchrony. Respir Care Clin N Am. 2005 Jun;11(2):265-80. Review. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 18 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:.
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00910286 | ||||
| Other Study ID Numbers ICMJE | Two cycling off modes in psv | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | josue almeida victorino, hospital mae deus | ||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||
| Verification Date | May 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||