Ventilator WeaningNCT00910286
Two Cycling Off Modes in Pressure Support: Study of Respiratory Mechanics, Breathing Comfort and Asynchrony Patterns
A study testing Pulmonary Ventilator in people with Ventilator Weaning and Respiration, Artificial, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Weaning, Respiration, Artificial
- What is being tested?
- Pulmonary Ventilator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients under PSV for more than 24 hours,
- Age > 18 years
- Ability to answer to a symptom visual analog scale (VAS)
Who cannot join
- Hemodynamic instability (use of vasoactive drugs like dopamine, dobutamine or norepinephrine)
- Bronchopleural fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VENTILAÇÃO MECÂNICA COM PRESSÃO SUPORTE: ESTUDO DA ASSINCRONIA EXPIRATÓRIA (in Portughese)
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.
Read the 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):
- Ventilatory parameters: PS (PSadjusted); measured PS (PSeffective) and PEEP (PEEPeffective); peak airway pressure; effective flow termination criterion (TC - V'ti/V'peak, %) .
- Breathing pattern: tidal volume obtained by mathematical integration of the flow signal; respiratory rate; minute ventilation; inspiratory time; expiratory time; duty cycle (Ti/Ttot); time constant obtained by measuring the slope off the expiratory limb of the flow-volume plot .
- Respiratory effort: pressure-time product required to ventilator trigger (PTPtrigger) ; inspiratory delivered assistance pressure-time products at 300 ms (PTPdelivered-assistance300) and 500 ms (PTPdelivered-assistance500) after the onset of inspiratory effort; over assistance pressure-time product (PTPover-assistance) (see Figure 2 for details); airway occlusion pressure at 0.1 second (P0.1) .
- Breathing comfort: evaluated by a modified VAS, labeled 0 to 10 (0 = best comfort and 10 = worst comfort) .
- Asynchrony patterns: ineffective efforts, both during inspiration and expiration, (IEinspiratory and IEexpiratory), double-triggering (D-T) and autotriggering (A-T) were detected by visual inspection of the flow and airway pressure signals recordings .
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.
- Conditions
- Ventilator Weaning, Respiration, Artificial
- Being tested
- Pulmonary Ventilator
- Keywords
- Pressure support ventilation, cycling off criteria, expiratory trigger, patient-ventilator interaction, patient comfort
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary VentilatorOther
Also called pressure support
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
| Study group | Role | What they receive |
|---|---|---|
| VENTILATOR WEANING | Other | 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. Receives: Other: Pulmonary Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
comfort
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventilator WeaningStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- josue a victorino, phd, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910286
- Sponsor's protocol ID
- Two cycling off modes in psv
- Status last verified
- May 2009
- First submitted
- 28 May 2009
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Du HL, Yamada Y. Expiratory asynchrony. Respir Care Clin N Am. 2005 Jun;11(2):265-80. doi: 10.1016/j.rcc.2005.02.001.
PubMed 15936693Hoff FC, Tucci MR, Amato MB, Santos LJ, Victorino JA. Cycling-off modes during pressure support ventilation: effects on breathing pattern, patient effort, and comfort. J Crit Care. 2014 Jun;29(3):380-5. doi: 10.1016/j.jcrc.2014.01.015. Epub 2014 Jan 29.
PubMed 24612764
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VENTILAÇÃO MECÂNICA COM PRESSÃO SUPORTE: ESTUDO DA ASSINCRONIA EXPIRATÓRIA (in Portughese)
- ClinicalTrials.gov ID
- NCT00910286
- Acronym / sponsor ID
- Two cycling off modes in psv
- Conditions
- Ventilator Weaning, Respiration, Artificial
- Keywords
- Pressure support ventilation, cycling off criteria, expiratory trigger, patient-ventilator interaction, patient comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Ventilatory parameters: PS (PSadjusted); measured PS (PSeffective) and PEEP (PEEPeffective); peak airway pressure; effective flow termination criterion (TC - V'ti/V'peak, %) .
- Breathing pattern: tidal volume obtained by mathematical integration of the flow signal; respiratory rate; minute ventilation; inspiratory time; expiratory time; duty cycle (Ti/Ttot); time constant obtained by measuring the slope off the expiratory limb of the flow-volume plot .
- Respiratory effort: pressure-time product required to ventilator trigger (PTPtrigger) ; inspiratory delivered assistance pressure-time products at 300 ms (PTPdelivered-assistance300) and 500 ms (PTPdelivered-assistance500) after the onset of inspiratory effort; over assistance pressure-time product (PTPover-assistance) (see Figure 2 for details); airway occlusion pressure at 0.1 second (P0.1) .
- Breathing comfort: evaluated by a modified VAS, labeled 0 to 10 (0 = best comfort and 10 = worst comfort) .
- Asynchrony patterns: ineffective efforts, both during inspiration and expiration, (IEinspiratory and IEexpiratory), double-triggering (D-T) and autotriggering (A-T) were detected by visual inspection of the flow and airway pressure signals recordings .
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 design
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VENTILATOR WEANING | Other | Other: Pulmonary VentilatorTwo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients under PSV for more than 24 hours,
- Age > 18 years
- Ability to answer to a symptom visual analog scale (VAS)
Key exclusion criteria (2 listed)
- Hemodynamic instability (use of vasoactive drugs like dopamine, dobutamine or norepinephrine)
- Bronchopleural fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary VentilatorAlso: pressure supportThe 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 | VENTILATOR WEANING |
Primary outcome
comfort
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
- Background: PubMed 15936693Du HL, Yamada Y. Expiratory asynchrony. Respir Care Clin N Am. 2005 Jun;11(2):265-80. doi: 10.1016/j.rcc.2005.02.001.
- Derived from this study: PubMed 24612764Hoff FC, Tucci MR, Amato MB, Santos LJ, Victorino JA. Cycling-off modes during pressure support ventilation: effects on breathing pattern, patient effort, and comfort. J Crit Care. 2014 Jun;29(3):380-5. doi: 10.1016/j.jcrc.2014.01.015. Epub 2014 Jan 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
josue a victorino, phd principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Ventilator in people with Ventilator Weaning and Respiration, Artificial, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comfort (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00910286, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2009.