Infections, RespiratoryNCT03631342
Comparison Between Different Ventilator Hyperinflation Maneuvers
A study testing VCV20, VCV40 and PCV in people with Infections, Respiratory and Ventilator Associated Pneumonia, run by Brazilian Institute of Higher Education of Censa at 1 site in Brazil.
Trial summary
The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Respiratory, Ventilator Associated Pneumonia
- What is being tested?
- VCV20, VCV40 and PCV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Mar 2017to 23 May 2018
- 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
- Pulmonary infection
- Mechanically ventilated for more than 96 hours through pressure-assisted ventilation (PSV) or pressure-controlled ventilation (PCV)
- Static compliance between 30 and 70 mL/cmH2O
- PEEP between 5 and 8 cmH2O.
Who cannot join
- Hemodynamic instability
- Non-drained pleural effusion or pneumothorax
- Intracranial hypertension
- Bronchospasm
- Adult respiratory distress syndrome (ARDS)
- Decompensated congestive heart failure
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Luciano M Chicayban
Campos dos Goytacazes, Rio de Janeiro, 28015150
About this study
The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated.
Read the detailed description
PURPOSE: To compare different ways of applying ventilator hyperinflation. METHODS: A randomized crossover clinical trial was performed with 30 patients (66.5 ± 17.3 years) with hypersecretion. The ventilator hyperinflation was performed in five ventilatory modalities for five minutes, with an interval of 2 hours, the order being determined by randomization: controlled ventilation at volume (VCV) with constant flow of 20 (VCV20) Lpm and 40 Lpm (VCV40), controlled ventilation pressure ventilation (PCV), controlled pressure ventilation associated with inspiratory time adjustment (PCV + Tins) and support pressure ventilation (PSV). In VCV mode, the volume was increased every 50mL, until reaching a maximum pressure of 40cmH2O. In the pressure controlled modes, the inspiratory pressure was increased every 5 cmH2O until the total pressure reached 40 cmH2O. The inspiratory time was adjusted so that the inspiratory flow reached the baseline. The following variables were evaluated: tidal volume, inspiratory time (Tins), mean airway pressure (Pmean), peak inspiratory flow (PIFR) and expiratory flow (PEFR), PIFR / PEFR and Bias Flow (PEFR-PIFR).
- Being tested
- VCV20, VCV40, PCV, PCV+Tins, PSV
- Keywords
- Ventilator Hyperinflation, Physical Therapy, Mechanical Ventilation
- Medical subject headings
- Respiratory Tract Infections, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCV20Other
controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
VCV40Other
volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
PCVOther
controlled ventilation mode, 1 second inspiratory time. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O.
PCV+TinsOther
controlled ventilation and inspiratory pressure was increased every 5 cmH2O until the maximum pressure was 40 cmH2O. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP.
PSVOther
ventilatory mode with pressure support, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients.
| Study group | Role | What they receive |
|---|---|---|
| VCV20 | Experimental | Volume-controlled ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O. Receives: Other: VCV20 |
| VCV40 | Experimental | Volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O. Receives: Other: VCV40 |
| PCV | Experimental | Pressure controlled ventilation mode, inspiratory time of 1 second. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O. Receives: Other: PCV |
| PCV+Tins | Experimental | Pressure controlled ventilation mode and inspiratory pressure was increased every 5cmH2O, until the maximum pressure of 40 cmH2O was reached. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. Receives: Other: PCV+Tins |
| PSV | Experimental | Pressure support ventilation mode, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients. Receives: Other: PSV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory Volume
Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O
Measured: Five minutes after the onset of intervention
Inspiratory time
inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality
Measured: Five minutes after the onset of intervention
Mean Pressure
airway mean pressure measured on the mechanical ventilator in 2 cycles
Measured: Five minutes after the onset of intervention
Peak Expiratory Flow
maximal expiratory flow in 2 cycles
Measured: Five minutes after the onset of intervention
Peak Inspiratory Flow
Maximal inspiratory flow in 2 cycles
Measured: Five minutes after the onset of intervention
PIFR/PEFR
Peak inspiratory to expiratory flow ratio
Measured: Five minutes after the onset of intervention
Bias Flow
Difference between peak inspiratory and expiratory flows
Measured: Five minutes after the onset of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start18 Mar 2017
- Primary completion30 Sep 2017
- Study completion23 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, RespiratoryStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In order to perform both interventions, the patients were placed in dorsal decubitus with a head elevated at 45 ° and submitted to closed tracheal aspiration, according to the recommendations of the American Association for Respiratory Care. In addition, the bacteriological filter was changed, the cuff pressure was increased and the presence of leaks in the mechanical fan circuits was verified. All patients underwent five hyperinflation maneuvers, the order being determined by randomization. Controlled volume ventilation (VCV) at a constant flow rate of 20 Lpm (VCV-20) and 40 Lpm (VCV-40), controlled pressure ventilation (VCV-40) was performed for 2 minutes at 10 minute intervals. PCV), pressure-controlled ventilation associated with inspiratory time adjustment (PCV + Tins) and pressure-supported ventilation (PSV). PEEP and FiO2 were maintained throughout the study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brazilian Institute of Higher Education of Censa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciano Matos Chicayban, Brazilian Institute of Higher Education of Censa
- Investigators
- LUCIANO M CHICAYBAN, MSc, Principal investigator, Brazilian Institute of Higher Education of Censa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631342
- Sponsor's protocol ID
- VHI Modality
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Different Ventilator Hyperinflation Maneuvers
- ClinicalTrials.gov ID
- NCT03631342
- Acronym / sponsor ID
- VHI Modality
- Keywords
- Ventilator Hyperinflation, Physical Therapy, Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brazilian Institute of Higher Education of CensaUniversity, hospital or other
- Study start
- 18 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 15 Aug 2018 (actual)
- 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.
The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated.
Detailed description
PURPOSE: To compare different ways of applying ventilator hyperinflation. METHODS: A randomized crossover clinical trial was performed with 30 patients (66.5 ± 17.3 years) with hypersecretion. The ventilator hyperinflation was performed in five ventilatory modalities for five minutes, with an interval of 2 hours, the order being determined by randomization: controlled ventilation at volume (VCV) with constant flow of 20 (VCV20) Lpm and 40 Lpm (VCV40), controlled ventilation pressure ventilation (PCV), controlled pressure ventilation associated with inspiratory time adjustment (PCV + Tins) and support pressure ventilation (PSV). In VCV mode, the volume was increased every 50mL, until reaching a maximum pressure of 40cmH2O. In the pressure controlled modes, the inspiratory pressure was increased every 5 cmH2O until the total pressure reached 40 cmH2O. The inspiratory time was adjusted so that the inspiratory flow reached the baseline. The following variables were evaluated: tidal volume, inspiratory time (Tins), mean airway pressure (Pmean), peak inspiratory flow (PIFR) and expiratory flow (PEFR), PIFR / PEFR and Bias Flow (PEFR-PIFR).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- In order to perform both interventions, the patients were placed in dorsal decubitus with a head elevated at 45 ° and submitted to closed tracheal aspiration, according to the recommendations of the American Association for Respiratory Care. In addition, the bacteriological filter was changed, the cuff pressure was increased and the presence of leaks in the mechanical fan circuits was verified. All patients underwent five hyperinflation maneuvers, the order being determined by randomization. Controlled volume ventilation (VCV) at a constant flow rate of 20 Lpm (VCV-20) and 40 Lpm (VCV-40), controlled pressure ventilation (VCV-40) was performed for 2 minutes at 10 minute intervals. PCV), pressure-controlled ventilation associated with inspiratory time adjustment (PCV + Tins) and pressure-supported ventilation (PSV). PEEP and FiO2 were maintained throughout the study.
| Arm | Type | Receives |
|---|---|---|
| VCV20 | Experimental | Other: VCV20Volume-controlled ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O. |
| VCV40 | Experimental | Other: VCV40Volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O. |
| PCV | Experimental | Other: PCVPressure controlled ventilation mode, inspiratory time of 1 second. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O. |
| PCV+Tins | Experimental | Other: PCV+TinsPressure controlled ventilation mode and inspiratory pressure was increased every 5cmH2O, until the maximum pressure of 40 cmH2O was reached. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. |
| PSV | Experimental | Other: PSVPressure support ventilation mode, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pulmonary infection
- Mechanically ventilated for more than 96 hours through pressure-assisted ventilation (PSV) or pressure-controlled ventilation (PCV)
- Static compliance between 30 and 70 mL/cmH2O
- PEEP between 5 and 8 cmH2O.
Key exclusion criteria (6 listed)
- Hemodynamic instability
- Non-drained pleural effusion or pneumothorax
- Intracranial hypertension
- Bronchospasm
- Adult respiratory distress syndrome (ARDS)
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 |
|---|---|---|
| VCV20controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O. | Other | VCV20 |
| VCV40volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O. | Other | VCV40 |
| PCVcontrolled ventilation mode, 1 second inspiratory time. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O. | Other | PCV |
| PCV+Tinscontrolled ventilation and inspiratory pressure was increased every 5 cmH2O until the maximum pressure was 40 cmH2O. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. | Other | PCV+Tins |
| PSVventilatory mode with pressure support, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients. | Other | PSV |
Primary outcome
Inspiratory Volume
Time frame: Five minutes after the onset of intervention
Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O
Inspiratory time
Time frame: Five minutes after the onset of intervention
inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality
Mean Pressure
Time frame: Five minutes after the onset of intervention
airway mean pressure measured on the mechanical ventilator in 2 cycles
Peak Expiratory Flow
Time frame: Five minutes after the onset of intervention
maximal expiratory flow in 2 cycles
Peak Inspiratory Flow
Time frame: Five minutes after the onset of intervention
Maximal inspiratory flow in 2 cycles
PIFR/PEFR
Time frame: Five minutes after the onset of intervention
Peak inspiratory to expiratory flow ratio
Bias Flow
Time frame: Five minutes after the onset of intervention
Difference between peak inspiratory and expiratory flows
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 15 Aug 2018.
- Individual participant dataSharing planned: No
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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.
LUCIANO M CHICAYBAN, MSc principal investigator
Brazilian Institute of Higher Education of Censa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VCV20, VCV40 and PCV in people with Infections, Respiratory and Ventilator Associated Pneumonia, run by Brazilian Institute of Higher Education of Censa 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 4 inclusion and 6 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 15 Aug 2018. 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?
Inspiratory Volume (time frame: Five minutes after the onset of intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2018.