Pulmonary AtelectasisNCT03630484
Ventilator Hyperinflation and Manual Rib Cage Compression
A study testing Expiratory Rib Cage Compression and Compression + Ventilator Hyperinflation in people with Pulmonary Atelectasis, run by Brazilian Institute of Higher Education of Censa.
Trial summary
This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- Expiratory Rib Cage Compression and Compression + Ventilator Hyperinflation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2014to 11 Jul 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients under mechanical ventilation
- diagnosis of pulmonary infection
- hypersecretive
Who cannot join
- haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
- acute bronchospasm
- acute respiratory distress syndrome
- untreated pneumothorax
About this study
Official title: Comparison Between Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial
This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.
Read the detailed description
Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.
- Conditions
- Pulmonary Atelectasis
- Being tested
- Expiratory Rib Cage Compression, Compression + Ventilator Hyperinflation
- Keywords
- Ventilator Hyperinflation, Expiratory Rib Cage Compression, Physical Therapy, Mechanical Ventilation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Rib Cage CompressionOther
Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
Compression + Ventilator HyperinflationOther
Mechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Rib Cage Compression | Active comparator | Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained. Receives: Other: Expiratory Rib Cage Compression |
| Compression + Ventilator Hyperinflation | Active comparator | Expiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. Receives: Other: Compression + Ventilator Hyperinflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static compliance of respiratory system
Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
Measured: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Total Resistance of respiratory system
The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
Measured: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Airway Resistance
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Measured: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Peak expiratory flow
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
Measured: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
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 start28 Nov 2014
- Primary completion5 Dec 2014
- Study completion11 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary AtelectasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- NCT03630484
- Sponsor's protocol ID
- VHI + Rib Cage Compression
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 Ventilator Hyperinflation and Manual Rib Cage Compression: Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03630484
- Acronym / sponsor ID
- VHI + Rib Cage Compression
- Conditions
- Pulmonary Atelectasis
- Keywords
- Ventilator Hyperinflation, Expiratory Rib Cage Compression, 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
- 28 Nov 2014 (actual)
- Primary completion
- 5 Dec 2014 (actual)
- Study completion
- 11 Jul 2017 (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.
This is a randomized crossover trial to evaluate the effects of thoracic compression applied alone or in association with hyperinflation maneuver with the ventilator. In addition, the mobilized volume and peak expiratory flow resulting from both maneuvers will be evaluated.
Detailed description
Ventilator hyperinflation is widely used in hypersecretive patients. It consists of increasing alveolar ventilation by facilitating the coughing mechanism so that the secretions of the peripheral airways are mobilized into the central airways so that they can be removed by tracheal aspiration or cough. Thoracic compression consists of manually compressing the rib cage during expiration, in order to increase expiratory flow, mobilize and remove pulmonary secretions. A randomized crossover clinical trial was performed with 30 patients submitted to isolated compression or associated with ventilator hyperinflation, with a 6 hour interval. Patients were evaluated through compliance and resistance of the respiratory system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expiratory Rib Cage Compression | Active comparator | Other: Expiratory Rib Cage CompressionExpiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained. |
| Compression + Ventilator Hyperinflation | Active comparator | Other: Compression + Ventilator HyperinflationExpiratory rib cage compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients under mechanical ventilation
- diagnosis of pulmonary infection
- hypersecretive
Key exclusion criteria (4 listed)
- haemodynamic instability (heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
- acute bronchospasm
- acute respiratory distress syndrome
- untreated pneumothorax
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 |
|---|---|---|
| Expiratory Rib Cage CompressionCompression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained. | Other | Expiratory Rib Cage Compression |
| Compression + Ventilator HyperinflationMechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling. | Other | Compression + Ventilator Hyperinflation |
Primary outcome
Static compliance of respiratory system
Time frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.
Total Resistance of respiratory system
Time frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.
Airway Resistance
Time frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.
Peak expiratory flow
Time frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration
The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.
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
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Rib Cage Compression and Compression + Ventilator Hyperinflation in people with Pulmonary Atelectasis, run by Brazilian Institute of Higher Education of Censa.
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 4 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.
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?
Static compliance of respiratory system (time frame: Baseline (before), immediately after ventilator hyperinflation or rib cage compression and five minutes after aspiration). The study lists 4 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.