Pulmonary InfectionNCT01525121
Expiratory Rib Cage Compression in Mechanically Ventilated Patients
A study testing Expiratory Rib Cage Compression in people with Pulmonary Infection, run by Centro Universitário Augusto Motta at 1 site in Brazil.
Trial summary
This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage compression technique improves respiratory mechanics and is effective in secretion removal in mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Pulmonary Infection
- What is being tested?
- Expiratory Rib Cage Compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2008to Jun 2009
- 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 19 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 (defined as the interval between tracheal suctioning < 2 hours)
Who cannot join
- haemodynamic instability (defined by heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
- use of vasopressor drugs
- absence of respiratory drive
- acute bronchospasm
- acute respiratory distress syndrome
- atelectasis (identified by an independent radiologist that was not participating in the study)
- untreated pneumothorax
- lung haemorrhage.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Universitário Augusto Motta
Rio de Janeiro, Rio de Janeiro, 21041-010
About this study
Official title: Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients
This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage compression technique improves respiratory mechanics and is effective in secretion removal in mechanically ventilated patients.
Read the detailed description
Chest physiotherapy is an essential component of the multidisciplinary approach in critical care settings. In this context, a number of devices and manual techniques have been used to remove pulmonary secretions and re-expand collapsed areas. This study was designed to evaluate whether manual rib cage compression improves airway clearance and respiratory mechanics in mechanically ventilated patients. In a randomized crossover trial, 20 mechanically ventilated patients underwent thoracic manual compression and control intervention (normal ventilation) at the same day. The main outcomes were sputum production and the changes in respiratory mechanics.
- Conditions
- Pulmonary Infection
- Being tested
- Expiratory Rib Cage Compression
- Keywords
- mechanical ventilation, chest physiotherapy, critical care, pneumonia, Mechanically ventilated patients with pulmonary infection.
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expiratory Rib Cage CompressionOther
Also called Manual thoracic compression
The therapist hands were positioned on the lower ribs, and the force was applied every two breaths only during the expiration, synchronizing the maneuver rate with the patient's respiratory rate. Then, the patients underwent a suctioning procedure, and a hyperinflation maneuver consisting of a 10 minutes period under pressure support ventilation of 35 cmH2O was done. In control intervention instead of the compressive maneuver the patients were kept on normal ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Expiratory Rib Cage Compression | Experimental | This a crossover study, so all subjects performed both, control and experimental interventions. The patients were kept in supine at 30 degree head-up position. Ventilatory mode was changed to volume-controlled, with a tidal volume of 8mL/kg, inspiratory flow of 60 Lpm and positive end expiratory pressure (PEEP) of 5 cmH2O. A first tracheal suctioning was done, and the mucus was discarded. Then, a series of two minutes of bilateral expiratory rib-cage compressions ensued. Aiming to minimize inter-therapist variability, the maneuver was applied by the same registered and trained physiotherapist. Control intervention followed the same sequence, but instead of the compressive maneuver they were kept on normal ventilation with the parameters described above. Receives: Other: Expiratory Rib Cage Compression |
| Control | No intervention | This a crossover study, so all subjects performed both, control and experimental interventions. The patients were kept in supine at 30 degree head-up position. Ventilatory mode was changed to volume-controlled, with a tidal volume of 8mL/kg, inspiratory flow of 60 Lpm and positive end expiratory pressure (PEEP) of 5 cmH2O. A first tracheal suctioning was done, and the mucus was discarded. Then, a series of two minutes of bilateral expiratory rib-cage compressions ensued. Aiming to minimize inter-therapist variability, the maneuver was applied by the same registered and trained physiotherapist. Control intervention followed the same sequence, but instead of the compressive maneuver they were kept on normal ventilation with the parameters described above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum Volume (mL)
Measured: Day 1
Secondary outcomes (1)
Respiratory Mechanics
Static and effective compliance of the respiratory system Total resistance of the respiratory system
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJul 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary InfectionStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitário Augusto Motta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Silva Guimaraes, Centro Universitário Augusto Motta
- Investigators
- Fernando S Guimarães, PhD, Study chair, Centro Universitário Augusto MottaSara LS Menezes, PhD, Principal investigator, Centro Universitário Augusto MottaAgnaldo J Lopes, PhD, Principal investigator, Centro Universitário Augusto Motta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525121
- Sponsor's protocol ID
- MTC_MV
- Status last verified
- Feb 2012
- First submitted
- 28 Jan 2012
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Guimaraes FS, Lopes AJ, Constantino SS, Lima JC, Canuto P, de Menezes SL. Expiratory rib cage Compression in mechanically ventilated subjects: a randomized crossover trial [corrected]. Respir Care. 2014 May;59(5):678-85. doi: 10.4187/respcare.02587. Epub 2013 Oct 8.
PubMed 24106324
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT01525121
- Acronym / sponsor ID
- MTC_MV
- Conditions
- Pulmonary Infection
- Keywords
- mechanical ventilation, chest physiotherapy, critical care, pneumonia, Mechanically ventilated patients with pulmonary infection.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centro Universitário Augusto MottaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 2 Feb 2012 (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.
This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage compression technique improves respiratory mechanics and is effective in secretion removal in mechanically ventilated patients.
Detailed description
Chest physiotherapy is an essential component of the multidisciplinary approach in critical care settings. In this context, a number of devices and manual techniques have been used to remove pulmonary secretions and re-expand collapsed areas. This study was designed to evaluate whether manual rib cage compression improves airway clearance and respiratory mechanics in mechanically ventilated patients. In a randomized crossover trial, 20 mechanically ventilated patients underwent thoracic manual compression and control intervention (normal ventilation) at the same day. The main outcomes were sputum production and the changes in respiratory mechanics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expiratory Rib Cage Compression | Experimental | Other: Expiratory Rib Cage CompressionThis a crossover study, so all subjects performed both, control and experimental interventions. The patients were kept in supine at 30 degree head-up position. Ventilatory mode was changed to volume-controlled, with a tidal volume of 8mL/kg, inspiratory flow of 60 Lpm and positive end expiratory pressure (PEEP) of 5 cmH2O. A first tracheal suctioning was done, and the mucus was discarded. Then, a series of two minutes of bilateral expiratory rib-cage compressions ensued. Aiming to minimize inter-therapist variability, the maneuver was applied by the same registered and trained physiotherapist. Control intervention followed the same sequence, but instead of the compressive maneuver they were kept on normal ventilation with the parameters described above. |
| Control | No intervention | –This a crossover study, so all subjects performed both, control and experimental interventions. The patients were kept in supine at 30 degree head-up position. Ventilatory mode was changed to volume-controlled, with a tidal volume of 8mL/kg, inspiratory flow of 60 Lpm and positive end expiratory pressure (PEEP) of 5 cmH2O. A first tracheal suctioning was done, and the mucus was discarded. Then, a series of two minutes of bilateral expiratory rib-cage compressions ensued. Aiming to minimize inter-therapist variability, the maneuver was applied by the same registered and trained physiotherapist. Control intervention followed the same sequence, but instead of the compressive maneuver they were kept on normal ventilation with the parameters described above. |
Who may qualify
- Ages
- 19 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 (defined as the interval between tracheal suctioning < 2 hours)
Key exclusion criteria (8 listed)
- haemodynamic instability (defined by heart rate > 130 bpm and mean arterial pressure < 60 mmHg)
- use of vasopressor drugs
- absence of respiratory drive
- acute bronchospasm
- acute respiratory distress syndrome
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 CompressionAlso: Manual thoracic compressionThe therapist hands were positioned on the lower ribs, and the force was applied every two breaths only during the expiration, synchronizing the maneuver rate with the patient's respiratory rate. Then, the patients underwent a suctioning procedure, and a hyperinflation maneuver consisting of a 10 minutes period under pressure support ventilation of 35 cmH2O was done. In control intervention instead of the compressive maneuver the patients were kept on normal ventilation. | Other | Expiratory Rib Cage Compression |
Primary outcome
Sputum Volume (mL)
Time frame: Day 1
1 secondary outcome
Respiratory Mechanics
Time frame: Day 1
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 2 Feb 2012.
- Derived from this study: PubMed 24106324Guimaraes FS, Lopes AJ, Constantino SS, Lima JC, Canuto P, de Menezes SL. Expiratory rib cage Compression in mechanically ventilated subjects: a randomized crossover trial [corrected]. Respir Care. 2014 May;59(5):678-85. doi: 10.4187/respcare.02587. Epub 2013 Oct 8.
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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.
Fernando S Guimarães, PhD study chair
Centro Universitário Augusto Motta
Sara LS Menezes, PhD principal investigator
Centro Universitário Augusto Motta
Agnaldo J Lopes, PhD principal investigator
Centro Universitário Augusto Motta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expiratory Rib Cage Compression in people with Pulmonary Infection, run by Centro Universitário Augusto Motta 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 8 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 2 Feb 2012. 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?
Sputum Volume (mL) (time frame: Day 1). 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 NCT01525121, which also lists 1 linked publication.
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 2 Feb 2012.