Expiratory Rib Cage Compression in Mechanically Ventilated Patients
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| First Received Date ICMJE | January 28, 2012 | ||||||||||||
| Last Updated Date | February 1, 2012 | ||||||||||||
| Start Date ICMJE | July 2008 | ||||||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Sputum Volume (mL) [ Time Frame: Day 1 ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01525121 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Respiratory Mechanics [ Time Frame: Day 1 ] [ Designated as safety issue: No ] Static and effective compliance of the respiratory system Total resistance of the respiratory system |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Expiratory Rib Cage Compression in Mechanically Ventilated Patients | ||||||||||||
| Official Title ICMJE | Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients | ||||||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Pulmonary Infection | ||||||||||||
| Intervention ICMJE | Other: Expiratory Rib Cage 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.
Other Name: Manual thoracic compression |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 20 | ||||||||||||
| Completion Date | June 2009 | ||||||||||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 19 Years to 90 Years | ||||||||||||
| 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 | NCT01525121 | ||||||||||||
| Other Study ID Numbers ICMJE | MTC_MV | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | Fernando Silva Guimaraes, Centro Universitário Augusto Motta | ||||||||||||
| Study Sponsor ICMJE | Centro Universitário Augusto Motta | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Centro Universitário Augusto Motta | ||||||||||||
| Verification Date | February 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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