- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525121
Expiratory Rib Cage Compression in Mechanically Ventilated Patients
February 1, 2012 updated by: Fernando Silva Guimaraes, Centro Universitário Augusto Motta
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rio de Janeiro, Brazil, 21041-010
- Centro Universitário Augusto Motta
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients under mechanical ventilation
- diagnosis of pulmonary infection
- hypersecretive (defined as the interval between tracheal suctioning < 2 hours)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Expiratory Rib Cage Compression
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.
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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 Names:
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No Intervention: Control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sputum Volume (mL)
Time Frame: Day 1
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Mechanics
Time Frame: Day 1
|
Static and effective compliance of the respiratory system Total resistance of the respiratory system
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Agnaldo J Lopes, PhD, Centro Universitário Augusto Motta
- Study Chair: FERNANDO S GUIMARAES, PhD, Centro Universitário Augusto Motta
- Principal Investigator: Sara LS Menezes, PhD, Centro Universitário Augusto Motta
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
January 28, 2012
First Submitted That Met QC Criteria
February 1, 2012
First Posted (Estimate)
February 2, 2012
Study Record Updates
Last Update Posted (Estimate)
February 2, 2012
Last Update Submitted That Met QC Criteria
February 1, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTC_MV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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