Expiratory Rib Cage Compression in Mechanically Ventilated Patients
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 28, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedFebruary 2, 2012
February 1, 2012
11 months
January 28, 2012
February 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sputum Volume (mL)
Day 1
Secondary Outcomes (1)
Respiratory Mechanics
Day 1
Study Arms (2)
Expiratory Rib Cage Compression
EXPERIMENTALThis 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 INTERVENTIONThis 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients under mechanical ventilation
- diagnosis of pulmonary infection
- hypersecretive (defined as the interval between tracheal suctioning \< 2 hours)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Universitário Augusto Motta
Rio de Janeiro, Rio de Janeiro, 21041-010, Brazil
Related Publications (1)
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.
PMID: 24106324DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fernando S Guimarães, PhD
Centro Universitário Augusto Motta
- PRINCIPAL INVESTIGATOR
Sara LS Menezes, PhD
Centro Universitário Augusto Motta
- PRINCIPAL INVESTIGATOR
Agnaldo J Lopes, PhD
Centro Universitário Augusto Motta
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 28, 2012
First Posted
February 2, 2012
Study Start
July 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
February 2, 2012
Record last verified: 2012-02