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Expiratory Rib Cage Compression in Mechanically Ventilated Patients

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ClinicalTrials.gov Identifier: NCT01525121
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Fernando Silva Guimaraes, Centro Universitário Augusto Motta

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Infection Other: Expiratory Rib Cage Compression Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients
Study Start Date : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009
Arms and Interventions
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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.
 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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Sputum Volume (mL) [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Respiratory Mechanics [ Time Frame: Day 1 ]
    Static and effective compliance of the respiratory system Total resistance of the respiratory system


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525121


Locations
Brazil
Centro Universitário Augusto Motta
Rio de Janeiro, Brazil, 21041-010
Sponsors and Collaborators
Centro Universitário Augusto Motta
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fernando Silva Guimaraes, Associate Professor, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01525121     History of Changes
Other Study ID Numbers: MTC_MV
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by Fernando Silva Guimaraes, Centro Universitário Augusto Motta:
mechanical ventilation
chest physiotherapy
critical care
pneumonia
Mechanically ventilated patients with pulmonary infection.