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Expiratory Rib Cage Compression in Mechanically Ventilated Patients

Primary Purpose

Pulmonary Infection

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Expiratory Rib Cage Compression
Sponsored by
Centro Universitário Augusto Motta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Infection focused on measuring mechanical ventilation, chest physiotherapy, critical care, pneumonia, Mechanically ventilated patients with pulmonary infection.

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Universitário Augusto Motta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Expiratory Rib Cage Compression

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Sputum Volume (mL)

Secondary Outcome Measures

Respiratory Mechanics
Static and effective compliance of the respiratory system Total resistance of the respiratory system

Full Information

First Posted
January 28, 2012
Last Updated
February 1, 2012
Sponsor
Centro Universitário Augusto Motta
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1. Study Identification

Unique Protocol Identification Number
NCT01525121
Brief Title
Expiratory Rib Cage Compression in Mechanically Ventilated Patients
Official Title
Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário Augusto Motta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Infection
Keywords
mechanical ventilation, chest physiotherapy, critical care, pneumonia, Mechanically ventilated patients with pulmonary infection.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expiratory Rib Cage Compression
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Expiratory Rib Cage Compression
Other Intervention Name(s)
Manual thoracic compression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sputum Volume (mL)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Respiratory Mechanics
Description
Static and effective compliance of the respiratory system Total resistance of the respiratory system
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando S Guimarães, PhD
Organizational Affiliation
Centro Universitário Augusto Motta
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sara LS Menezes, PhD
Organizational Affiliation
Centro Universitário Augusto Motta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Agnaldo J Lopes, PhD
Organizational Affiliation
Centro Universitário Augusto Motta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Universitário Augusto Motta
City
Rio de Janeiro
ZIP/Postal Code
21041-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24106324
Citation
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. Erratum In: Respir Care. 2014 Jul;59(7):e107.
Results Reference
derived

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Expiratory Rib Cage Compression in Mechanically Ventilated Patients

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