Expiratory Rib Cage Compression in Mechanically Ventilated Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernando Silva Guimaraes, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier:
NCT01525121
First received: January 28, 2012
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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 Intervention
Pulmonary Infection
Other: Expiratory Rib Cage Compression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Expiratory Rib Cage Compression Does Not Improve Secretion Clearance and Respiratory Mechanics in Mechanically Ventilated Patients

Further study details as provided by Centro Universitário Augusto Motta:

Primary Outcome Measures:
  • Sputum Volume (mL) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Fernando Silva Guimaraes, Associate Professor, Centro Universitário Augusto Motta
ClinicalTrials.gov Identifier: NCT01525121     History of Changes
Other Study ID Numbers: MTC_MV
Study First Received: January 28, 2012
Last Updated: February 1, 2012
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on April 17, 2014