Expiratory Rib Cage Compression in Mechanically Ventilated Patients - Full Text View

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.

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 May 21, 2013