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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01525121
Other study ID # MTC_MV
Secondary ID
Status Completed
Phase N/A
First received January 28, 2012
Last updated February 1, 2012
Start date July 2008
Est. completion date June 2009

Study information

Verified date February 2012
Source Centro Universitário Augusto Motta
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 90 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Centro Universitário Augusto Motta Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Centro Universitário Augusto Motta

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sputum Volume (mL) Day 1 No
Secondary Respiratory Mechanics Static and effective compliance of the respiratory system Total resistance of the respiratory system Day 1 No
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