Clinical Trial: Positive Airway Pressure on Pleural Effusion After Drainage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of the Addition of Positive Airway Pressure to Conventional Chest Physiotherapy in the Time to Resolution of Pleural Effusion After Drainage

Brief Summary: The purpose of this study is to determine if the addition of intermittent positive airway pressure breathing (specific lung expansion technique) to conventional chest physiotherapy chest drainage is effective to accelerate the reabsorption of pleural effusion and consequently decrease the duration of chest tube drainage and respiratory system impairment. These effects would decrease hospital stay lengths and the incidence of pulmonary complications.

Detailed Summary:
Sponsor: Universidade Cidade de Sao Paulo

Current Primary Outcome: Duration of chest tube drainage [ Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage ]

The criteria for the removal the chest drain will an output of transudative fluid over 24h ≤ 200 ml and full lung expansion on chest radiography


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Spirometry [ Time Frame: On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol ]
    The blind assessor will use a portable spirometer according previously established implementation and acceptability criteria. The following variables will be considered: forced vital capacity, forced expiratory volume in the 1st second, and forced expiratory flow between 25% and 75% of the curve. The predictive values for the Brazilian population will be used
  • Peripheral Oxygen Saturation [ Time Frame: On the 4th and 8th days after the beginning of the intervention protocol. Or on the day of hospital discharge if it occurs prior to the 8th day of protocol ]
    The patients will be required to breath room air (without supplemental oxygen) for at least 10 minutes prior to the assessments. The blind assessor will use a portable pulse oximeter.
  • Pulmonary complications [ Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 10 days ]
    The occurrence of the following complications will be monitored until the day of hospital discharge by a physician blinded to the intervention groups: pneumonia (chest radiography with pulmonary infiltrate associated with two of the following signs: purulent expectoration, temperature above 38.3°C and a greater than 25% increase in baseline leukocyte count with hyperthermia); atelectasis (RX associated with abnormal chest acute respiratory symptoms); and hypoxemia (peripheral oxygen saturation associated with respiratory symptoms below 85%)
  • Length of hospital stay [ Time Frame: All patients will be followed for the duration of hospital stay, an expected average of 10 days ]
    The number of days in the hospital after chest drainage until discharge will be counted for each patient


Original Secondary Outcome: Same as current

Information By: Universidade Cidade de Sao Paulo

Dates:
Date Received: September 16, 2014
Date Started: December 2014
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017