Positive Airway Pressure on Pleural Effusion After Drainage

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02246946
• Other study ID #: UNICID14
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: January 17, 2017
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age over 18 years

• presence of pleural effusion

• have undergone chest drain for fewer than 24 hours

Exclusion Criteria:

• contraindication to the use of non-invasive equipment that generates positive airway pressure (such as: intolerance, phobia, drowsiness, restlessness, confusion, hemodynamic instability requiring vasopressor therapy, systolic blood pressure < 90 mmHg, facial trauma, ineffective cough or inability to swallow, nausea or vomiting, upper gastrointestinal bleeding, acute myocardial infarction within the last 48 hours, pneumothorax or bullous emphysema)

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• Positive Airway Pressure
To this group, Intermittent Positive Airway Pressure Breathing with 15 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide

Other:
• Conventional Chest Physiotherapy
To this group, routine physiotherapy exercises will be conducted plus Intermittent Positive Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide

Procedure:
• Control group
to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas Dr. Alberto Lima	Macapá	Amapá

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of chest tube 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	All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage
Secondary	Spirometry	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	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
Secondary	Peripheral Oxygen Saturation	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.	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
Secondary	Pulmonary complications	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%)	All patients will be followed for the duration of hospital stay, an expected average of 10 days
Secondary	Length of hospital stay	The number of days in the hospital after chest drainage until discharge will be counted for each patient	All patients will be followed for the duration of hospital stay, an expected average of 10 days