Clinical trial NCT02246946: Positive Airway Pressure on Pleural Effusion After Drainage
Official title: Efficacy of the Addition of Positive Airway Pressure to Conventional Chest Physiotherapy in the Time to Resolution of Pleural Effusion After Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: pleural effusion
chest tube
respiratory therapy
intermittent positive-pressure breathing
lung function
pulmonary complications
Lead sponsor: Universidade Cidade de Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-09-23
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Duration of chest tube drainage
timeFrame: All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage
Secondary outcomes:
measure: Spirometry
timeFrame: 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
measure: Peripheral Oxygen Saturation
timeFrame: 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
measure: Pulmonary complications
timeFrame: All patients will be followed for the duration of hospital stay, an expected average of 10 days
measure: Length of hospital stay
timeFrame: All patients will be followed for the duration of hospital stay, an expected average of 10 days
Other outcomes:
Locations:
city: Macapá
country: Brazil
facility: Hospital das Clínicas Dr. Alberto Lima
state: Amapá
Study officials:
affiliation: Universidade Cidade de Sao Paulo
name: Adriana C Lunardi, PhD
role: STUDY_DIRECTOR
affiliation: Hospital das Clínicas Dr. Alberto Lima
name: Elinaldo C Santos, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dos Santos EDC, da Silva JS, de Assis Filho MTT, Vidal MB, Monte MC, Lunardi AC. Adding positive airway pressure to mobilisation and respiratory techniques hastens pleural drainage: a randomised trial. J Physiother. 2020 Jan;66(1):19-26. doi: 10.1016/j.jphys.2019.11.006. Epub 2019 Dec 13.
citation: da Conceicao Dos Santos E, Lunardi AC. Efficacy of the addition of positive airway pressure to conventional chest physiotherapy in resolution of pleural effusion after drainage: protocol for a randomised controlled trial. J Physiother. 2015 Apr;61(2):93. doi: 10.1016/j.jphys.2014.11.016. Epub 2015 Mar 3.