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Positive Airway Pressure on Pleural Effusion After Drainage

Primary Purpose

Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Positive Airway Pressure
Conventional Chest Physiotherapy
Control group
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring pleural effusion, chest tube, respiratory therapy, intermittent positive-pressure breathing, lung function, pulmonary complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital das Clínicas Dr. Alberto Lima

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Positive Airway Pressure group

Conventional Chest Physiotherapy group

Control group

Arm Description

The patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and walking for 100 meters (i.e., the same treatment that will be administered to the Conventional Chest Physiotherapy group). Additionally, this group will receive positive airway pressure breathing with 15 mmHg by a device via a rubber facial mask for 30 minutes in a sitting position.

In the sitting position, the patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and positive airway pressure breathing with 4 mmHg via a rubber facial mask for 5 minutes in a sitting position. These patients will also walk for 100 meters. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the equipment in the room and mark the patient's skin.

The patients allocated to this group will receive positive airway pressure breathing with 4 mmHg (without therapeutic value) via a rubber facial mask for 30 minutes in a sitting position. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the complete kit of equipment in the room.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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%)
Length of hospital stay
The number of days in the hospital after chest drainage until discharge will be counted for each patient

Full Information

First Posted
September 16, 2014
Last Updated
January 17, 2017
Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02246946
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
pleural effusion, chest tube, respiratory therapy, intermittent positive-pressure breathing, lung function, pulmonary complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Airway Pressure group
Arm Type
Experimental
Arm Description
The patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and walking for 100 meters (i.e., the same treatment that will be administered to the Conventional Chest Physiotherapy group). Additionally, this group will receive positive airway pressure breathing with 15 mmHg by a device via a rubber facial mask for 30 minutes in a sitting position.
Arm Title
Conventional Chest Physiotherapy group
Arm Type
Active Comparator
Arm Description
In the sitting position, the patients allocated to this group will undergo bronchial hygiene treatments administered with a high-frequency oscillator for 5 sets of 10 repetitions, lung expansion exercises using flow oriented incentive spirometry for 5 sets of 20 repetitions and positive airway pressure breathing with 4 mmHg via a rubber facial mask for 5 minutes in a sitting position. These patients will also walk for 100 meters. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the equipment in the room and mark the patient's skin.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patients allocated to this group will receive positive airway pressure breathing with 4 mmHg (without therapeutic value) via a rubber facial mask for 30 minutes in a sitting position. The use of positive pressure breathing with 4 mmHg has no therapeutic value, but will help keep the blinding of assessors by the presence of the complete kit of equipment in the room.
Intervention Type
Device
Intervention Name(s)
Positive Airway Pressure
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional Chest Physiotherapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide
Primary Outcome Measure Information:
Title
Duration of chest tube drainage
Description
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
Time Frame
All patients will be followed for the duration of hospital stay, an expected average of 7 days of chest drainage
Secondary Outcome Measure Information:
Title
Spirometry
Description
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
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
Title
Peripheral Oxygen Saturation
Description
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.
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
Title
Pulmonary complications
Description
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%)
Time Frame
All patients will be followed for the duration of hospital stay, an expected average of 10 days
Title
Length of hospital stay
Description
The number of days in the hospital after chest drainage until discharge will be counted for each patient
Time Frame
All patients will be followed for the duration of hospital stay, an expected average of 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana C Lunardi, PhD
Organizational Affiliation
Universidade Cidade de Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elinaldo C Santos, MSc
Organizational Affiliation
Hospital das Clínicas Dr. Alberto Lima
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas Dr. Alberto Lima
City
Macapá
State/Province
Amapá
ZIP/Postal Code
68900073
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31843426
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.
Results Reference
derived
PubMed Identifier
25744852
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.
Results Reference
derived

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Positive Airway Pressure on Pleural Effusion After Drainage

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