Back to resultsPressure Levels on Lung Expansion
Primary Purpose
Pleural Effusion
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Noninvasive positive airway pressure with different levels
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion
Eligibility Criteria
Inclusion Criteria:
- age over 18 years
- presence of pleural drainage after traumatic hemothorax
- thoracic drainage within 24 hours
- controlled pain (below 3 points in the visual numeric scale, varying from zero to ten)
Exclusion Criteria:
- contraindication for use of noninvasive positive pressure in the airways, such as reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea, vomiting, upper gastrointestinal bleeding
- previous application of any sort of lung expansion technique after thoracic drainage.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
0 (zero) cmH2O
4 cmH2O
15 cmH2O
Arm Description
After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 0 cmH2O
After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 4 cmH2O
After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 15 cmH2O
Outcomes
Primary Outcome Measures
Lung area
Secondary Outcome Measures
Full Information
NCT ID
NCT03027180
First Posted
January 17, 2017
Last Updated
January 20, 2017
Sponsor
Universidade Cidade de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03027180
Brief Title
Pressure Levels on Lung Expansion
Official Title
DIFFERENT LEVELS OF NONINVASIVE POSITIVE AIRWAY PRESSURE FOR LUNG EXPANSION ON PATIENTS WITH PLEURAL DRAINAGE: A STUDY VIA COMPUTED TOMOGRAPHY
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2016 (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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Question: What level of noninvasive positive airway pressure is able to expand the lungs of people with pleural drainage? Design: Cross-sectional, experimental and randomized study. Participants: Four consecutive people with pleural effusion drained within 24 hours, with controlled pain and without contraindications to use of noninvasive positive pressure. Intervention: Each person will be randomly subjected to three levels of noninvasive positive airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography. Outcome measures: Lung area.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0 (zero) cmH2O
Arm Type
Active Comparator
Arm Description
After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 0 cmH2O
Arm Title
4 cmH2O
Arm Type
Experimental
Arm Description
After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 4 cmH2O
Arm Title
15 cmH2O
Arm Type
Experimental
Arm Description
After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 15 cmH2O
Intervention Type
Device
Intervention Name(s)
Noninvasive positive airway pressure with different levels
Primary Outcome Measure Information:
Title
Lung area
Time Frame
20 seconds after pressure application
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 drainage after traumatic hemothorax
thoracic drainage within 24 hours
controlled pain (below 3 points in the visual numeric scale, varying from zero to ten)
Exclusion Criteria:
contraindication for use of noninvasive positive pressure in the airways, such as reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea, vomiting, upper gastrointestinal bleeding
previous application of any sort of lung expansion technique after thoracic drainage.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana C Lunardi, PhD
Organizational Affiliation
Universidade Cidade de São Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Pressure Levels on Lung Expansion
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