Pressure Levels on Lung Expansion

Pleural Effusion Clinical Trial

Official title:

DIFFERENT LEVELS OF NONINVASIVE POSITIVE AIRWAY PRESSURE FOR LUNG EXPANSION ON PATIENTS WITH PLEURAL DRAINAGE: A STUDY VIA COMPUTED TOMOGRAPHY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03027180
• Other study ID #: UNICID/CNPq 442709/2014-5
• Status: Completed
• Phase: N/A
• First received: January 17, 2017
• Last updated: January 20, 2017
• Start date: November 2016
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Device:
• Noninvasive positive airway pressure with different levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung area		20 seconds after pressure application