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CompletedNCT03027180Updated Jan 23, 2017

Pressure Levels on Lung Expansion

An interventional study of Noninvasive positive airway pressure with different levels in Pleural Effusion, sponsored by Universidade Cidade de Sao Paulo. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-23.

Sponsored by Universidade Cidade de Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Pleural Effusion

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03

In context

Pleural Effusion

324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.

This study's enrollment of 4 is below the median of 63 across 212 interventional studies indexed under Pleural Effusion.

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Lead sponsor

Universidade Cidade de Sao Paulo is the lead sponsor of 40 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
4 participants (actual)

Study arms

  • Active comparator
    0 (zero) 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 0 cmH2O

    Device: Noninvasive positive airway pressure with different levels

  • Experimental
    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 4 cmH2O

    Device: Noninvasive positive airway pressure with different levels

  • Experimental
    15 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

    Device: Noninvasive positive airway pressure with different levels

Interventions

  • DeviceNoninvasive positive airway pressure with different levels
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What researchers measure

Primary outcomes

  1. Lung area

    Time frame: 20 seconds after pressure application

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03027180
Lead sponsor
Universidade Cidade de Sao Paulo
Responsible party
Adriana Claudia Lunardi (Professor, Universidade Cidade de Sao Paulo) — Principal investigator
First posted
Jan 23, 2017
Start date
Nov 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Jan 23, 2017

Study contacts

Adriana C Lunardi, PhD
principal investigator · Universidade Cidade de São Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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