Pressure Levels on Lung Expansion

NCT ID: NCT03027180

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Noninvasive positive airway pressure with different levels

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Noninvasive positive airway pressure with different levels

Intervention Type DEVICE

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

Group Type EXPERIMENTAL

Noninvasive positive airway pressure with different levels

Intervention Type DEVICE

Interventions

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Noninvasive positive airway pressure with different levels

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Cidade de Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Adriana Claudia Lunardi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana C Lunardi, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Cidade de São Paulo

Other Identifiers

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UNICID/CNPq 442709/2014-5

Identifier Type: -

Identifier Source: org_study_id

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