Pressure Levels on Lung Expansion

January 20, 2017 updated by: Adriana Claudia Lunardi, Universidade Cidade de Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lung area
Time Frame: 20 seconds after pressure application
20 seconds after pressure application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Cidade de Sao Paulo

Investigators

  • Principal Investigator: Adriana C Lunardi, PhD, Universidade Cidade de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (ESTIMATE)

January 23, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNICID/CNPq 442709/2014-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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