search
Back to results

Plethysmography Opto-electronic and Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Oxygen
Heliox
PEEP
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study included individuals diagnosed with moderate to severe asthma with forced expiratory volume in one second (FEV1) <60% or FEV1 <60% - 80% predicted;
  • showing reversibility of bronchial obstruction after administration of bronchodilators at least 10% in FEV1.

Exclusion Criteria:

  • unable to understand or perform the spirometric maneuver;
  • with a history of smoking;
  • pulmonary comorbidities as chronic obstructive pulmonary disease (COPD);
  • bronchiectasis and tuberculosis sequel;
  • hemodynamic instability defined as heart rate (HR) greater than 150 bpm or systolic blood pressure below 90 mmHg or greater than 150mmHg;
  • pregnancy and any contraindication to the use of PEEP;
  • such as increased work of breathing (acute asthma);
  • active hemoptysis;
  • acute sinusitis;
  • pneumothorax;
  • untreated; surgery or facial trauma;
  • oral or injury;
  • epistaxis;
  • nausea and esophageal surgery.

Sites / Locations

  • Laboratório de Fisiologia e Fisioterapia cardiorespiratória

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Arm Label

Oxygen

PEEP + Heliox

Oxygen + PEEP

Heliox

Arm Description

Outcomes

Primary Outcome Measures

Distribution of volumes of the rib cage in asthma patients-Plesthysmography opto - electronic (POE).
The markers are meant to reflect the infrared signal emitted by the POE to the sensors, which transform these signals into information about the movement of the chest. In this evaluation method the chest is considered a geometric model divided into three regions - the volume of pulmonary rib cage (Vrp), abdominal rib cage volume (Vra), part of the chest corresponding to the diaphragm, and abdomen (Va), and the overall volume of the chest (Vcw) the total volume of compartments.

Secondary Outcome Measures

Lung function in asthmatic subjects
In spirometry values were obtained for FEV1, PEF and forced vital capacity (FVC), considering the record as the best value according to the American Thoracic Society 18 the percentage of the predicted 16. For IC, we performed a correction of the weight. The present study included all patients were instructed to discontinue their medication twelve hours before the experiment as corticosteroids and bronchodilators for short or long duration for performing spirometry

Full Information

First Posted
January 30, 2013
Last Updated
February 1, 2013
Sponsor
Universidade Federal de Pernambuco
search

1. Study Identification

Unique Protocol Identification Number
NCT01784146
Brief Title
Plethysmography Opto-electronic and Asthma
Official Title
Analysis of the Distribution of Pulmonary Ventilation After Nebulization by Heliox Associated With Positive Expiratory Pressure in Patients Asthmatics Stable.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To assess the influence of nebulization with bronchodilators carried by the heliox coupled to PEP in the distribution of compartimental lung volumes in asmathic adults and to correlate with pulmonary function data. Methods: A controlled randomized trial involving 27 patients divided into four groups: heliox + PEP, oxygen + PEP, heliox and oxygen. After the initial evaluation, it was placing 89 reflective markers attached to the surface of the trunk and images acquired by optoelectronic plethysmography (OEP) of six cameras. Three slow vital capacity maneuvers and quiet breathing regarded as phase control. After the control phase, all patients underwent nebulization with a distribution noninvasive system, semi-closed using 10 drops of Fenoterol Bromide and 20 drops of Ipratropium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygen
Arm Type
Placebo Comparator
Arm Title
PEEP + Heliox
Arm Type
Experimental
Arm Title
Oxygen + PEEP
Arm Type
Experimental
Arm Title
Heliox
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
For inhalation of oxygen, we used a noninvasive delivery system, semi - closed (Figure 3) consisting of a non-toxic face mask with two unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer (Airlife Misty Neb, Baxter; Valencia, CA, USA). In the inspiratory branch, a reservoir bag (Hudson RCI, USA) with capacity of 2.5 L was connected, in order to avoid dilution of the gas. This skin was fixed to the patient's face to prevent leakage and to maintain adequate pressurization and improved patient compliance to the PEEP. The nebulizer was fed by a flow of 8 l / min of oxygen.
Intervention Type
Other
Intervention Name(s)
Heliox
Intervention Description
For inhalation of heliox, we used a noninvasive delivery system, semi - closed consisting of a non-toxic face mask with two unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer (Airlife Misty Neb, Baxter; Valencia, CA, USA). In the inspiratory branch, a reservoir bag (Hudson RCI, USA) with capacity of 2.5 L was connected, in order to avoid dilution of the gas. This skin was fixed to the patient's face to prevent leakage and to maintain adequate pressurization and improved patient compliance to the PEEP. The nebulizer was fed by a 11 l / min of heliox for the heliox group in accordance with a protocol of Hess et al.
Intervention Type
Other
Intervention Name(s)
PEEP
Intervention Description
PEEP supplied was 10 cm H2O through valve (Vital Signs,Totowa, USA) attached to the expiratory branch.
Primary Outcome Measure Information:
Title
Distribution of volumes of the rib cage in asthma patients-Plesthysmography opto - electronic (POE).
Description
The markers are meant to reflect the infrared signal emitted by the POE to the sensors, which transform these signals into information about the movement of the chest. In this evaluation method the chest is considered a geometric model divided into three regions - the volume of pulmonary rib cage (Vrp), abdominal rib cage volume (Vra), part of the chest corresponding to the diaphragm, and abdomen (Va), and the overall volume of the chest (Vcw) the total volume of compartments.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Lung function in asthmatic subjects
Description
In spirometry values were obtained for FEV1, PEF and forced vital capacity (FVC), considering the record as the best value according to the American Thoracic Society 18 the percentage of the predicted 16. For IC, we performed a correction of the weight. The present study included all patients were instructed to discontinue their medication twelve hours before the experiment as corticosteroids and bronchodilators for short or long duration for performing spirometry
Time Frame
5 mothns

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study included individuals diagnosed with moderate to severe asthma with forced expiratory volume in one second (FEV1) <60% or FEV1 <60% - 80% predicted; showing reversibility of bronchial obstruction after administration of bronchodilators at least 10% in FEV1. Exclusion Criteria: unable to understand or perform the spirometric maneuver; with a history of smoking; pulmonary comorbidities as chronic obstructive pulmonary disease (COPD); bronchiectasis and tuberculosis sequel; hemodynamic instability defined as heart rate (HR) greater than 150 bpm or systolic blood pressure below 90 mmHg or greater than 150mmHg; pregnancy and any contraindication to the use of PEEP; such as increased work of breathing (acute asthma); active hemoptysis; acute sinusitis; pneumothorax; untreated; surgery or facial trauma; oral or injury; epistaxis; nausea and esophageal surgery.
Facility Information:
Facility Name
Laboratório de Fisiologia e Fisioterapia cardiorespiratória
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670901
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
1864100
Citation
Frischknecht-Christensen E, Norregaard O, Dahl R. Treatment of bronchial asthma with terbutaline inhaled by conespacer combined with positive expiratory pressure mask. Chest. 1991 Aug;100(2):317-21. doi: 10.1378/chest.100.2.317.
Results Reference
result
PubMed Identifier
7842183
Citation
Manthous CA, Hall JB, Caputo MA, Walter J, Klocksieben JM, Schmidt GA, Wood LD. Heliox improves pulsus paradoxus and peak expiratory flow in nonintubated patients with severe asthma. Am J Respir Crit Care Med. 1995 Feb;151(2 Pt 1):310-4. doi: 10.1164/ajrccm.151.2.7842183.
Results Reference
result

Learn more about this trial

Plethysmography Opto-electronic and Asthma

We'll reach out to this number within 24 hrs