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Plethysmography Opto-electronic and Asthma

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ClinicalTrials.gov Identifier: NCT01784146
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):
Daniella Cunha Brandao, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Asthma Other: Oxygen Other: Heliox Other: PEEP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Analysis of the Distribution of Pulmonary Ventilation After Nebulization by Heliox Associated With Positive Expiratory Pressure in Patients Asthmatics Stable.
Study Start Date : June 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Heliox

Arm Intervention/treatment
Placebo Comparator: Oxygen Other: Oxygen

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.


Experimental: PEEP + Heliox Other: Heliox

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.


Other: PEEP
PEEP supplied was 10 cm H2O through valve (Vital Signs,Totowa, USA) attached to the expiratory branch.

Experimental: Oxygen + PEEP Other: Oxygen

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.


Other: PEEP
PEEP supplied was 10 cm H2O through valve (Vital Signs,Totowa, USA) attached to the expiratory branch.

Active Comparator: Heliox Other: Heliox

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.





Primary Outcome Measures :
  1. Distribution of volumes of the rib cage in asthma patients-Plesthysmography opto - electronic (POE). [ Time Frame: 5 months ]
    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 :
  1. Lung function in asthmatic subjects [ Time Frame: 5 mothns ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784146


Locations
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Brazil
Laboratório de Fisiologia e Fisioterapia cardiorespiratória
Recife, Pernambuco, Brazil, 50670901
Sponsors and Collaborators
Universidade Federal de Pernambuco

Publications of Results:
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Responsible Party: Daniella Cunha Brandao, PhD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT01784146    
Other Study ID Numbers: Luciana 2
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: December 2012
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases