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Completed

NCT Number: NCT01784146

Plethysmography Opto-electronic and Asthma

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratório de Fisiologia e Fisioterapia cardiorespiratória

Recife, Pernambuco, 50670901, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxygen

Other

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.

Heliox

Other

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.

PEEP

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Analysis of the Distribution of Pulmonary Ventilation After Nebulization by Heliox Associated With Positive Expiratory Pressure in Patients Asthmatics Stable.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 5, 2013
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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