Clinical trial NCT01784146: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-02-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Distribution of volumes of the rib cage in asthma patients-Plesthysmography opto - electronic (POE).
timeFrame: 5 months
Secondary outcomes:
measure: Lung function in asthmatic subjects
timeFrame: 5 mothns
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Laboratório de Fisiologia e Fisioterapia cardiorespiratória
state: Pernambuco
Study officials:
References:
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.
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.