Plethysmography Opto-electronic and Asthma

NCT01784146 | Completed DMC

• 1 other identifier: Luciana 2
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  5 months

Secondary Outcomes (1)

• Lung function in asthmatic subjects

  5 mothns

Study Arms (4)

Oxygen

PLACEBO COMPARATOR

Other: Oxygen

PEEP + Heliox

EXPERIMENTAL

Other: Heliox; Other: PEEP

Oxygen + PEEP

EXPERIMENTAL

Other: Oxygen; Other: PEEP

Heliox

ACTIVE COMPARATOR

Other: Heliox

Interventions

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.

Oxygen; Oxygen + PEEP

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.

Heliox; PEEP + Heliox

PEEP OTHER

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

Oxygen + PEEP; PEEP + Heliox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Laboratório de Fisiologia e Fisioterapia cardiorespiratória

Recife, Pernambuco, 50670901, Brazil

Location

Related Publications (2)

• 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.

  PMID: 1864100 RESULT

• 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.

  PMID: 7842183 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Oxygen; heliox

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 5, 2013
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 5, 2013

Record last verified: 2012-12

Locations

BR (1)