Clinical trial NCT02600039: The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients
Official title: The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients: Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-11-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the applicability of the therapeutic resources used. Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial randomized crossover. Volunteers will be included with FC with moderate to severe lung disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (\> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used. The sample is selected by convenience from the database of individuals assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be developed in three phases, divided into three days with an interval of at least 48 hours between phases. The first day will undergo initial assessment and in the days following the intervention by day, ELTGOL or Acapella, in a randomized order.


Eligibility criteria: Inclusion Criteria: Volunteers with Cystic Fibrosis and lung disease with chest hemiperímetro ≥ 37 cm. Exclusion Criteria: Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (\> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used.

Primary outcomes:
measure: Average Electrical Impedance on the End-Expiration
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Dyspnea assessed by the Borg scale
timeFrame: baseline, one minute and thirtieth minutes
measure: Oxygen saturation assessed by oximeter
timeFrame: baseline, one minute and thirtieth minutes
measure: Preferred technique assessed by an open question
timeFrame: up to 3 minutes
measure: Adverse Effects associeted with ELTGOL and Acapella assessed by an open question
timeFrame: baseline, one minute and thirtieth minutes
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
state: Pernambuco
Study officials:
References: