The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients

Not Applicable

• Conditions: Cystic Fibrosis
• Interventions: Other: ELTGOL; Device: Acapella

• Registration Number: NCT02600039
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-29
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-06
• Last Update Submitted: 2015-11-06
• Study First Posted: 2015-11-09
• Last Update Posted: 2015-11-09
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ELTGOL	Acapella	-
Acapella	ELTGOL	-
ELTGOL	ELTGOL	-
Acapella	Acapella	-

Primary Outcome Measures

Name	Time	Method
Average Electrical Impedance on the End-Expiration	up to 30 minutes

Secondary Outcome Measures

Name	Time	Method
Dyspnea assessed by the Borg scale	baseline, one minute and thirtieth minutes
Oxygen saturation assessed by oximeter	baseline, one minute and thirtieth minutes
Preferred technique assessed by an open question	up to 3 minutes
Adverse Effects associeted with ELTGOL and Acapella assessed by an open question	baseline, one minute and thirtieth minutes

Trial Locations

Locations (1)

Instituto de Medicina Integral Professor Fernando Figueira; 🇧🇷 Recife, Pernambuco, Brazil