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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02600039
• Other study ID #: 37906314.3.0000.5208
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2015
• Last updated: November 6, 2015
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• ELTGOL
Individuals will be placed in the lateral decubitus position and instructed to perform slow expirations with an open glottis through a nozzle attached to the mouth from the residual functional capacity to residual volume. Concurrently, a trained and subsequently positioned relative to the voluntary physical therapist will perform a manual compression of the abdominal region dependent and the rib cage to enhance contralateral lung deflation. This intervention is performed so that the time is homogeneous between each repetition interval of one minute between each set. To this end, three sets of ten repetitions will be performed on each lateral decubitus (left and right)

Device:
• Acapella
Participant should be comfortably seated and with his elbows on a table. The mouthpiece is attached properly to not allow leaks. The resistance load will be one in which the individual is able to maintain uninterrupted expiration of 3 seconds. Then the patient will be instructed to inhale slowly and deeply, with lung volumes between the residual volume and total lung capacity. The air exhaled by Acapella is directed toward an orifice which opens and closes periodically, promoting oscillations in the air stream throughout the expiratory phase. The expiration is always performed to the VR, and without performing the active contraction of the abdominal muscles. Still prompted an inspiratory pause of 2 seconds for the end of the inspiratory phase. This procedure will be performed in 4 sets of 5 minutes with interval of 1 minute between the series.

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Integral Professor Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Electrical Impedance on the End-Expiration		up to 30 minutes	Yes
Secondary	Dyspnea assessed by the Borg scale		baseline, one minute and thirtieth minutes	Yes
Secondary	Oxygen saturation assessed by oximeter		baseline, one minute and thirtieth minutes	Yes
Secondary	Preferred technique assessed by an open question		up to 3 minutes	Yes
Secondary	Adverse Effects associeted with ELTGOL and Acapella assessed by an open question		baseline, one minute and thirtieth minutes	Yes