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

NCT02600039 | Unknown DMC

• 1 other identifier: 37906314.3.0000.5208
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Average Electrical Impedance on the End-Expiration

  up to 30 minutes

Secondary Outcomes (4)

• 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

Study Arms (2)

ELTGOL

EXPERIMENTAL

Other: ELTGOL; Device: Acapella

Acapella

ACTIVE COMPARATOR

Other: ELTGOL; Device: Acapella

Interventions

ELTGOL OTHER

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)

Acapella; ELTGOL

Acapella DEVICE

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.

Acapella; ELTGOL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Pernambuco, Brazil

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 9, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 9, 2015

Record last verified: 2015-11

Locations

BR (1)