The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function

NCT ID: NCT02553200

Last Updated: 2018-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-02-28

Brief Summary

The efficacy of breathing exercise with oscillated inspiratory loading and oscillated positive expiratory pressure for airway secretion clearance and lung function in intubated patients, both with and without mechanical ventilation dependence

Detailed Description

Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors.

1. Oscillation at proper frequency.

2. Lung volume and airway opening.

3. Expiratory flow rate or expiratory bias.

4. Humidifying of inspired air.

Multifunctional breathing device, the BreatheMAX, is the only breathing device made in Thailand. The BreatheMAX device possess many properties or techniques that benefit for respiratory care particularly 3 in 4 mechanisms for secretion clearance. The unique important aspect is the simultaneously providing several beneficial effects in one breath which are 1) Oscillation in the range of ciliary beat frequency 2) Biofeedback of respiratory effort that could encourage the deeper breathing performance, 3) Humidifier of inspired air, 4) Loaded breathing for inspiratory muscle training and generate PEP. These 4 functions would be very useful for increase secretion clearance particularly in more peripheral airway which are the most difficult to be cleared and be a risk of atelectasis and infection in patients with MV whose natural secretion clearance mechanisms are compromised, respiratory muscle weakness weak and low immunity.

Therefore, the combination of inspiratory and expiratory breathing exercise through the BreatheMAX breathing device may increase or promote more secretion clearance and improve lung function than expiratory breathing exercise alone in intubated patients, both with and without mechanical ventilation dependence

Conditions

Bronchial Secretion Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BreatheMAX (OPEP)

for 10 breathes/set, 10 sets/day and rest 1 minute between set

Group Type: ACTIVE_COMPARATOR

BreatheMAX (OPEP)

Intervention Type: DEVICE

for 10 breathes/set, 10 sets/day and rest 1 minute between set

BreatheMAX (OIS and OPEP)

for 10 breathes/set, 10 sets/day and rest 1 minute between set

Group Type: EXPERIMENTAL

BreatheMAX (OIS and OPEP)

Intervention Type: DEVICE

for 10 breathes/set, 10 sets/day and rest 1 minute between set

BreatheMAX (unload and non-oscillated)

inspiratory and expiratory breathing exercise for 10 breathes/set, 10 sets/day and rest 1 minute between set

Group Type: SHAM_COMPARATOR

BreatheMAX (unload and non-oscillated)

Intervention Type: DEVICE

for 10 breathes/set, 10 sets/day and rest 1 minute between set

Interventions

BreatheMAX (OPEP)

for 10 breathes/set, 10 sets/day and rest 1 minute between set

Intervention Type: DEVICE

BreatheMAX (OIS and OPEP)

for 10 breathes/set, 10 sets/day and rest 1 minute between set

Intervention Type: DEVICE

BreatheMAX (unload and non-oscillated)

for 10 breathes/set, 10 sets/day and rest 1 minute between set

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following
• Clinical and radiologic diagnosis of pulmonary infection
• Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound
• Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data
• Stable of hydration status or positive fluid balance at least 2 days before collects the data
• Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 2 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia
• Good conscious and well cooperation

Exclusion Criteria

• Pneumothorax (nontreated)
• Massive hemoptysis
• Acute myocardial infarction (with angina chest pain)
• High intracranial pressure (>20 mm Hg)
• Major arrhythmia

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Sujittra Kluayhomthong

123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chulee Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

The Faculty of Associated Medical Sciences Khon Kaen University 123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand

Locations

Sujittra Kluayhomthong

Khon Kaen, , Thailand

Countries

Thailand

Other Identifiers

KKU

Identifier Type: -

Identifier Source: org_study_id