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

Khon Kaen University

Status: Completed

Conditions: Bronchial Secretion Retention

Treatments: Device: BreatheMAX (OPEP); Device: BreatheMAX (unload and non-oscillated); Device: BreatheMAX (OIS and OPEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT02553200

KKU

Details and patient eligibility

About

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

Full 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

Enrollment: 28 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

28 participants in 3 patient groups

BreatheMAX (OPEP)

Active Comparator group

Description:

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

Treatment:

Device: BreatheMAX (OPEP)

BreatheMAX (OIS and OPEP)

Experimental group

Description:

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

Treatment:

Device: BreatheMAX (OIS and OPEP)

BreatheMAX (unload and non-oscillated)

Sham Comparator group

Description:

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

Treatment:

Device: BreatheMAX (unload and non-oscillated)