The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determined effects of BreatheMAX on secretion clearance.

Official Title
-----------------
The Effectiveness of BreatheMAX Breathing Device on Airway Secretion Clearance in Patients With Ventilatory Dependence

Conditions
-----------------
Lung Disease

Intervention / Treatment
-----------------
* Device: BreatheMAX breathing device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One sign of secretion accumulation in bronchi Stable cardiopulmonary function Good consciousness and good co-operation Exclusion Criteria: Massive hemoptysis Pneumothorax (untreated)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: breathing exercise<br>BreatheMAX breathing device is Water pressure Threshold Bottle. The level of water in the cylinder determines the load for treatment. In the treatment using 20% PNIP (Peak negative inspiratory pressure) was performed with 6-10 breaths/set; 10 set/day | Device: BreatheMAX breathing device<br>* secretion clearance, breathing exercise<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secretion wet weight (gram) | Airway mucus secretion was collected for three hours before and ten hours after treatment based on an auditory airway secretion sound and collected again at 02.00-07.00 am.The mucus secretion was collected by sterile suctioning technique via tracheostomy tube without adding any saline or sterile water. | Three hours before, ten hours after treatment and night-time (02.00-07.00 am.) | 
| viscosity of secretion | The secretion were collected in three hours before and after treatment, It were measured viscosity by First The mucus was gently homogenized by tissue grinder 5 ml (Cw11-205, Cowie, UK) for six minute at 37 degree celsius Second using Micro-Oswald viscometers with a capillary diameter of 0.77 mm for viscosity measure at same temperature in each sample(before and after). | Three hours before and after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate (beat/min) | Heart rate was monitored before, during and immediate after breathing exercise with BreatheMAX (6-10 beats/set, 10 set/day and rest between ste for 1 minute) | Before, during breathing exercise with device and immediate after treatment | 
| Oxygen saturation (%SpO2) | Oxygen saturation was monitored before, during and immediate after breathing exercise with BreatheMAX (6-10 beats/set, 10 set/day and rest between set for 1 minute) | Before, during breathing exercise with device and immediate after treatment | 
| Respiratory rate (times/min) | Respiratory rate was measured by manual for 1 minute before, rest interval between set and immediate after breathing exercise with device (during the patients reconnection mechanical ventilation) | In rest interval between set (1 minute) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BreatheMAX breathing device, Secretion clearance, Ventilatory dependence, Intubated patients