The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance

Phase 2

• Conditions: Lung Disease
• Interventions: Device: BreatheMAX breathing device

• Registration Number: NCT01090804
• Lead Sponsor: Khon Kaen University

Brief Summary

The purpose of this study is to determined effects of BreatheMAX on secretion clearance.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2009-12
• Status Verified: 2010-01
• Study First Submitted: 2010-01-07
• Study First Submitted QC: 2010-03-22
• Last Update Submitted: 2010-03-22
• Study First Posted: 2010-03-23
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• One sign of secretion accumulation in bronchi
• Stable cardiopulmonary function
• Good consciousness and good co-operation

Exclusion Criteria

• Massive hemoptysis
• Pneumothorax (untreated)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
breathing exercise	BreatheMAX breathing device	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

Primary Outcome Measures

Name	Time	Method
secretion wet weight (gram)	Three hours before, ten hours after treatment and night-time (02.00-07.00 am.)	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.
viscosity of secretion	Three hours before and after treatment	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).

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation (%SpO2)	Before, during breathing exercise with device and immediate after treatment	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)
Heart rate (beat/min)	Before, during breathing exercise with device and immediate after treatment	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)
Respiratory rate (times/min)	In rest interval between set (1 minute)	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)

Trial Locations

Locations (1)

Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University; 🇹🇭 Muang, Khon Kaen, Thailand