The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance

Lung Disease Clinical Trial

— ESMOSC  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01090804
• Other study ID #: 47660279
• Status: Unknown status
• Phase: Phase 2/Phase 3
• First received: January 7, 2010
• Last updated: March 22, 2010
• Start date: August 2009

Study information

• Verified date: January 2010
• Source: Khon Kaen University
• Contact: Miss Sujittra Kluayhomthong, Bachelor
• Phone: 081-379-0647
• Email: rabbit_tigger[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 14
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

Inclusion Criteria:

• One sign of secretion accumulation in bronchi

• Stable cardiopulmonary function

• Good consciousness and good co-operation

Exclusion Criteria:

• Massive hemoptysis

• Pneumothorax (untreated)

Related Conditions & MeSH terms

• Lung Disease
• Lung Diseases
• Respiratory Aspiration

Intervention

Device:
• BreatheMAX breathing device
secretion clearance, breathing exercise

Locations

Country	Name	City	State
Thailand	Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University	Muang	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)
Primary	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	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
Secondary	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
Secondary	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)