The Effectiveness of BreatheMAX Breathing Device on Secretion Clearance

NCT01090804 | Unknown Phase 2 DMC

• 1 other identifier: 47660279
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Disease

Keywords

BreatheMAX breathing device; Secretion clearance; Ventilatory dependence; Intubated patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Heart rate (beat/min)

  Before, during breathing exercise with device and immediate after treatment

• Oxygen saturation (%SpO2)

  Before, during breathing exercise with device and immediate after treatment

• Respiratory rate (times/min)

  In rest interval between set (1 minute)

Study Arms (1)

breathing exercise

EXPERIMENTAL

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

Interventions

BreatheMAX breathing device DEVICE

secretion clearance, breathing exercise

breathing exercise

Eligibility Criteria

• Age: 15 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Massive hemoptysis
• Pneumothorax (untreated)

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Pulmonary research room of physical therapy department, Faculty of associated medical sciences, Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Sujittra Kluayhomthong, Bachelor

  Physical Therapy department, Faculty of Associated Medical Sciences, Khon Kaen university

  STUDY CHAIR

• Chulee CU Jones, Philosophy

  Physical Therapy Department, Faculty of Associated Medical Sciences, Khon Kaen university, Thailand

  STUDY DIRECTOR

• Wilaiwan Khrisanapant, Philosophy

  Department of physiology, Faculty of medicine, Khon Kaen university

  STUDY DIRECTOR

Central Study Contacts

Miss Sujittra Kluayhomthong, Bachelor

CONTACT

081-379-0647; rabbit_tigger@hotmail.com

Mrs. Chulee Jones, Philosophy

CONTACT

664-320-2399; Chujones46@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: March 23, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: March 23, 2010

Record last verified: 2010-01

Locations

TH (1)