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

Primary Purpose

Bronchial Secretion Retention

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
BreatheMAX (OPEP)
BreatheMAX (OIS and OPEP)
BreatheMAX (unload and non-oscillated)
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Secretion Retention focused on measuring intubated patients, secretion clearance, lung function, breathing exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sujittra Kluayhomthong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

BreatheMAX (OPEP)

BreatheMAX (OIS and OPEP)

BreatheMAX (unload and non-oscillated)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program
The mucus secretion will be collected by nursing staff using sterile suctioning technique via tracheostomy (TT) or endotracheal (ET) tube, without adding any saline or sterile water, the timing of suction procedure depend on the secretion sound in the ET and TT tube.

Secondary Outcome Measures

change from baseline in dynamic compliance (Cdyn) at end of breathing exercise program
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the data will be recorded from the mechanical ventilator monitoring during the patients breathing with mechanical ventilation (MV) at least 1 minute
change from baseline in peak inspiratory pressure (PIP) at end of breathing exercise program
as follows: Cdy, PIP,VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the data will be recorded from the mechanical ventilator monitoring during the patients breathing with mechanical ventilation at least 1 minute
change from baseline in expired minute ventilation (VE) at end of breathing exercise program
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the wright respirometer will be connected with ET or TT tube during spontaneous breathing (off MV) for 1 minute, three measurement will be measured and rest 1 minute by using mechanical ventilation
change from baseline in slow vital capacity (SVC) at end of breathing exercise program
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the wright respirometer will be connected with ET or TT tube during spontaneous breathing (off MV), three measurement will be measured and rest 1 minute by using mechanical ventilation
change from baseline in lung sound at the end of breathing exercise program
as follows: Cdy, PIP, PNIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the electronic stethoscope will be used to record the lung sound in each area during breathing with mechanical ventilation
change from baseline in Rating of Perceived Exertion (RPE) and Rating of Perceived Breathlessness (RPB) at the end of breathing exercise program
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response using the dyspnea and exertion scale
change from baseline in heart rate at the end of breathing exercise program
the data will be recorded every minute
change from baseline in partial pressure of oxygen saturation at the end of breathing exercise program
the data will be recorded every minute
change from baseline in respiratory rate at the end of breathing exercise program
the data will be recorded every minute
change from baseline in blood pressure at the end of breathing exercise program

Full Information

First Posted
May 13, 2015
Last Updated
August 16, 2018
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT02553200
Brief Title
The Efficacy of Breathing Exercise With BreatheMAX Device on Airway Secretion Clearance and Lung Function
Acronym
BMACPF
Official Title
Study of Breathing Exercise With Oscillated Inspiratory Loading (OIS) and Oscillated Positive Expiratory Pressure (OPEP) for Airway Secretion Clearance and Lung Function in Intubated Patients, Both With and Without Mechanical Ventilatory Support
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
Effective strategies to increase mucus clearance rate has been suggested to depend on 4 factors. Oscillation at proper frequency. Lung volume and airway opening. Expiratory flow rate or expiratory bias. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Secretion Retention
Keywords
intubated patients, secretion clearance, lung function, breathing exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BreatheMAX (OPEP)
Arm Type
Active Comparator
Arm Description
for 10 breathes/set, 10 sets/day and rest 1 minute between set
Arm Title
BreatheMAX (OIS and OPEP)
Arm Type
Experimental
Arm Description
for 10 breathes/set, 10 sets/day and rest 1 minute between set
Arm Title
BreatheMAX (unload and non-oscillated)
Arm Type
Sham Comparator
Arm Description
inspiratory and expiratory breathing exercise for 10 breathes/set, 10 sets/day and rest 1 minute between set
Intervention Type
Device
Intervention Name(s)
BreatheMAX (OPEP)
Intervention Description
for 10 breathes/set, 10 sets/day and rest 1 minute between set
Intervention Type
Device
Intervention Name(s)
BreatheMAX (OIS and OPEP)
Intervention Description
for 10 breathes/set, 10 sets/day and rest 1 minute between set
Intervention Type
Device
Intervention Name(s)
BreatheMAX (unload and non-oscillated)
Intervention Description
for 10 breathes/set, 10 sets/day and rest 1 minute between set
Primary Outcome Measure Information:
Title
change from baseline in secretion wet weight (gram) between 3 hours before and after breathing exercise program
Description
The mucus secretion will be collected by nursing staff using sterile suctioning technique via tracheostomy (TT) or endotracheal (ET) tube, without adding any saline or sterile water, the timing of suction procedure depend on the secretion sound in the ET and TT tube.
Time Frame
the secretion will be collected between 3 hours before start breathing exercise program and 3 hours after end of breathing exercise program in each day
Secondary Outcome Measure Information:
Title
change from baseline in dynamic compliance (Cdyn) at end of breathing exercise program
Description
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the data will be recorded from the mechanical ventilator monitoring during the patients breathing with mechanical ventilation (MV) at least 1 minute
Time Frame
within 30 minutes before breathing exercise and 30 minute after breathing exercise
Title
change from baseline in peak inspiratory pressure (PIP) at end of breathing exercise program
Description
as follows: Cdy, PIP,VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the data will be recorded from the mechanical ventilator monitoring during the patients breathing with mechanical ventilation at least 1 minute
Time Frame
within 30 minutes before breathing exercise and 30 minute after breathing exercise
Title
change from baseline in expired minute ventilation (VE) at end of breathing exercise program
Description
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the wright respirometer will be connected with ET or TT tube during spontaneous breathing (off MV) for 1 minute, three measurement will be measured and rest 1 minute by using mechanical ventilation
Time Frame
within 30 minutes before breathing exercise and 30 minute after breathing exercise
Title
change from baseline in slow vital capacity (SVC) at end of breathing exercise program
Description
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the wright respirometer will be connected with ET or TT tube during spontaneous breathing (off MV), three measurement will be measured and rest 1 minute by using mechanical ventilation
Time Frame
within 30 minutes before breathing exercise and 30 minute after breathing exercise
Title
change from baseline in lung sound at the end of breathing exercise program
Description
as follows: Cdy, PIP, PNIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response the electronic stethoscope will be used to record the lung sound in each area during breathing with mechanical ventilation
Time Frame
within 30 minutes before breathing exercise and 30 minute after breathing exercise
Title
change from baseline in Rating of Perceived Exertion (RPE) and Rating of Perceived Breathlessness (RPB) at the end of breathing exercise program
Description
as follows: Cdy, PIP, VE, SVC, PEFR, Lung sound, RPE and RPB and cardiopulmonary response using the dyspnea and exertion scale
Time Frame
within 30 minutes before breathing exercise and 30 minute after breathing exercise
Title
change from baseline in heart rate at the end of breathing exercise program
Description
the data will be recorded every minute
Time Frame
5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
Title
change from baseline in partial pressure of oxygen saturation at the end of breathing exercise program
Description
the data will be recorded every minute
Time Frame
5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
Title
change from baseline in respiratory rate at the end of breathing exercise program
Description
the data will be recorded every minute
Time Frame
5 minutes before breathing exercise and during breathing exercise and 5 minute after breathing exercise
Title
change from baseline in blood pressure at the end of breathing exercise program
Time Frame
5 minutes before breathing exercise and 5 minute after breathing exercise

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulee Jones, PhD
Organizational Affiliation
The Faculty of Associated Medical Sciences Khon Kaen University 123 Moo 16 Mittapap Road Nai-Muang, Muang District Khon Kaen 40002, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sujittra Kluayhomthong
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

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

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