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Comparison of Blow Bottle Positive Expiratory Pressure(BBPEP) Versus Acapella Among Patient With Chronic Bronchitis

Primary Purpose

Chronic Bronchitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
blow bottle positive expiratory pressure
acapella
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Bronchitis focused on measuring airway narrowing,alveolar collapse,hyper secreation

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria patient present with chronic bronchitis I-e daily cough and sputum production for at least 3 months each year during the past 2 years. Current smoker or ex smoker with 5 packs years of smoking history. Patients who is willing to participate in study. Presence of air flow obstruction by spirometry(GOLD stage 2) . patients with stable hemodynamics. Exclusion Criteria: History of cough syncope. participant who required intubation. Participant who is critically ill. Participant who required functional dependency. Participant having angina at rest or in minor effort. Participant having cardiac arrhythmia. Participant having severe airway obstruction I-e GOLD stage 4

Sites / Locations

  • Govt .Mian Meer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

blow bottle positive expiratory pressure

acapella

Arm Description

Water was poured into a 1 L plastic container until it reached a 10 cm height. A 30 cm long tube was put into the water in the bottle, 8 cm deep. The participants were instructed to close their mouths around the tubing in the apparatus for three seconds to produce bubbles, do this for a total of 10 breaths, perform two huffs, then cough. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized

Make sure the frequency adjustment dial has been rotated counterclockwise to the lowest frequency-resistance setting before using the Acapella for the first time. On a chair, adopt a straight stance. maintaining a straight back and relaxing your elbows on a table. Now gradually tilt your head upward to maintain the opening of your upper airways. Inhale more deeply than you frequently do. Make sure your lips are encircling the mouthpiece, then blow into the device with a strong expiration. You should ideally blow out roughly twice as quickly as usual. For around ten breaths. Make careful to expel to clear the secretions from the airways after the final try. You can even conduct 2 to 3 "huffs" to improve secretion elimination when necessary. It should be noted that while using the device, you must be capable of exhale for a minimum of three to four seconds.

Outcomes

Primary Outcome Measures

pulse oximeter
Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.
peak expiratory flow rate (PEFR)
Peak expiratory flow rate is the volume of air expelled from the lungs in one quick exhalation and is reliable indicator of ventillation adequacy as well as air flow obstruction .The normal peak flow value can range from person to person and is dependent upon factors such as sex ,age height

Secondary Outcome Measures

Full Information

First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06086730
Brief Title
Comparison of Blow Bottle Positive Expiratory Pressure(BBPEP) Versus Acapella Among Patient With Chronic Bronchitis
Official Title
Comparison of Blow Bottle Positive Expiratory Pressure (BBPE) Versus Acapella on Oxygenation,Peak Expiratory Flow Rate (PEFR) Among Patient With Chronic Bronchitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison of Blow Bottle Positive Expiratory pressure(BBPEP) versus Acapella on Oxygenation ,peak Expiratory Flow Rate(PEFR)among patient with chronic bronchitis.
Detailed Description
Worldwide most of the people belong to all age group may affected with Non communicable diseases(NCD) which leads them toward death globally . According to stats World Health Organization (WHO) declares about 41 million people are died due to NCD which means about 71 %people are died globally due to this .Chronic Respiratory diseases are one of the main non communicable disease . About 9.0 million(3.6%) adult belong to age group of 18 or older may suffer from chronic bronchitis . Hallmark of chronic bronchitis is that cough and sputum production for more than >3months in each of at least two consecutive years. Chronic bronchitis effects every third person having COPD but it may effect any body who had normal pulmonary functions. Now a days positive expiratory pressure (PEP)devices are used along Cardio Pulmonary Therapy(CPT) .PEP devices are help full in mobilize the secretion in lower respiratory tract , may also beneficial in collateral ventilation ,mucous secretion and most importantly optimize functional residual capacity among people who had pulmonary complications. Many PEP devices are available in market but BBPEP is in low cost and are easily in approach of every single person .PEP is non invasive technique used to improve clinical outcome . In this study we compare the effect of BBPEP and Acapella in patient having chronic bronchitis In case of BBPEP patient expires against resistance of water column which increase PEP ( positive expiratory pressure ) in inlet which transferred airway patients lungs this will keep the alveoli patent or may recruit the collapsed alveoli. This will decrease airway resistance and improve lung compliance . As airway resistance decreases the amount of SPO2 AND PEFR also improved . people are randomly assigned into two different group GROUP(A) AND GROUP(B) Group (A) receive intervention by using BBPEP device along with deep breathing exercises Water was poured into a 1 L plastic container until it reached a 10 cm height. A 30 cm long tube was put into the water in the bottle, 8 cm deep. The participants were instructed to close their mouths around the tubing in the apparatus for three seconds to produce bubbles, do this for a total of 10 breaths, perform two huffs, then cough. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized, Because it is a homemade device and can be used with less equipment and with more ease at home, the blow bottle device is more affordable than other devices. When a patient performs BBPEP, the patient must exhale against the resistance of the water column, which causes an increase in expiratory phase time and flow but a constant PEP or an increase in PEP that could be hazardous because we employed tubing with an inner diameter of about 8 mm. It causes the alveoli to enlarge, and more air enters the space behind the mucus through collateral routes, pushing the mucus toward the center. As a result, collateral ventilation has improved, making it easier to clear the airways and prevent alveolar collapse. SpO2 and PEFR eventually improve as a result. Today, PEP therapy is used as a supplement to CPT because it has additional benefits like improving collateral ventilation, enhancing secretion clearance, amplifying aerosol distribution, and optimizing functional residual capacity, which is compromised in conditions following cardiac surgery. There are many PEP devices available, however they are more expensive than BBPEP devices, which are less expensive and more widely accessible Group (B)participant use acapella devices so out come will be measured participant rotate the device toward positive(+) sign to increase resistance or may rotate device to minus (-) to decrease resistance participant is in comfortable short sitting position ask him to take deep breath and hold it for 3 sec nose clip attached to the participant participant lips sealed mouthpiece ask him to exhale into mouth piece maneuver repeated for 10 to 12 breath with 3 to 4 huffs all the steps repeated for 15 minute .Both groups perform session for three day for 8 weeks , each session took 35to 40 minutes .outcome variable will be oxygen saturation and peak expiratory flow rate,respiratory rate, blood pressure,heart rate. Data will be inquire into on spss -25

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Bronchitis
Keywords
airway narrowing,alveolar collapse,hyper secreation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
blow bottle positive expiratory pressure
Arm Type
Experimental
Arm Description
Water was poured into a 1 L plastic container until it reached a 10 cm height. A 30 cm long tube was put into the water in the bottle, 8 cm deep. The participants were instructed to close their mouths around the tubing in the apparatus for three seconds to produce bubbles, do this for a total of 10 breaths, perform two huffs, then cough. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized
Arm Title
acapella
Arm Type
Active Comparator
Arm Description
Make sure the frequency adjustment dial has been rotated counterclockwise to the lowest frequency-resistance setting before using the Acapella for the first time. On a chair, adopt a straight stance. maintaining a straight back and relaxing your elbows on a table. Now gradually tilt your head upward to maintain the opening of your upper airways. Inhale more deeply than you frequently do. Make sure your lips are encircling the mouthpiece, then blow into the device with a strong expiration. You should ideally blow out roughly twice as quickly as usual. For around ten breaths. Make careful to expel to clear the secretions from the airways after the final try. You can even conduct 2 to 3 "huffs" to improve secretion elimination when necessary. It should be noted that while using the device, you must be capable of exhale for a minimum of three to four seconds.
Intervention Type
Device
Intervention Name(s)
blow bottle positive expiratory pressure
Intervention Description
Water was poured into a 1 L plastic container until it reached a 10 cm height. A 30 cm long tube was put into the water in the bottle, 8 cm deep. The participants were instructed to close their mouths around the tubing in the apparatus for three seconds to produce bubbles, do this for a total of 10 breaths, perform two huffs, then cough. Such exhalations were conducted in two sets of ten, with a five-minute pause in between. For each subject, a fresh, disposable tube and bottle were utilized,Because it is a homemade device and can be used with less equipment and with more ease at home . patient perform session three day per week for the duration of 8 weeks , each session last for 35-40 minutes.
Intervention Type
Device
Intervention Name(s)
acapella
Intervention Description
Make sure the frequency adjustment dial has been rotated counterclockwise to the lowest frequency-resistance setting before using the Acapella for the first time.On a chair, adopt a straight stance. maintaining a straight back and relaxing your elbows on a table. Now gradually tilt your head upward to maintain the opening of your upper airways.Inhale more deeply than you frequently do. Make sure your lips are encircling the mouthpiece, then blow into the device with a strong expiration.You should ideally blow out roughly twice as quickly as usual.For around ten breaths, keep going like this.Make careful to expel to clear the secretions from the airways after the final try. You can even conduct 2 to 3 "huffs" to improve secretion elimination when necessary.It should be noted that while using the device, you must be capable of exhale for a minimum of three to four seconds. patient perform session three day per week for the duration of 8 weeks , each session last for 35-40 minutes
Primary Outcome Measure Information:
Title
pulse oximeter
Description
Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.
Time Frame
8 weeks
Title
peak expiratory flow rate (PEFR)
Description
Peak expiratory flow rate is the volume of air expelled from the lungs in one quick exhalation and is reliable indicator of ventillation adequacy as well as air flow obstruction .The normal peak flow value can range from person to person and is dependent upon factors such as sex ,age height
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria patient present with chronic bronchitis I-e daily cough and sputum production for at least 3 months each year during the past 2 years. Current smoker or ex smoker with 5 packs years of smoking history. Patients who is willing to participate in study. Presence of air flow obstruction by spirometry(GOLD stage 2) . patients with stable hemodynamics. Exclusion Criteria: History of cough syncope. participant who required intubation. Participant who is critically ill. Participant who required functional dependency. Participant having angina at rest or in minor effort. Participant having cardiac arrhythmia. Participant having severe airway obstruction I-e GOLD stage 4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumera abdulhameed, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Govt .Mian Meer Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumera Adulhameed, MS
Phone
03104548492
Email
sumera.hameed@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Shazia Nawaz, MSCPPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
8980973
Citation
Soguel Schenkel N, Burdet L, de Muralt B, Fitting JW. Oxygen saturation during daily activities in chronic obstructive pulmonary disease. Eur Respir J. 1996 Dec;9(12):2584-9. doi: 10.1183/09031936.96.09122584.
Results Reference
background
PubMed Identifier
15655681
Citation
Wirtz HR. [Chronic bronchitis, COPD]. Internist (Berl). 2005 Feb;46(2):175-91; quiz 192-3. doi: 10.1007/s00108-004-1335-z. German.
Results Reference
background
PubMed Identifier
29531450
Citation
Sharma P, Prem V, Jain S. Immediate Effects of Acapella(R) on Dynamic Lung Compliance in Mechanically Ventilated Patients with Acute Respiratory Distress Syndrome: A Case Series. Indian J Crit Care Med. 2018 Feb;22(2):100-102. doi: 10.4103/ijccm.IJCCM_157_17.
Results Reference
background
PubMed Identifier
36978035
Citation
Chen X, Li C, Zeng L, Rong T, Lin P, Wang Q, Guo Z, Long H, Zhong J. Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial. BMC Cancer. 2023 Mar 28;23(1):282. doi: 10.1186/s12885-023-10750-4.
Results Reference
background
PubMed Identifier
37560172
Citation
Jage B, Thakur A. Effectiveness of Acapella along with institutional based chest physiotherapy techniques on pulmonary functions and airway clearance in post-operative CABG patients. Hong Kong Physiother J. 2022 Dec;42(2):81-89. doi: 10.1142/S101370252250007X. Epub 2022 Jun 15.
Results Reference
background
PubMed Identifier
9112303
Citation
Bjorkqvist M, Wiberg B, Bodin L, Barany M, Holmberg H. Bottle-blowing in hospital-treated patients with community-acquired pneumonia. Scand J Infect Dis. 1997;29(1):77-82. doi: 10.3109/00365549709008669.
Results Reference
background
PubMed Identifier
16304303
Citation
Westerdahl E, Lindmark B, Eriksson T, Friberg O, Hedenstierna G, Tenling A. Deep-breathing exercises reduce atelectasis and improve pulmonary function after coronary artery bypass surgery. Chest. 2005 Nov;128(5):3482-8. doi: 10.1378/chest.128.5.3482.
Results Reference
background

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Comparison of Blow Bottle Positive Expiratory Pressure(BBPEP) Versus Acapella Among Patient With Chronic Bronchitis

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