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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06086730
Collaborator
(none)
36
1
2
2.7
13.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: blow bottle positive expiratory pressure
  • Device: acapella
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Blow Bottle Positive Expiratory Pressure (BBPE) Versus Acapella on Oxygenation,Peak Expiratory Flow Rate (PEFR) Among Patient With Chronic Bronchitis
Actual Study Start Date :
Sep 20, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: blow bottle positive expiratory pressure

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

Device: blow bottle positive expiratory pressure
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.

Active Comparator: acapella

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.

Device: acapella
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

Outcome Measures

Primary Outcome Measures

  1. pulse oximeter [8 weeks]

    Pulse oximeter that measures the proportion of oxygenated hemoglobin in the blood in pulsating vessels, especially the capillaries of the finger or ear.

  2. peak expiratory flow rate (PEFR) [8 weeks]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Govt .Mian Meer Hospital Lahore Punjab Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Sumera abdulhameed, MS, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT06086730
Other Study ID Numbers:
  • REC/0347
First Posted:
Oct 17, 2023
Last Update Posted:
Oct 17, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023