Clinical trial NCT06086730: Comparison Of Blow Bottle Positive Expiratory Pressure (BBPEP) Versus Acapella Among Patient With Chronic Bronchitis
Official title: Comparison Of Blow Bottle Positive Expiratory Pressure (BBPEP) Versus Acapella on Oxygenation ,Peak Expiratory Flow Rate (PEFR) Among Patient With Chronic Bronchitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Bronchitis
Keywords: alveolar collapse,hypersecreation,airway obstruction
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 connective 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 investigator compare the effect of BBPEP and Acapella in participant 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 . participant 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 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. study will be carried out for 8 weeks , 3 days per week. Outcome variables will be Peak flow meter , pulse oximeter ,casa q scale ,heart rate, respiratory rate blood pressure. Data will be analyzed on SPSS-25.

Eligibility criteria: Inclusion Criteria

* Participant having chronic bronchitis both male and female.
* Presence of 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.
* Participant willing to participate.
* Presence of air flow obstruction by spirometry(GOLD stage 2).
* Participant with stable hemodynamic .

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
* Participant with hemodynamic instability having heart rate \>120 bpm.

Primary outcomes:
measure: pulse oximeter
timeFrame: 8 weeks
measure: peak expiratory flow rate (PEFR)
timeFrame: 8 weeks
measure: casa q scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Govt .Mian Meer Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumera abdulhameed, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liverani B, Nava S, Polastri M. An integrative review on the positive expiratory pressure (PEP)-bottle therapy for patients with pulmonary diseases. Physiother Res Int. 2020 Jan;25(1):e1823. doi: 10.1002/pri.1823. Epub 2019 Nov 25.
citation: Widysanto A, Goldin J, Mathew G. Chronic Bronchitis. 2025 Feb 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482437/
citation: Kim V, Criner GJ. Chronic bronchitis and chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2013 Feb 1;187(3):228-37. doi: 10.1164/rccm.201210-1843CI. Epub 2012 Nov 29.
citation: Sehlin M, Ohberg F, Johansson G, Winso O. Physiological responses to positive expiratory pressure breathing: a comparison of the PEP bottle and the PEP mask. Respir Care. 2007 Aug;52(8):1000-5.
citation: Patterson JE, Hewitt O, Kent L, Bradbury I, Elborn JS, Bradley JM. Acapella versus 'usual airway clearance' during acute exacerbation in bronchiectasis: a randomized crossover trial. Chron Respir Dis. 2007;4(2):67-74. doi: 10.1177/1479972306075483.
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.