NCT06086730

Brief Summary

Comparison of Blow Bottle Positive Expiratory pressure(BBPEP)versus acapella on Oxygenation ,peak Expiratory Flow Rate(PEFR)among patient with chronic bronchitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

October 11, 2023

Last Update Submit

December 26, 2023

Conditions

Keywords

alveolar collapse,hypersecreation,airway obstruction

Outcome Measures

Primary Outcomes (3)

  • 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.

    8 weeks

  • 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

    8 weeks

  • casa q scale

    The cough and sputum assessment questionnaire (CASA-Q) was used to measure the severity and impact of cough and sputum in patients with COPD and chronic bronchitis. CASA-Q scores of each domain demonstrated significant association with HRQoL impairment CASA-Q was strongly lower when chronic bronchitis was present, but multivariate analyses demonstrated that the association of HRQoL impairment was greater with the cough impact domain score than with the usual definition of chronic bronchitis. The CASA-Q targets cough and sputum by an original approach assessing both the symptoms and impacts in dailyactivities within the last 7 days. Each item is answered ranging from never to always or from not at all to a lot / extremely as applicable each type is answered using five categories.

    8 weeks

Study Arms (2)

blow bottle positive expiratory pressure

EXPERIMENTAL

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

acapella

ACTIVE COMPARATOR

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

Interventions

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.

blow bottle positive expiratory pressure
acapellaDEVICE

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

acapella

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Govt .Mian Meer Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 31762162BACKGROUND
  • 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/

    PMID: 29494044BACKGROUND
  • 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.

    PMID: 23204254BACKGROUND
  • 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.

    PMID: 17650355BACKGROUND
  • 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.

    PMID: 17621572BACKGROUND
  • 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.

    PMID: 29531450BACKGROUND

MeSH Terms

Conditions

Bronchitis, Chronic

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sumera abdulhameed, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

July 20, 2023

Primary Completion

December 1, 2023

Study Completion

December 10, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations