Community-acquired PneumoniaNCT05356494
Postural Drainage and PEP Technique in Community Acquired Pneumonia
A study testing Postural drainage and Positive expiratory pressure in people with Community-acquired Pneumonia, run by Riphah International University at 1 site in Pakistan.
Trial summary
Community-acquired pneumonia is acquired outside the hospital. Postural drainage is the positioning of a patient with an involved lung segment such that gravity has a maximal effect of facilitating the drainage of Broncho-pulmonary secretions from the tracheobronchial tree. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Postural drainage and Positive expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2021to 20 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with community acquired pneumonia.
- Clinically stable patients.
- Both genders
- Age 30 to 70 years
Who cannot join
- Presence of any genetic disorders (cystic fibrosis).
- Recent spinal / chest surgery
- Cardiac issues
- Fractures of vertebra caused by osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons Effects of Postural Drainage and Positive Expiratory Pressure Technique in Community Acquired Pneumonia.
Community-acquired pneumonia is acquired outside the hospital. Postural drainage is the positioning of a patient with an involved lung segment such that gravity has a maximal effect of facilitating the drainage of Broncho-pulmonary secretions from the tracheobronchial tree. It is based on the concept of gravity-assisted mobilization of secretions and transports it for removal. The objective of the study to find the effect of postural drainage and positive expiratory pressure techniques (PEP) to improve the air way clearance and breathing in pneumonia patients. This study will be a RCT and will be conducted in Services Hospital. The study will be completed within the duration of six month. Consecutive sampling study technique will be used to collect the data. The sample size of 46 patients will be taken. Patients will be divided into two groups. (Group A will be treated with postural drainage and Group B will be treated with positive expiratory pressure technique). Outcome measure will be taken on Pulse oximeter, incentive spirometer and chest X- Ray. A regular follow up visits to department and a final assessment was made at the end of four week. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro- Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
- Conditions
- Community-acquired Pneumonia
- Being tested
- Postural drainage, Positive expiratory pressure
- Keywords
- Pneumonia,, Postural Drainage, Positive Expiratory Pressure
- Medical subject headings
- Community-Acquired Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural drainageOther
(Group A will be treated with postural drainage)
Positive expiratory pressureOther
(Group B will be treated with positive expiratory pressure technique).
| Study group | Role | What they receive |
|---|---|---|
| postural drainage | Experimental | (Group A will be treated with postural drainage) Receives: Other: Postural drainage |
| positive expiratory pressure technique | Experimental | (Group B will be treated with positive expiratory pressure technique). Receives: Other: Positive expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCENTIVE SPIROMETER
An incentive spirometer is a handheld device that helps your lungs recover after a surgery or lung illness. When you breathe from an incentive spirometer, a piston rises inside the device and measures the volume of your breath. A healthcare provider can set a target breath volume for you to hit.
Measured: 1 Last week
OXYGEN SATURATION
Oxygen saturation, or "O2 sates," indicates that amount of oxygen traveling through your body with your red blood cells. Normal oxygen saturation is usually between 95% and 100% for most health.
Measured: 1 Last week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start15 Sep 2021
- Primary completion10 Feb 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study concluded that both techniques are effective in improving oxygen saturation and reported statistically significant differences, but no other parameter was statistically improved.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sidra Faisal, MS.CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356494
- Sponsor's protocol ID
- REC/Lhr/22/0318 M Ahmad
- Status last verified
- Dec 2022
- First submitted
- 28 Apr 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li L, Qin L, Xu Z, Yin Y, Wang X, Kong B, Bai J, Lu Y, Fang Z, Song Q, Cao K, Liu D, Wang G, Xu Q, Fang X, Zhang S, Xia J, Xia J. Using Artificial Intelligence to Detect COVID-19 and Community-acquired Pneumonia Based on Pulmonary CT: Evaluation of the Diagnostic Accuracy. Radiology. 2020 Aug;296(2):E65-E71. doi: 10.1148/radiol.2020200905. Epub 2020 Mar 19.
PubMed 32191588Ouyang X, Huo J, Xia L, Shan F, Liu J, Mo Z, Yan F, Ding Z, Yang Q, Song B, Shi F, Yuan H, Wei Y, Cao X, Gao Y, Wu D, Wang Q, Shen D. Dual-Sampling Attention Network for Diagnosis of COVID-19 From Community Acquired Pneumonia. IEEE Trans Med Imaging. 2020 Aug;39(8):2595-2605. doi: 10.1109/TMI.2020.2995508.
PubMed 32730212Metlay JP, Waterer GW. Treatment of Community-Acquired Pneumonia During the Coronavirus Disease 2019 (COVID-19) Pandemic. Ann Intern Med. 2020 Aug 18;173(4):304-305. doi: 10.7326/M20-2189. Epub 2020 May 7.
PubMed 32379883Wang Z, Xiao Y, Li Y, Zhang J, Lu F, Hou M, Liu X. Automatically discriminating and localizing COVID-19 from community-acquired pneumonia on chest X-rays. Pattern Recognit. 2021 Feb;110:107613. doi: 10.1016/j.patcog.2020.107613. Epub 2020 Aug 26.
PubMed 32868956Pernica JM, Harman S, Kam AJ, Carciumaru R, Vanniyasingam T, Crawford T, Dalgleish D, Khan S, Slinger RS, Fulford M, Main C, Smieja M, Thabane L, Loeb M. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.
PubMed 33683325Waseem MH, Lasi FF, Valecha J, Samejo B, Sangrasi SA, Ali SM. Effectiveness of Chest Physiotherapy in Cerebrovascular Accident Patients With Aspiration Pneumonia. Journal of Modern Rehabilitation. 2021;15(1):47-52.
Ryrso CK, Faurholt-Jepsen D, Ritz C, Pedersen BK, Hegelund MH, Dungu AM, Sejdic A, Lindegaard B, Krogh-Madsen R. The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial. Trials. 2021 Aug 28;22(1):571. doi: 10.1186/s13063-021-05503-2.
PubMed 34454594Nair GB, Niederman MS. Updates on community acquired pneumonia management in the ICU. Pharmacol Ther. 2021 Jan;217:107663. doi: 10.1016/j.pharmthera.2020.107663. Epub 2020 Aug 15.
PubMed 32805298Leemans G, Belmans D, Van Holsbeke C, Becker B, Vissers D, Ides K, Verhulst S, Van Hoorenbeeck K. The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance. Pediatr Pulmonol. 2020 Aug;55(8):1984-1992. doi: 10.1002/ppul.24784. Epub 2020 Apr 22.
PubMed 32320537
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons Effects of Postural Drainage and Positive Expiratory Pressure Technique in Community Acquired Pneumonia.
- ClinicalTrials.gov ID
- NCT05356494
- Acronym / sponsor ID
- REC/Lhr/22/0318 M Ahmad
- Conditions
- Community-acquired Pneumonia
- Keywords
- Pneumonia,, Postural Drainage, Positive Expiratory Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Community-acquired pneumonia is acquired outside the hospital. Postural drainage is the positioning of a patient with an involved lung segment such that gravity has a maximal effect of facilitating the drainage of Broncho-pulmonary secretions from the tracheobronchial tree. It is based on the concept of gravity-assisted mobilization of secretions and transports it for removal. The objective of the study to find the effect of postural drainage and positive expiratory pressure techniques (PEP) to improve the air way clearance and breathing in pneumonia patients. This study will be a RCT and will be conducted in Services Hospital. The study will be completed within the duration of six month. Consecutive sampling study technique will be used to collect the data. The sample size of 46 patients will be taken. Patients will be divided into two groups. (Group A will be treated with postural drainage and Group B will be treated with positive expiratory pressure technique). Outcome measure will be taken on Pulse oximeter, incentive spirometer and chest X- Ray. A regular follow up visits to department and a final assessment was made at the end of four week. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro- Wilk test, it will be decided either parametric or non-parametric test will be use within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study concluded that both techniques are effective in improving oxygen saturation and reported statistically significant differences, but no other parameter was statistically improved.
| Arm | Type | Receives |
|---|---|---|
| postural drainage | Experimental | Other: Postural drainage(Group A will be treated with postural drainage) |
| positive expiratory pressure technique | Experimental | Other: Positive expiratory pressure(Group B will be treated with positive expiratory pressure technique). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with community acquired pneumonia.
- Clinically stable patients.
- Both genders
- Age 30 to 70 years
Key exclusion criteria (4 listed)
- Presence of any genetic disorders (cystic fibrosis).
- Recent spinal / chest surgery
- Cardiac issues
- Fractures of vertebra caused by osteoporosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postural drainage(Group A will be treated with postural drainage) | Other | postural drainage |
| Positive expiratory pressure(Group B will be treated with positive expiratory pressure technique). | Other | positive expiratory pressure technique |
Primary outcome
INCENTIVE SPIROMETER
Time frame: 1 Last week
An incentive spirometer is a handheld device that helps your lungs recover after a surgery or lung illness. When you breathe from an incentive spirometer, a piston rises inside the device and measures the volume of your breath. A healthcare provider can set a target breath volume for you to hit.
OXYGEN SATURATION
Time frame: 1 Last week
Oxygen saturation, or "O2 sates," indicates that amount of oxygen traveling through your body with your red blood cells. Normal oxygen saturation is usually between 95% and 100% for most health.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 32191588Li L, Qin L, Xu Z, Yin Y, Wang X, Kong B, Bai J, Lu Y, Fang Z, Song Q, Cao K, Liu D, Wang G, Xu Q, Fang X, Zhang S, Xia J, Xia J. Using Artificial Intelligence to Detect COVID-19 and Community-acquired Pneumonia Based on Pulmonary CT: Evaluation of the Diagnostic Accuracy. Radiology. 2020 Aug;296(2):E65-E71. doi: 10.1148/radiol.2020200905. Epub 2020 Mar 19.
- Background: PubMed 32730212Ouyang X, Huo J, Xia L, Shan F, Liu J, Mo Z, Yan F, Ding Z, Yang Q, Song B, Shi F, Yuan H, Wei Y, Cao X, Gao Y, Wu D, Wang Q, Shen D. Dual-Sampling Attention Network for Diagnosis of COVID-19 From Community Acquired Pneumonia. IEEE Trans Med Imaging. 2020 Aug;39(8):2595-2605. doi: 10.1109/TMI.2020.2995508.
- Background: PubMed 32379883Metlay JP, Waterer GW. Treatment of Community-Acquired Pneumonia During the Coronavirus Disease 2019 (COVID-19) Pandemic. Ann Intern Med. 2020 Aug 18;173(4):304-305. doi: 10.7326/M20-2189. Epub 2020 May 7.
- Background: PubMed 32868956Wang Z, Xiao Y, Li Y, Zhang J, Lu F, Hou M, Liu X. Automatically discriminating and localizing COVID-19 from community-acquired pneumonia on chest X-rays. Pattern Recognit. 2021 Feb;110:107613. doi: 10.1016/j.patcog.2020.107613. Epub 2020 Aug 26.
- Background: PubMed 33683325Pernica JM, Harman S, Kam AJ, Carciumaru R, Vanniyasingam T, Crawford T, Dalgleish D, Khan S, Slinger RS, Fulford M, Main C, Smieja M, Thabane L, Loeb M. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.
- BackgroundWaseem MH, Lasi FF, Valecha J, Samejo B, Sangrasi SA, Ali SM. Effectiveness of Chest Physiotherapy in Cerebrovascular Accident Patients With Aspiration Pneumonia. Journal of Modern Rehabilitation. 2021;15(1):47-52.
- Background: PubMed 34454594Ryrso CK, Faurholt-Jepsen D, Ritz C, Pedersen BK, Hegelund MH, Dungu AM, Sejdic A, Lindegaard B, Krogh-Madsen R. The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial. Trials. 2021 Aug 28;22(1):571. doi: 10.1186/s13063-021-05503-2.
- Background: PubMed 32805298Nair GB, Niederman MS. Updates on community acquired pneumonia management in the ICU. Pharmacol Ther. 2021 Jan;217:107663. doi: 10.1016/j.pharmthera.2020.107663. Epub 2020 Aug 15.
- Background: PubMed 32320537Leemans G, Belmans D, Van Holsbeke C, Becker B, Vissers D, Ides K, Verhulst S, Van Hoorenbeeck K. The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance. Pediatr Pulmonol. 2020 Aug;55(8):1984-1992. doi: 10.1002/ppul.24784. Epub 2020 Apr 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sidra Faisal, MS.CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural drainage and Positive expiratory pressure in people with Community-acquired Pneumonia, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INCENTIVE SPIROMETER (time frame: 1 Last week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356494, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2022.