Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05356494
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2022-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Drainage and PEP Technique in Community Acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015916', 'term': 'Drainage, Postural'}, {'id': 'D011175', 'term': 'Positive-Pressure Respiration'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The results of the study are in accordance with current study but for improvement in oxygen saturation. However, other variables of ABGs did not show significant improvement after both techniques in community acquired pneumonia patients. In contrast to previous study, the techniques are only effective for improving saturation in patients with community acquired pneumonia.\n\nsingle blinded study only participant blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study concluded that both techniques are effective in improving oxygen saturation and reported statistically significant differences, but no other parameter was statistically improved.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2022-04-28', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'INCENTIVE SPIROMETER', 'timeFrame': '1 Last week', 'description': '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.'}, {'measure': 'OXYGEN SATURATION', 'timeFrame': '1 Last week', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pneumonia,', 'Postural Drainage', 'Positive Expiratory Pressure'], 'conditions': ['Community-acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '32191588', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32730212', 'type': 'BACKGROUND', 'citation': 'Ouyang 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.'}, {'pmid': '32379883', 'type': 'BACKGROUND', 'citation': 'Metlay 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.'}, {'pmid': '32868956', 'type': 'BACKGROUND', 'citation': 'Wang 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.'}, {'pmid': '33683325', 'type': 'BACKGROUND', 'citation': 'Pernica 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.'}, {'type': 'BACKGROUND', 'citation': 'Waseem 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.'}, {'pmid': '34454594', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32805298', 'type': 'BACKGROUND', 'citation': 'Nair 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.'}, {'pmid': '32320537', 'type': 'BACKGROUND', 'citation': 'Leemans 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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with community acquired pneumonia.\n* Clinically stable patients.\n* Both genders\n* Age 30 to 70 years\n\nExclusion Criteria:\n\n* Presence of any genetic disorders (cystic fibrosis).\n* Recent spinal / chest surgery\n* Cardiac issues\n* Fractures of vertebra caused by osteoporosis.'}, 'identificationModule': {'nctId': 'NCT05356494', 'briefTitle': 'Postural Drainage and PEP Technique in Community Acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Comparisons Effects of Postural Drainage and Positive Expiratory Pressure Technique in Community Acquired Pneumonia.', 'orgStudyIdInfo': {'id': 'REC/Lhr/22/0318 M Ahmad'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'postural drainage', 'description': '(Group A will be treated with postural drainage)', 'interventionNames': ['Other: Postural drainage']}, {'type': 'EXPERIMENTAL', 'label': 'positive expiratory pressure technique', 'description': '(Group B will be treated with positive expiratory pressure technique).', 'interventionNames': ['Other: Positive expiratory pressure']}], 'interventions': [{'name': 'Postural drainage', 'type': 'OTHER', 'description': '(Group A will be treated with postural drainage)', 'armGroupLabels': ['postural drainage']}, {'name': 'Positive expiratory pressure', 'type': 'OTHER', 'description': '(Group B will be treated with positive expiratory pressure technique).', 'armGroupLabels': ['positive expiratory pressure technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Hospital, Lahore.', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Sidra Faisal, MS.CPPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}