Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-26 @ 10:28 PM
Study NCT ID:
NCT04716166
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2021-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D013159', 'term': 'Splenic Infarction'}, {'id': 'D013163', 'term': 'Splenomegaly'}, {'id': 'D042883', 'term': 'Choledocholithiasis'}, {'id': 'D006551', 'term': 'Hernia, Hiatal'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013158', 'term': 'Splenic Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D003137', 'term': 'Common Bile Duct Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-19', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Capacity', 'timeFrame': '2 days', 'description': 'The six-minute walk test (6MWT) is a submaximal exercise test for evaluating physical functional capacity. Six meter walk distance ranges from 400 to 700 meter in normal individuals'}, {'measure': 'Total Lung Capacity', 'timeFrame': '2 days', 'description': 'Changes from the baseline will be measured on daily basis. Pulmonary function test will be measured by using a digital spirometer. Spirometry assesses the integrated mechanical function of the lung, chest wall, respiratory muscles, and airways by measuring the total volume of air exhaled from a full lung total lung capacity \\[TLC\\] TLC has a normal value ranges from 80% to 120%, of the predicted ratio.'}, {'measure': 'Forced vital capacity (FVC)', 'timeFrame': '2 days', 'description': 'Changes from the baseline will be measured on daily basis. Pulmonary function test will be measured by using a digital spirometer. FVC is the total volume of air that can be exhaled during a maximally forced expiration effort. It ranges from 80% to 120% of the predicted value.'}, {'measure': 'Forced expiratory volume in 1 second (FEV1)', 'timeFrame': '2 days', 'description': 'FEV1 is the volume of air that can forcibly be blown out in the first 1 second, after full inspiration. Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value are considered normal.'}, {'measure': 'FEV1/FVC ratio', 'timeFrame': '2 days', 'description': 'FEEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Flow oriented incentive spirometry', 'Volume oriented incentive spirometry', 'Digital spirometer', 'Six minute walk test', 'Forced vital capacity (FVC)', 'Forced Expiratory Volume in the first second (FEV1)', 'Upper abdominal laparoscopy'], 'conditions': ['Cholecystitis', 'Perforated Duodenal Ulcer', 'Diaphragmatic Hernia', 'Benign Pancreas Tumor', 'Malignant Pancreatic Neoplasm', 'Splenic Infarction', 'Splenomegaly', 'Choledocholithiasis', 'Hiatal Hernia']}, 'referencesModule': {'references': [{'pmid': '27525116', 'type': 'BACKGROUND', 'citation': 'Alaparthi GK, Augustine AJ, Anand R, Mahale A. Comparison of Diaphragmatic Breathing Exercise, Volume and Flow Incentive Spirometry, on Diaphragm Excursion and Pulmonary Function in Patients Undergoing Laparoscopic Surgery: A Randomized Controlled Trial. Minim Invasive Surg. 2016;2016:1967532. doi: 10.1155/2016/1967532. Epub 2016 Jul 21.'}, {'pmid': '24510642', 'type': 'BACKGROUND', 'citation': 'do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.'}, {'pmid': '20551816', 'type': 'BACKGROUND', 'citation': 'Kundra P, Vitheeswaran M, Nagappa M, Sistla S. Effect of preoperative and postoperative incentive spirometry on lung functions after laparoscopic cholecystectomy. Surg Laparosc Endosc Percutan Tech. 2010 Jun;20(3):170-2. doi: 10.1097/SLE.0b013e3181db81ce.'}, {'pmid': '25721252', 'type': 'BACKGROUND', 'citation': 'Soares SM, Jannuzzi HP, Kassab MF, Nucci LB, Paschoal MA. Investigation of the immediate pre-operative physical capacity of patients scheduled for elective abdominal surgery using the 6-minute walk test. Physiotherapy. 2015 Sep;101(3):292-7. doi: 10.1016/j.physio.2014.11.004. Epub 2014 Dec 17.'}, {'pmid': '26894090', 'type': 'BACKGROUND', 'citation': 'Kumar AS, Alaparthi GK, Augustine AJ, Pazhyaottayil ZC, Ramakrishna A, Krishnakumar SK. Comparison of Flow and Volume Incentive Spirometry on Pulmonary Function and Exercise Tolerance in Open Abdominal Surgery: A Randomized Clinical Trial. J Clin Diagn Res. 2016 Jan;10(1):KC01-6. doi: 10.7860/JCDR/2016/16164.7064. Epub 2016 Jan 1.'}]}, 'descriptionModule': {'briefSummary': 'To compare the effects of volume-oriented versus flow-oriented incentive spirometry on pulmonary function tests and functional capacity in patients of upper abdominal laparoscopic surgery. Previous studies were designed to target only spirometer without focusing on its different types and their effects. This study covers the research gap and therefore is designed to observe effects of different types of spirometer on pulmonary function of patients undergoing upper abdominal laparoscopic surgery.', 'detailedDescription': 'The volume oriented incentive spirometer enables the patient to inhale air through a mouthpiece and corrugated tubing which is attached to a plastic bellows. The volume of air displaced is indicated on a scale located on the device enclosure. After the patient has achieved the maximum volume, the individual is instructed to hold this volume constant for 3 to 5 seconds.\n\nStudies suggest a physiologically significant difference in the effect of the flow- and volume-oriented incentive spirometer. Flow-oriented devices enforce more work of breathing and increase muscular activity of the upper chest. Volume-oriented devices enforce less work of breathing and improve diaphragmatic activity.\n\nResearch was carried out a study on two experimental groups of patients in order to evaluate the effects of aerobic exercise training and incentive spirometry in controlling pulmonary complications following laparoscopic cholecystectomy, results indicated a significant reduction in heart rate, Oxygen Saturation of hemoglobin (SaO2), and inspiratory capacity for both groups. The researchers concluded that aerobic exercise and incentive spirometry were beneficial in reducing the postoperative pulmonary complications after laparoscopic cholecystectomy.\n\nAnother study observed the comparative study on the effect of preoperative and postoperative incentive spirometry on the pulmonary function of fifty patients who had undergone laparoscopic cholecystectomy. The authors concluded that pulmonary function is well-preserved with preoperative than postoperative incentive spirometry.\n\nAnother study observed that the volume incentive spirometry resulted in early recovery of both pulmonary function and diaphragm movement in patients who undergone laparoscopic abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with upper abdominal surgery (laparoscopy)\n\nExclusion Criteria:\n\n* Patients who had undergone open abdominal surgery and laparoscopic obstetrics and gynecological surgery.\n* Patients with unstable hemodynamic parameters (arterial pressure\\<100 mmHg systolic and \\<60 mmHg for diastolic and mean arterial Pressure (MAP) \\<80mmHg.\n* Patients with postoperative complications requiring mechanical ventilation.\n* Uncooperative patients or patients unable to understand or to use the device properly\n* Recent history of lower extremity fracture'}, 'identificationModule': {'nctId': 'NCT04716166', 'briefTitle': 'Incentive Spirometry and Upper Abdominal Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Compare the Effects of Volume-oriented Versus Flow-oriented Incentive Spirometry on Pulmonary Function and Functional Capacity in Patients of Upper Abdominal Laparoscopic Surgery', 'orgStudyIdInfo': {'id': 'Muhammad Shakir Khan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volume-oriented incentive spirometry', 'description': 'Postoperative Volume oriented incentive spirometry 3 times a day', 'interventionNames': ['Other: Volume-oriented incentive spirometry']}, {'type': 'EXPERIMENTAL', 'label': 'Flow-oriented incentive spirometry', 'description': 'Postoperative Flow oriented incentive spirometry 3 times a day', 'interventionNames': ['Other: Flow-oriented incentive spirometry']}], 'interventions': [{'name': 'Volume-oriented incentive spirometry', 'type': 'OTHER', 'description': '3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days', 'armGroupLabels': ['Volume-oriented incentive spirometry']}, {'name': 'Flow-oriented incentive spirometry', 'type': 'OTHER', 'description': '3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days', 'armGroupLabels': ['Flow-oriented incentive spirometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Rawalpindi', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Railway General hospital', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}], 'overallOfficials': [{'name': 'Abeer Fatima, MSPT-CPPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}