Cholecystitis Clinical Trial
Official title:
Compare the Effects of Volume-oriented Versus Flow-oriented Incentive Spirometry on Pulmonary Function and Functional Capacity in Patients of Upper Abdominal Laparoscopic Surgery
Verified date | October 2021 |
Source | Riphah International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 30, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | Inclusion Criteria: - Patient with upper abdominal surgery (laparoscopy) Exclusion Criteria: - Patients who had undergone open abdominal surgery and laparoscopic obstetrics and gynecological surgery. - Patients with unstable hemodynamic parameters (arterial pressure<100 mmHg systolic and <60 mmHg for diastolic and mean arterial Pressure (MAP) <80mmHg. - Patients with postoperative complications requiring mechanical ventilation. - Uncooperative patients or patients unable to understand or to use the device properly - Recent history of lower extremity fracture |
Country | Name | City | State |
---|---|---|---|
Pakistan | Railway General hospital | Rawalpindi | Punjab |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
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. — View Citation
do Nascimento Junior P, Módolo NS, Andrade S, Guimarães 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;(2):CD006058. doi: 10.1002/14651858.CD006058.pub3. Review. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Capacity | 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 | 2 days | |
Primary | Total Lung Capacity | 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. | 2 days | |
Primary | Forced vital capacity (FVC) | 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. | 2 days | |
Primary | Forced expiratory volume in 1 second (FEV1) | 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. | 2 days | |
Primary | FEV1/FVC ratio | FEEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80% | 2 days |
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