Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

NCT04716166 | Completed DMC

• 1 other identifier: Muhammad Shakir Khan
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystitis; Perforated Duodenal Ulcer; Diaphragmatic Hernia; Benign Pancreas Tumor; Malignant Pancreatic Neoplasm; Splenic Infarction; Splenomegaly; Choledocholithiasis; Hiatal Hernia

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• FEV1/FVC ratio

  FEEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80%

  2 days

Study Arms (2)

Volume-oriented incentive spirometry

EXPERIMENTAL

Postoperative Volume oriented incentive spirometry 3 times a day

Other: Volume-oriented incentive spirometry

Flow-oriented incentive spirometry

EXPERIMENTAL

Postoperative Flow oriented incentive spirometry 3 times a day

Other: Flow-oriented incentive spirometry

Interventions

Volume-oriented incentive spirometry OTHER

3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days

Volume-oriented incentive spirometry

Flow-oriented incentive spirometry OTHER

3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days

Flow-oriented incentive spirometry

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with upper abdominal surgery (laparoscopy)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Railway General hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (5)

• 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: 27525116 BACKGROUND

• 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: 24510642 BACKGROUND

• 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: 20551816 BACKGROUND

• 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: 25721252 BACKGROUND

• 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.

  PMID: 26894090 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Hernia, Diaphragmatic; Pancreatic Neoplasms; Splenic Infarction; Splenomegaly; Choledocholithiasis; Hernia, Hiatal

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Splenic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Hypertrophy; Common Bile Duct Diseases; Bile Duct Diseases; Cholelithiasis

Study Officials

• Abeer Fatima, MSPT-CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 20, 2021
• Study Start: October 1, 2020
• Primary Completion: May 30, 2021
• Study Completion: May 30, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)