Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04716166
• Other study ID #: Muhammad Shakir Khan
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: October 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Studies 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. Research 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. Another 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. Another 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Benign Pancreas Tumor
• Cholecystitis
• Choledocholithiasis
• Diaphragmatic Hernia
• Duodenal Ulcer
• Hernia
• Hernia, Diaphragmatic
• Hernia, Hiatal
• Hernias, Diaphragmatic, Congenital
• Hiatal Hernia
• Malignant Pancreatic Neoplasm
• Pancreatic Neoplasms
• Perforated Duodenal Ulcer
• Splenic Infarction
• Splenomegaly

Intervention

Other:
• Volume-oriented incentive spirometry
3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days
• Flow-oriented incentive spirometry
3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days

Locations

Country	Name	City	State
Pakistan	Railway General hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — 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

Outcome

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