Incentive Spirometry And Upper Abdominal Laparoscopic Surgery

Study Overview

Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

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.

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.

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

OTHER: Volume-oriented incentive spirometry
OTHER: Flow-oriented incentive spirometry

Muhammad Shakir Khan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-10-19
First Submitted that Met QC Criteria 2021-01-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-10-20
First Posted (ACTUAL) 2021-01-20	Results First Posted N/A	Last Verified 2021-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Volume-oriented incentive spirometry Postoperative Volume oriented incentive spirometry 3 times a day	OTHER: Volume-oriented incentive spirometry 3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days
EXPERIMENTAL: Flow-oriented incentive spirometry Postoperative Flow oriented incentive spirometry 3 times a day	OTHER: Flow-oriented incentive spirometry 3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Volume-oriented incentive spirometry

Postoperative Volume oriented incentive spirometry 3 times a day

OTHER: Volume-oriented incentive spirometry

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

EXPERIMENTAL: Flow-oriented incentive spirometry

Postoperative Flow oriented incentive spirometry 3 times a day

OTHER: Flow-oriented incentive spirometry

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

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
25 Years

Accepts Healthy Volunteers:

Patient with upper abdominal surgery (laparoscopy)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Abeer Fatima, MSPT-CPPT, Riphah International University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.
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.
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.

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