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Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

Primary Purpose

Cholecystitis, Perforated Duodenal Ulcer, Diaphragmatic Hernia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Volume-oriented incentive spirometry
Flow-oriented incentive spirometry
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystitis focused on measuring 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

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Railway General hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Volume-oriented incentive spirometry

Flow-oriented incentive spirometry

Arm Description

Postoperative Volume oriented incentive spirometry 3 times a day

Postoperative Flow oriented incentive spirometry 3 times a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 19, 2021
Last Updated
October 19, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04716166
Brief Title
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volume-oriented incentive spirometry
Arm Type
Experimental
Arm Description
Postoperative Volume oriented incentive spirometry 3 times a day
Arm Title
Flow-oriented incentive spirometry
Arm Type
Experimental
Arm Description
Postoperative Flow oriented incentive spirometry 3 times a day
Intervention Type
Other
Intervention Name(s)
Volume-oriented incentive spirometry
Intervention Description
3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days
Intervention Type
Other
Intervention Name(s)
Flow-oriented incentive spirometry
Intervention Description
3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days
Primary Outcome Measure Information:
Title
Functional Capacity
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
Time Frame
2 days
Title
Total Lung Capacity
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.
Time Frame
2 days
Title
Forced vital capacity (FVC)
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.
Time Frame
2 days
Title
Forced expiratory volume in 1 second (FEV1)
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.
Time Frame
2 days
Title
FEV1/FVC ratio
Description
FEEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80%
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Fatima, MSPT-CPPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27525116
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.
Results Reference
background
PubMed Identifier
24510642
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.
Results Reference
background
PubMed Identifier
20551816
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.
Results Reference
background
PubMed Identifier
25721252
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.
Results Reference
background
PubMed Identifier
26894090
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.
Results Reference
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Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

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