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CompletedNCT04716166Updated Oct 20, 2021

Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

An interventional study of Volume-oriented incentive spirometry and Flow-oriented incentive spirometry in Cholecystitis, Perforated Duodenal Ulcer and Diaphragmatic Hernia, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-20.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Oct 2020, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 60 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with upper abdominal surgery (laparoscopy)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Volume-oriented incentive spirometry

    Postoperative Volume oriented incentive spirometry 3 times a day

    Other: Volume-oriented incentive spirometry

  • Experimental
    Flow-oriented incentive spirometry

    Postoperative Flow oriented incentive spirometry 3 times a day

    Other: Flow-oriented incentive spirometry

Interventions

  • OtherVolume-oriented incentive spirometry

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

  • OtherFlow-oriented incentive spirometry

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 days

  2. 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.

    Time frame: 2 days

  3. 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.

    Time frame: 2 days

  4. 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.

    Time frame: 2 days

  5. FEV1/FVC ratio

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

    Time frame: 2 days

07

Study locations

1 site
  • Railway General hospital
    Rawalpindi, Punjab 46000, Pakistan
08

References and documents

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. PubMed 27525116 ↗
  • 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. PubMed 24510642 ↗
  • 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. PubMed 20551816 ↗
  • 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. PubMed 25721252 ↗
  • 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. PubMed 26894090 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04716166
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jan 20, 2021
Start date
Oct 1, 2020
Primary completion
May 30, 2021
Completion
May 30, 2021
Last update
Oct 20, 2021

Study contacts

Abeer Fatima, MSPT-CPPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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