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NCT Number: NCT04716166

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.

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Key information

Conditions

Cholecystitis Benign Pancreas Tumor Bile Duct Diseases Biliary Tract Diseases Cardiovascular Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Diaphragmatic Hernia Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gallbladder Diseases Hemic and Lymphatic Diseases Hernia Hernia, Diaphragmatic Hernia, Hiatal Hiatal Hernia Hypertrophy Infarction Internal Hernia Ischemia Lymphatic Diseases Malignant Pancreatic Neoplasm Necrosis Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perforated Duodenal Ulcer Splenic Diseases Splenic Infarction Splenomegaly Vascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Railway General hospital

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volume-oriented incentive spirometry

Other

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

Flow-oriented incentive spirometry

Other

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

Primary outcomes

  1. Functional Capacity

    Time frame: 2 days

    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. Total Lung Capacity

    Time frame: 2 days

    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.

  3. Forced vital capacity (FVC)

    Time frame: 2 days

    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.

  4. Forced expiratory volume in 1 second (FEV1)

    Time frame: 2 days

    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.

  5. FEV1/FVC ratio

    Time frame: 2 days

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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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