Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Benign Pancreas Tumor; Perforated Duodenal Ulcer; Diaphragmatic Hernia; Splenic Infarction; Splenomegaly; Hiatal Hernia; Cholecystitis; Malignant Pancreatic Neoplasm; Choledocholithiasis
• Interventions: Other: Flow-oriented incentive spirometry; Other: Volume-oriented incentive spirometry

• Registration Number: NCT04716166
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-20
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flow-oriented incentive spirometry	Flow-oriented incentive spirometry	Postoperative Flow oriented incentive spirometry 3 times a day
Volume-oriented incentive spirometry	Volume-oriented incentive spirometry	Postoperative Volume oriented incentive spirometry 3 times a day

Primary Outcome Measures

Name	Time	Method
Forced vital capacity (FVC)	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.
FEV1/FVC ratio	2 days	FEEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80%
Total Lung Capacity	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.
Functional Capacity	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
Forced expiratory volume in 1 second (FEV1)	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.

Trial Locations

Locations (1)

Railway General hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan