Using Pre-op Incentive Spirometer Reduces Chances of Basal Atelectasis in Patients Undergoing Upper Abdominal Surgeries

Using Pre-Operative Incentive Spirometer Reduces Chances of Basal Ateletasis in Patients Undergoing Upper Abdominal Surgeries- A Randomized Control Trial

ABSTRACT Objective: To compare frequency of basal atelectasis in patients undergoing upper abdominal surgery who are provided pre-operative incentive spirometry versus those not provided pre-operative incentive spirometry

Study Overview

• Status: Completed
• Conditions: Cholelithiasis; Epigastric Hernia; Duodenal Perforation
• Intervention / Treatment: Device: Pre-Op Incentive Spirometer

Detailed Description

After patient selection through "non-probability consecutive sampling" Investigator recorded baseline characteristics of our patients including age, gender and body mass index (BMI). Once recorded, patients will be randomly divided into two equal groups (each containing 37 patients). In group A or "incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file. In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.

After this, all the included patients underwent upper abdominal surgery by expert surgical team under general anesthesia. Type of surgery (Laparoscopic Cholecystectomy / Open Cholecystectomy / perforated duodenal repair/ Epigastric Hernia Repair / Gastrojejunostomy) and duration for which patient was on ventilator support (in minutes) was documented. After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung".

"The statistical package for social sciences (SPSS) version 22 software was used for statistical analysis of the data. Normality of test will be checked using Shapiro-Wilk test which showed that age and BMI were normally distributed while duration of ventilatory support was non-normal data. For qualitative variables frequency and percentages were used, whereas for quantitative data mean ± standard deviation and median (IQR) were used. Qualitative variables (gender, type of surgery and presence of basal atelectasis) were compared between groups with the use of chi-square test. Quantitative variable (age and BMI) were compared between groups using Student t-test while (duration of ventilatory support) were compared between groups using Mann-Whittney U-test. A p-value of ≤ 0.05 was considered significant".

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Pak Emirates Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age above 18 years
• Both gender
• ASA I and II
• Upper abdominal surgeries

Exclusion Criteria:

• Lower abdominal surgeries,
• ASA III-V status,
• Co-morbidities [like diabetes (HbA1C% ≥ 6.5% 11), hypertension
• Smoking
• Chronic lung condition (like asthma, chronic obstructive pulmonary disease, emphysema)
• Pulmonary tuberculosis
• Structural deformity of chest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Incentive spirometer group; incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file.	Device: Pre-Op Incentive Spirometer; incentive spirometry group" patients were directed to start incentive spirometry, 48 hours prior to surgery. They were given an incentive spirometer and were briefed that they should inhale into the mouth piece of spirometer to lift the balls to the roof of tube and hold for five seconds and then exhale. 13 They were asked to perform 10 such breaths for 6 times in a day till surgery under direct supervision of researcher and this was charted in patient file.
No Intervention: No Incentive spirometer group; In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased frequency in post operative Basal Atelectasis	After surgery, all the patients were given adequate analgesia and antibiotics as per standard hospital protocol. Patients were assessed at 48 hours after surgery for presence of basal atelectasis which will be diagnosed clinically by presence of new onset respiratory symptoms "cough, crackles, tachypnea and reduced breath sounds at bases" and by chest X-ray "presence of basal opacification, crowded air bronchograms, crowded pulmonary vasculature and compensatory hyper-expansion of surrounding unaffected lung	48 hours after surgery

Collaborators and Investigators

• Sponsor: Dr. Muhammad Naeem

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2023
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Incentive spirometry; Abdominal Surgery; Atelectasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No