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

NCT06115941 | Completed DMC

• 1 other identifier: 265
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholelithiasis; Epigastric Hernia; Duodenal Perforation

Keywords

Abdominal Surgery; Atelectasis; Incentive spirometry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Incentive spirometer group

EXPERIMENTAL

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

No Incentive spirometer group

NO INTERVENTION

In group B or "no incentive spirometry group" patients were not asked to perform incentive spirometry.

Interventions

Pre-Op Incentive Spirometer DEVICE

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.

Incentive spirometer group

Eligibility Criteria

• Age: 18 Years - 53 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Muhammad Naeem: lead

Study Sites (1)

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Cholelithiasis; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Department of Surgery

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 3, 2023
• Study Start: March 29, 2023
• Primary Completion: August 28, 2023
• Study Completion: September 28, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)