Incentive Spirometry in Routine Management of COPD Patients

Not Applicable

Completed

• Conditions: COPD
• Interventions: Device: incentive spirometry

• Registration Number: NCT05679609
• Lead Sponsor: Menoufia University

Brief Summary

The incentive spirometer is a device that encourages patients, with visual and other positive feedback, to maximally inflate their lungs and sustain that inflation. However, its efficacy in patients with COPD has been little documented especially in diaphragmatic function. This study tried to assess the role of incentive spirometry on Spirometric functions, Sonographic diaphragmatic function, and the scale of dyspnea in COPD patients with exacerbation and with follow-up of these parameters after 2 months.

Detailed Description

Forty COPD patients were admitted with an acute exacerbation and the patients were divided randomly into 2 equal groups: the first used the incentive spirometer together with medical treatment (according to GOLD guidelines) for 2 months and the second received only medical treatment for 2 months. All participants, on admission, underwent assessment of mMRC dyspnea scale, spirometry, arterial blood gases, and diaphragmatic ultrasound. Then, a follow-up of the participants was done after 2 months with the same parameters and a comparison between both groups was done.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-07-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2023-01-11
• Last Update Posted: 2023-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• confirmed cases of COPD according to the criteria GOLD
• age more than 40 years

Exclusion Criteria

• bad acoustic window by ultrasound
• other chronic respiratory diseases
• lung malignancy
• recent major surgery
• inability to complete or perform the study
• patient refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	incentive spirometry	participants would use incentive spirometry for 2 months together with ordinary medical treatment

Primary Outcome Measures

Name	Time	Method
assessing the change in baseline percentage of diaphragmatic thickness fraction	2 months	assessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months
change in arterial blood gases	2 months	assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months
assessing the change in baseline diaphragmatic excursion in cm	2 months	assessing the change from Baseline diaphragmatic excursion (in cm) using ultrasound to 2 months
assessing the change in baseline peak expiratory flow rate percentage	2 months	assessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months
assessing the change in baseline forced vital capacity percentage of predicted	2 months	assessing the change from baseline forced vital capacity percentage of predicted (%) using spirometry to 2 months
assessing the change in baseline forced expiratory volume in 1st second/forced vital capacity percentage (%)	2 months	assessing the change from baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) using spirometry to 2 months
assessing the change in mMRC dysnea scale	2 months	assessing the change in the severity of dyspnea by mMRC dysnea scale from baseline to 2 months. It is 5 statements giving grades from 0 to 4 with the higher the degree, the more severe the shortness of breath in patients with COPD

Trial Locations

Locations (1)

Amal A. El-Koa; 🇪🇬 Cairo, Egypt