Incentive Spirometry in Routine Management of COPD Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Value of Incentive Spirometry in Routine Management of COPD Patients and Its Effect on Diaphragmatic Function

Conditions
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COPD

Intervention / Treatment
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* Device: incentive spirometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>participants would use incentive spirometry for 2 months together with ordinary medical treatment | Device: incentive spirometry<br>* It is flow-oriented that has 3 chambers, (600, 900, and 1200 cc/s) and it has a mouthpiece and a ball in each chamber. After a quiet exhalation, each participant was instructed to take slow full inspirations and to keep as long as he can for at least 5 seconds, then he slowly expires. The device is used every hour at least 5 to 10 times in the session during wake time.<br>|
| No Intervention: group 2<br>participants would receive only ordinary medical treatment for 2 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing the change in baseline diaphragmatic excursion in cm | assessing the change from Baseline diaphragmatic excursion (in cm) using ultrasound to 2 months | 2 months | 
| assessing the change in baseline percentage of diaphragmatic thickness fraction | assessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months | 2 months | 
| assessing the change in baseline forced vital capacity percentage of predicted | assessing the change from baseline forced vital capacity percentage of predicted (%) using spirometry to 2 months | 2 months | 
| assessing the change in baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) | assessing the change from baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) using spirometry to 2 months | 2 months | 
| assessing the change in baseline peak expiratory flow rate percentage | assessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months | 2 months | 
| change in arterial blood gases | assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months | 2 months | 
| assessing the change in mMRC dysnea scale | 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 | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, incentive spirometry, diaphragmatic ultrasound