Clinical trial NCT05679609: Incentive Spirometry in Routine Management of COPD Patients
Official title: Value of Incentive Spirometry in Routine Management of COPD Patients and Its Effect on Diaphragmatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
incentive spirometry
diaphragmatic ultrasound
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: assessing the change in baseline diaphragmatic excursion in cm
timeFrame: 2 months
measure: assessing the change in baseline percentage of diaphragmatic thickness fraction
timeFrame: 2 months
measure: assessing the change in baseline forced vital capacity percentage of predicted
timeFrame: 2 months
measure: assessing the change in baseline forced expiratory volume in 1st second/forced vital capacity percentage (%)
timeFrame: 2 months
measure: assessing the change in baseline peak expiratory flow rate percentage
timeFrame: 2 months
measure: change in arterial blood gases
timeFrame: 2 months
measure: assessing the change in mMRC dysnea scale
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Amal A. El-Koa
Study officials:
References:
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