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Incentive Spirometry in Routine Management of COPD Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05679609
Enrollment
40
Registered
2023-01-11
Start date
2021-03-01
Completion date
2022-07-01
Last updated
2023-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

COPD, incentive spirometry, diaphragmatic ultrasound

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.

Interventions

DEVICEincentive spirometry

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.

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
assessing the change in baseline diaphragmatic excursion in cm2 monthsassessing the change from Baseline diaphragmatic excursion (in cm) using ultrasound to 2 months
assessing the change in baseline percentage of diaphragmatic thickness fraction2 monthsassessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months
assessing the change in baseline forced vital capacity percentage of predicted2 monthsassessing 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 monthsassessing the change from baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) using spirometry to 2 months
assessing the change in baseline peak expiratory flow rate percentage2 monthsassessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months
change in arterial blood gases2 monthsassessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months
assessing the change in mMRC dysnea scale2 monthsassessing 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026