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Clinical Trials/NCT05679609
NCT05679609
Completed
Not Applicable

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

Menoufia University1 site in 1 country40 target enrollmentMarch 1, 2021
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Menoufia University
Enrollment
40
Locations
1
Primary Endpoint
assessing the change in baseline percentage of diaphragmatic thickness fraction
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
July 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amal A. El-Koa

doctor

Menoufia University

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

Outcomes

Primary Outcomes

assessing the change in baseline percentage of diaphragmatic thickness fraction

Time Frame: 2 months

assessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months

change in arterial blood gases

Time Frame: 2 months

assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months

assessing the change in baseline diaphragmatic excursion in cm

Time Frame: 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

Time Frame: 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

Time Frame: 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 (%)

Time Frame: 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

Time Frame: 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

Study Sites (1)

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