Incentive Spirometry in Routine Management of COPD Patients

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT05679609
Collaborator
(none)
40
1
2
16
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: incentive spirometry
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Value of Incentive Spirometry in Routine Management of COPD Patients and Its Effect on Diaphragmatic Function
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: group 1

participants would use incentive spirometry for 2 months together with ordinary medical treatment

Device: incentive 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.

No Intervention: group 2

participants would receive only ordinary medical treatment for 2 months

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. change in arterial blood gases [2 months]

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

  7. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Amal A. El-Koa Cairo Egypt

Sponsors and Collaborators

  • Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Amal A. El-Koa, doctor, Menoufia University
ClinicalTrials.gov Identifier:
NCT05679609
Other Study ID Numbers:
  • 6/2022CHES4-1
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amal A. El-Koa, doctor, Menoufia University

Study Results

No Results Posted as of Jan 11, 2023