Skip to main content
OpenTrials
Completed

NCT Number: NCT05679609

Incentive Spirometry in Routine Management of COPD Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amal A. El-Koa

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Incentive spirometry

Device

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. change in arterial blood gases

    Time frame: 2 months

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

  7. 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

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 11, 2023
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.