Incentive Spirometry in Routine Management of COPD Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05679609
• Other study ID #: 6/2022CHES4-1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
Egypt	Amal A. El-Koa	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

AARC (American Association for Respiratory Care) clinical practice guideline. Incentive spirometry. Respir Care. 1991 Dec;36(12):1402-5. No abstract available. — View Citation

Barakat S, Michele G, George P, Nicole V, Guy A. Outpatient pulmonary rehabilitation in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2008;3(1):155-62. doi: 10.2147/copd.s2126. — View Citation

Casaburi R, Porszasz J, Burns MR, Carithers ER, Chang RS, Cooper CB. Physiologic benefits of exercise training in rehabilitation of patients with severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 May;155(5):1541-51. doi: 10.1164/ajrccm.155.5.9154855. — View Citation

Cheng YY, Lin SY, Hsu CY, Fu PK. Respiratory Muscle Training Can Improve Cognition, Lung Function, and Diaphragmatic Thickness Fraction in Male and Non-Obese Patients with Chronic Obstructive Pulmonary Disease: A Prospective Study. J Pers Med. 2022 Mar 16;12(3):475. doi: 10.3390/jpm12030475. — View Citation

Cortopassi F, Castro AA, Porto EF, Colucci M, Fonseca G, Torre-Bouscoulet L, Iamonti V, Jardim JR. Comprehensive exercise training improves ventilatory muscle function and reduces dyspnea perception in patients with COPD. Monaldi Arch Chest Dis. 2009 Sep;71(3):106-12. doi: 10.4081/monaldi.2009.355. — View Citation

Darnley GM, Gray AC, McClure SJ, Neary P, Petrie M, McMurray JJ, MacFarlane NG. Effects of resistive breathing on exercise capacity and diaphragm function in patients with ischaemic heart disease. Eur J Heart Fail. 1999 Aug;1(3):297-300. doi: 10.1016/s1388-9842(99)00027-6. — View Citation

GBD Chronic Respiratory Disease Collaborators. Prevalence and attributable health burden of chronic respiratory diseases, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Respir Med. 2020 Jun;8(6):585-596. doi: 10.1016/S2213-2600(20)30105-3. — View Citation

Petrovic M, Reiter M, Zipko H, Pohl W, Wanke T. Effects of inspiratory muscle training on dynamic hyperinflation in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:797-805. doi: 10.2147/COPD.S23784. Epub 2012 Nov 30. — View Citation

Scherer TA, Spengler CM, Owassapian D, Imhof E, Boutellier U. Respiratory muscle endurance training in chronic obstructive pulmonary disease: impact on exercise capacity, dyspnea, and quality of life. Am J Respir Crit Care Med. 2000 Nov;162(5):1709-14. doi: 10.1164/ajrccm.162.5.9912026. — View Citation

Stock MC, Downs JB, Gauer PK, Alster JM, Imrey PB. Prevention of postoperative pulmonary complications with CPAP, incentive spirometry, and conservative therapy. Chest. 1985 Feb;87(2):151-7. doi: 10.1378/chest.87.2.151. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessing the change in baseline diaphragmatic excursion in cm	assessing the change from Baseline diaphragmatic excursion (in cm) using ultrasound to 2 months	2 months
Primary	assessing the change in baseline percentage of diaphragmatic thickness fraction	assessing the change from baseline percentage of diaphragmatic thickness fraction (%) using ultrasound to 2 months	2 months
Primary	assessing the change in baseline forced vital capacity percentage of predicted	assessing the change from baseline forced vital capacity percentage of predicted (%) using spirometry to 2 months	2 months
Primary	assessing the change in baseline forced expiratory volume in 1st second/forced vital capacity percentage (%)	assessing the change from baseline forced expiratory volume in 1st second/forced vital capacity percentage (%) using spirometry to 2 months	2 months
Primary	assessing the change in baseline peak expiratory flow rate percentage	assessing the change from baseline peak expiratory flow rate percentage (%) using spirometry to 2 months	2 months
Primary	change in arterial blood gases	assessment the change in baseline PaO2 and PaCO2 (in mmHg) to 2 months	2 months
Primary	assessing the change in mMRC dysnea scale	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	2 months