Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease

Official title

Correlation Between Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease : Case Control Study

Overview

* The primary objective is to evaluate the use of diaphragmatic function and skeletal muscle mass by ultrasound as a tool to establish the diagnosis of COPD and assess the severity of the disease. * The secondary objective is to compare diaphragmatic function, Skeletal muscle mass, and spirometry results in patients with COPD.

Detailed description

* Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. According to the GOLD report, COPD is projected to be the third leading cause of death by 2020, and currently, it is the fourth . * COPD is characterized by worsening dyspnea during movement . COPD restricts various activities of daily living due to shortness of breath, leading to poor quality of life and increased mortality and morbidity . * COPD impairs the function of diaphragm which is the primary muscle of inspiration. Diaphragm provides 75% of the increase in lung volume during quiet inspiration . * Movement of diaphragm during breathing is called diaphragm mobility. Movement of diaphragm from end-expiration to full inspiration is known as diaphragm excursion. * Diaphragmatic mobility is lower in patients with COPD than in healthy individuals . Hence it is necessary to assess diaphragm function in inpatients and outpatients diagnosed with COPD during emergencies. * Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of COPD that predicts morbidity and mortality independently from the severity of lung function impairment as judged by forced expiratory volume in 1 s (FEV1).Even in non cachectic patients with COPD, quadriceps strength is typically reduced by up to 30% compared with healthy elderly participants. Quadriceps strength independently predicts increased health-care utilization and mortality in COPD. While CT and magnetic resonance imaging (MRI) of the quadriceps have been studied in COPD, ultrasound use to assess limb muscle size has recently emerged as a newer, comparable, and noninvasive modality . * Ultrasonography is a cost-effective, radiation-free, widely available, and real-time investigation.Many studies have proposed the possible use of ultrasonography to measure the diaphragmatic excursion . * Spirometry is a noninvasive, easy, and valid tool for COPD assessment. There are established criteria based on spirometry, according to which COPD can be classified as mild, moderate, severe, and very severe .

There is a limited data about the association between spirometry, diaphragmatic excursion and skeletal muscle mass in patients with chronic obstructive pulmonary disease and further studies are needed

Interventions

• Device ultrasound, spirometry
  Ultrasound assessment of 1. diaphragmatic excursion:-the probe will be angled medially ,cranially , and dorsally so that the ultrasound beam reaches the posterior third of the diaphragm, in B-mode.Then, then M-mode exploration line will be placed perpendicular to the diaphragmatic dome to obtain maximum excursion . 2. (Tdi) will be measured using a high-frequency linear probe (10 MHz) placed on (ZA).The probe will be angled perpendicular to the lateral chest wall and placed between the midaxill

Primary outcome measures

• to study the correlation between diaphragmatic excursion and FEV1 [Time frame: Day 1]

Secondary outcome measures (1)

• correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

• Group A (control group):

• This group include healthy volunteers who aged ≥ 40 years .
• Group B (study group):

• This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks .

Exclusion criteria

• Group A (control group):

• Patients with disorders that may affect diaphragmatic function as

• Musculoskeletal / neurological disorders
• diaphragmatic eventration \\ hiatus hernia
• morbid obesity
• recent thoracic/abdominal surgeries
• pregnancy; pleurodesis \\fibrothorax.
• Group B (study group):-

• Patients need for non- invasive ventilation.
• Patients with disorders that may affect diaphragmatic function as

• Musculoskeletal / neurological disorders
• diaphragmatic eventration \\ hiatus hernia
• morbid obesity
• recent thoracic/abdominal surgeries
• pregnancy; pleurodesis \\fibrothorax

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Maynard-Paquette AC, Poirier C, Chartrand-Lefebvre C, Dube BP. Ultrasound Evaluation of the Quadriceps Muscle Contractile Index in Patients with Stable Chronic Obstructive Pulmonary Disease: Relationships with Clinical Symptoms, Disease Severity and Diaphragm Contractility. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:79-88. doi: 10.2147/COPD.S222945. eCollection 2020. PMID 32021146
• Santana PV, Prina E, Albuquerque AL, Carvalho CR, Caruso P. Identifying decreased diaphragmatic mobility and diaphragm thickening in interstitial lung disease: the utility of ultrasound imaging. J Bras Pneumol. 2016 Apr;42(2):88-94. doi: 10.1590/S1806-37562015000000266. PMID 27167428
• Skaarup SH, Lokke A, Laursen CB. The Area method: a new method for ultrasound assessment of diaphragmatic movement. Crit Ultrasound J. 2018 Jun 27;10(1):15. doi: 10.1186/s13089-018-0092-5. PMID 29946769
• Nair A, Alaparthi GK, Krishnan S, Rai S, Anand R, Acharya V, Acharya P. Comparison of Diaphragmatic Stretch Technique and Manual Diaphragm Release Technique on Diaphragmatic Excursion in Chronic Obstructive Pulmonary Disease: A Randomized Crossover Trial. Pulm Med. 2019 Jan 3;2019:6364376. doi: 10.1155/2019/6364376. eCollection 2019. PMID 30719351
• Houston JG, Angus RM, Cowan MD, McMillan NC, Thomson NC. Ultrasound assessment of normal hemidiaphragmatic movement: relation to inspiratory volume. Thorax. 1994 May;49(5):500-3. doi: 10.1136/thx.49.5.500. PMID 8016774
• Ramachandran P, Devaraj U, Patrick B, Saxena D, Venkatnarayan K, Louis V, Krishnaswamy UM, D'souza GA. Ultrasonographic assessment of skeletal muscle mass and diaphragm function in patients with chronic obstructive pulmonary disease: A case-control study. Lung India. 2020 May-Jun;37(3):220-226. doi: 10.4103/lungindia.lungindia_103_19. PMID 32367843
• Rocha FR, Bruggemann AK, Francisco DS, Medeiros CS, Rosal D, Paulin E. Diaphragmatic mobility: relationship with lung function, respiratory muscle strength, dyspnea, and physical activity in daily life in patients with COPD. J Bras Pneumol. 2017 Jan-Feb;43(1):32-37. doi: 10.1590/S1806-37562016000000097. PMID 28380186
• El-Halaby H, Abdel-Hady H, Alsawah G, Abdelrahman A, El-Tahan H. Sonographic Evaluation of Diaphragmatic Excursion and Thickness in Healthy Infants and Children. J Ultrasound Med. 2016 Jan;35(1):167-75. doi: 10.7863/ultra.15.01082. Epub 2015 Dec 17. PMID 26679203

Identifiers

NCT: NCT06634485 · Ultrasound in COPD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗