Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634485
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Spirometry diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Correlation Between Spirometry diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease Case Control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 andor 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 FEV1Even 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 investigationMany 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
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 FEV1Even 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 investigationMany 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None