Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease
NCT ID: NCT06634485
Last Updated: 2024-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
64 participants
OBSERVATIONAL
2024-10-10
2026-12-20
Brief Summary
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* The secondary objective is to compare diaphragmatic function, Skeletal muscle mass, and spirometry results in patients with COPD.
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Detailed Description
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* 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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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control group
This group include healthy volunteers who aged ≥ 40 years .
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 midaxillary and anterior axillary lines at the eighth or ninth intercostal space.
3. Quadricep\|rectus femoris muscle assessment will be done by placing the transducer perpendicular to the long axis of the thigh.
* Spirometry:-will be performed thrice by experienced technicians at our pulmonary function laboratory. Patients will be asked to take a maximal inspiration and then to forcefully expel air for as long and as quickly as possible.
study group
This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks .
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 midaxillary and anterior axillary lines at the eighth or ninth intercostal space.
3. Quadricep\|rectus femoris muscle assessment will be done by placing the transducer perpendicular to the long axis of the thigh.
* Spirometry:-will be performed thrice by experienced technicians at our pulmonary function laboratory. Patients will be asked to take a maximal inspiration and then to forcefully expel air for as long and as quickly as possible.
Interventions
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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 midaxillary and anterior axillary lines at the eighth or ninth intercostal space.
3. Quadricep\|rectus femoris muscle assessment will be done by placing the transducer perpendicular to the long axis of the thigh.
* Spirometry:-will be performed thrice by experienced technicians at our pulmonary function laboratory. Patients will be asked to take a maximal inspiration and then to forcefully expel air for as long and as quickly as possible.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with disorders that may affect diaphragmatic function as
1. Musculoskeletal / neurological disorders
2. diaphragmatic eventration \\ hiatus hernia
3. morbid obesity
4. recent thoracic/abdominal surgeries
5. pregnancy; pleurodesis \\fibrothorax.
* Group B (study group):-
* Patients need for non- invasive ventilation.
* Patients with disorders that may affect diaphragmatic function as
1. Musculoskeletal / neurological disorders
2. diaphragmatic eventration \\ hiatus hernia
3. morbid obesity
4. recent thoracic/abdominal surgeries
5. pregnancy; pleurodesis \\fibrothorax
41 Years
70 Years
MALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Safaa Mohamed Shazly
Principal Investigator
Central Contacts
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References
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Winsey HS, Jones PF. Acute abdominal pain in childhood: analysis of a year's admissions. Br Med J. 1967 Mar 18;1(5541):653-5. doi: 10.1136/bmj.1.5541.653. No abstract available.
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Hodgkin JE. Preoperative evaluation of pulmonary function. Am J Surg. 1979 Sep;138(3):355-60. doi: 10.1016/0002-9610(79)90263-0.
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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.
Schroll K. [Surgical removal of the upper 3d molars]. ZWR. 1986 Jun;95(6):630, 633-4, 637-9. No abstract available. German.
Taylor MA, Briggs GS, Baker KC, Cummings NJ, Pratt KA, Freedman RB, Goodenough PW. Expression of the pro-regions of papain and papaya proteinase IV in Escherichia coli and their inhibition of mature cysteine proteinases. Biochem Soc Trans. 1995 Feb;23(1):80S. doi: 10.1042/bst023080s. No abstract available.
Taggart SC. The healthy city. J R Coll Physicians Lond. 1998 Nov-Dec;32(6):568-71. No abstract available.
Kanareikin KF, Kukuev LA. [Soviet neuropathology during World War II 1941-1945 ( on the 50th anniversary of the outbreak of World War II)]. Zh Nevropatol Psikhiatr Im S S Korsakova. 1991;91(6):99-102. No abstract available. Russian.
Lopez AD, Shibuya K, Rao C, Mathers CD, Hansell AL, Held LS, Schmid V, Buist S. Chronic obstructive pulmonary disease: current burden and future projections. Eur Respir J. 2006 Feb;27(2):397-412. doi: 10.1183/09031936.06.00025805. No abstract available.
Other Identifiers
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Ultrasound in COPD
Identifier Type: -
Identifier Source: org_study_id
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