COPDNCT06634485
Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease
An observational study of COPD and Ultrasound Therapy; Complications, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 41 to 70 years, men only
- Conditions the study is for
- COPD, Ultrasound Therapy; Complications
- What is being tested?
- ultrasound, spirometry
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 20 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Two groups will be enrolled in the study; the first group will include healthy volunteers who aged ≥ 40 years\& the second group will include stable COPD Patients of the same age group
Who may be able to join
- 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 .
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Correlation Between Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease : Case Control Study
- 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.
Read the 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
- Conditions
- COPD, Ultrasound Therapy; Complications
- Being tested
- ultrasound, spirometry
- Keywords
- COPD, Diaphragmatic Ultrasound, Spirometry, Skeletal Muscle Mass
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound, spirometryDevice
Ultrasound assessment of
- 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 .
- (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.
- 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 | Role | What they receive |
|---|---|---|
| control group | This group include healthy volunteers who aged ≥ 40 years . Receives: Device: ultrasound, spirometry | |
| study group | This include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks . Receives: Device: ultrasound, spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
to study the correlation between diaphragmatic excursion and FEV1
In the COPD group,The aim is to assess the correlation between diaphragmatic excursion and FEV1
Measured: Day 1
Secondary outcomes (1)
correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay
correlation between diaphragmatic excursion measured by thoracic ultrasound in cm , quadriceps muscle thickness measured by ultrasound in cm and duration of hospital stay (in days)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Mohamed Shazly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634485
- Sponsor's protocol ID
- Ultrasound in COPD
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 32021146Santana 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.
PubMed 27167428Skaarup 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.
PubMed 29946769Nair 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.
PubMed 30719351Houston 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.
PubMed 8016774Ramachandran 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.
PubMed 32367843Rocha 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.
PubMed 28380186El-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.
PubMed 26679203Antoniu SA. Descriptors of dyspnea in obstructive lung diseases. Multidiscip Respir Med. 2010 Jun 30;5(3):216-9. doi: 10.1186/2049-6958-5-3-216.
PubMed 22958466Qaiser M, Khan N, Jain A. Ultrasonographic Assessment of Diaphragmatic Excursion and its Correlation with Spirometry in Chronic Obstructive Pulmonary Disease Patients. Int J Appl Basic Med Res. 2020 Oct-Dec;10(4):256-259. doi: 10.4103/ijabmr.IJABMR_192_20. Epub 2020 Oct 7.
PubMed 33376699Kim T, Huh S, Chung JH, Kim YS, Yun RY, Park O, Lee SE. Clinical values of diaphragmatic movement in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2023 Jan 27;23(1):33. doi: 10.1186/s12890-022-02220-7.
PubMed 36703157Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
PubMed 17132052Lopez 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.
PubMed 16452599
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Spirometry ,diaphragmatic Ultrasound and Skeletal Muscle Mass in Patients with Chronic Obstructive Pulmonary Disease : Case Control Study
- ClinicalTrials.gov ID
- NCT06634485
- Acronym / sponsor ID
- Ultrasound in COPD
- Conditions
- COPD, Ultrasound Therapy; Complications
- Keywords
- COPD, Diaphragmatic Ultrasound, Spirometry, Skeletal Muscle Mass
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Device: ultrasound, spirometryThis group include healthy volunteers who aged ≥ 40 years . |
| study group | – | Device: ultrasound, spirometryThis include stable COPD Patients who will be diagnosed by GOLD 2024 and last excerbation ≥ 6weeks . |
Who may qualify
- Ages
- 41 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups will be enrolled in the study; the first group will include healthy volunteers who aged ≥ 40 years\& the second group will include stable COPD Patients of the same age group
Key inclusion criteria (4 listed)
- Group A (control group):
- Group B (study group):
Key exclusion criteria (15 listed)
- Group A (control group):
- Group B (study group):-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound, spirometryUltrasound 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. | Device | control group, study group |
Primary outcome
to study the correlation between diaphragmatic excursion and FEV1
Time frame: Day 1
In the COPD group,The aim is to assess the correlation between diaphragmatic excursion and FEV1
1 secondary outcome
correlation between diaphragmatic muscle function , skeletal muscle mass and duration of hospital stay
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Background: PubMed 32021146Maynard-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.
- Background: PubMed 27167428Santana 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.
- Background: PubMed 29946769Skaarup 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.
- Background: PubMed 30719351Nair 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.
- Background: PubMed 8016774Houston 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.
- Background: PubMed 32367843Ramachandran 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.
- Background: PubMed 28380186Rocha 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.
- Background: PubMed 26679203El-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.
- Background: PubMed 22958466Antoniu SA. Descriptors of dyspnea in obstructive lung diseases. Multidiscip Respir Med. 2010 Jun 30;5(3):216-9. doi: 10.1186/2049-6958-5-3-216.
- Background: PubMed 33376699Qaiser M, Khan N, Jain A. Ultrasonographic Assessment of Diaphragmatic Excursion and its Correlation with Spirometry in Chronic Obstructive Pulmonary Disease Patients. Int J Appl Basic Med Res. 2020 Oct-Dec;10(4):256-259. doi: 10.4103/ijabmr.IJABMR_192_20. Epub 2020 Oct 7.
- Background: PubMed 36703157Kim T, Huh S, Chung JH, Kim YS, Yun RY, Park O, Lee SE. Clinical values of diaphragmatic movement in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2023 Jan 27;23(1):33. doi: 10.1186/s12890-022-02220-7.
- Background: PubMed 17132052Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Ultrasound Therapy; Complications, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safaa Mohamed Shazly, resident doctor (01228942380, drsafaashazly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to study the correlation between diaphragmatic excursion and FEV1 (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06634485, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.