Spontaneous PneumothoraxNCT06644820
Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax
An observational study of Spontaneous Pneumothorax, run by Sohag University at 1 site in Egypt.
Trial summary
Pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. Spontaneous pneumothorax further classified as primary or secondary. Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spontaneous Pneumothorax
- What is being tested?
- radiology
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital
Who may be able to join
- The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital
Who cannot join
- Patients with traumatic or iatrogenic pneumothorax.
Trial locations and contacts
1 site in 1 country.
Mona T hussein, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag
Magdy M Amin, professor
About this study
Pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. Spontaneous pneumothorax further classified as primary or secondary. Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer,and interstitial lung diseases (ILDs) in older adults.
- Conditions
- Spontaneous Pneumothorax
- Being tested
- radiology
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiologyDiagnostic test
Chest x ray posteroanterior view and lateral view.
CT. chest without contrast:
To assess the underlying lung pathology e.g. multiple bullae, interstitial lung disease (ILD) , cavitating lesions or nodules.
| Study group | Role | What they receive |
|---|---|---|
| Primary spontaneous pneumothorax | Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. Receives: Diagnostic Test: radiology | |
| Secondary spontaneous pneumothorax | Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer, and interstitial lung diseases (ILDs) in older adults. Receives: Diagnostic Test: radiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
hospitalization time of patients with spontanous pneumothorax from addmission to discharge from hospital
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Oct 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spontaneous PneumothoraxStudies of the same condition, open and under way.
- More trials run by Sohag 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yassmin Mehana Aboelfadel, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644820
- Sponsor's protocol ID
- Soh-Med-24-09-14MS
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
PubMed 31613151Hilliard NJ, Marciniak SJ, Babar JL, Balan A. Evaluation of secondary spontaneous pneumothorax with multidetector CT. Clin Radiol. 2013 May;68(5):521-8. doi: 10.1016/j.crad.2012.10.008. Epub 2012 Dec 5.
PubMed 23218593Khusial RJ, Honkoop PJ, van der Meer V, Snoeck-Stroband JB, Sont JK. Validation of online Asthma Control Questionnaire and Asthma Quality of Life Questionnaire. ERJ Open Res. 2020 Jan 27;6(1):00289-2019. doi: 10.1183/23120541.00289-2019. eCollection 2020 Jan.
PubMed 32010723Noh TJ, Lee CH, Kang YA, Kwon SY, Yoon HI, Kim TJ, Lee KW, Lee JH, Lee CT. Chest computed tomography (CT) immediately after CT-guided transthoracic needle aspiration biopsy as a predictor of overt pneumothorax. Korean J Intern Med. 2009 Dec;24(4):343-9. doi: 10.3904/kjim.2009.24.4.343. Epub 2009 Nov 27.
PubMed 19949733
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT06644820
- Acronym / sponsor ID
- Soh-Med-24-09-14MS
- Conditions
- Spontaneous Pneumothorax
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 16 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.
Pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. Spontaneous pneumothorax further classified as primary or secondary. Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer,and interstitial lung diseases (ILDs) in older adults.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary spontaneous pneumothorax | – | Diagnostic Test: radiologyPrimary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. |
| Secondary spontaneous pneumothorax | – | Diagnostic Test: radiologySecondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer, and interstitial lung diseases (ILDs) in older adults. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital
Key inclusion criteria (1 listed)
- The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital
Key exclusion criteria (1 listed)
- Patients with traumatic or iatrogenic pneumothorax.
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 |
|---|---|---|
| radiologyChest x ray posteroanterior view and lateral view. CT. chest without contrast: To assess the underlying lung pathology e.g. multiple bullae, interstitial lung disease (ILD) , cavitating lesions or nodules. | Diagnostic test | Primary spontaneous pneumothorax, Secondary spontaneous pneumothorax |
Primary outcome
Duration of hospital stay
Time frame: 1 year
hospitalization time of patients with spontanous pneumothorax from addmission to discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Background: PubMed 31613151Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
- Background: PubMed 23218593Hilliard NJ, Marciniak SJ, Babar JL, Balan A. Evaluation of secondary spontaneous pneumothorax with multidetector CT. Clin Radiol. 2013 May;68(5):521-8. doi: 10.1016/j.crad.2012.10.008. Epub 2012 Dec 5.
- Background: PubMed 32010723Khusial RJ, Honkoop PJ, van der Meer V, Snoeck-Stroband JB, Sont JK. Validation of online Asthma Control Questionnaire and Asthma Quality of Life Questionnaire. ERJ Open Res. 2020 Jan 27;6(1):00289-2019. doi: 10.1183/23120541.00289-2019. eCollection 2020 Jan.
- Background: PubMed 19949733Noh TJ, Lee CH, Kang YA, Kwon SY, Yoon HI, Kim TJ, Lee KW, Lee JH, Lee CT. Chest computed tomography (CT) immediately after CT-guided transthoracic needle aspiration biopsy as a predictor of overt pneumothorax. Korean J Intern Med. 2009 Dec;24(4):343-9. doi: 10.3904/kjim.2009.24.4.343. Epub 2009 Nov 27.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mona T hussein, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Pneumothorax, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmin M Abo El Fadl, resident (01152340826, yasmine_mahany_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: 1 year). 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 NCT06644820, which also lists 4 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 16 Oct 2024.