Pneumothorax, SpontaneousNCT05397717
Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax
An observational study of Pneumothorax, Spontaneous, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Pneumothorax can be fatal if treatment is delayed or the pneumothorax is refractory. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumothorax, Spontaneous
- What is being tested?
- observational
- Type of treatment
- Injection or infusion
- How many people
- 349 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2022to 30 Sep 2026
- 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: Patients with spontaneous, both primary and secondary, pneumothorax, excluding traumatic causes
Who may be able to join
- All patients with a confirmed diagnosis of spontaneous pneumothorax on admission or during the hospital stay
- Age greater than 18 years old
- Chinese ethnicity
- Able to sign written informed consent to participate in the study
Who cannot join
- Pneumothorax was not found by thoracic imaging
- Traumatic pneumothorax (including iatrogenic pneumothorax)
- Pneumothorax with recent (within one month) lung resection surgery, that may be due to staple line issues
- Trapped lung or non-expandable lungs, without evidence of air leakage
- Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Ka Pang Chan, MBChB, 852 3505 3396, chankapang@cuhk.edu.hk
David SC Hui, MD, 852 2632 3128, dschui@cuhk.edu.hk
About this study
Pneumothorax can be fatal if treatment is delayed or the pneumothorax is refractory. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. This study aims at evaluating the in-hospital mortality and relevant clinical outcomes of spontaneous pneumothorax and identifying their predictive factors. The data collected from this study will also guide the planning of subsequent research to overcome the knowledge and service gap in managing spontaneous pneumothorax.
Read the detailed description
Pneumothorax is a common respiratory disease and potentially recurrent, especially among patients with pre-existing lung diseases. It frequently requires in-patient care due to the need for invasive therapeutic procedures.
Pneumothorax can be fatal if treatment is delayed or the pneumothorax is refractory. The in-hospital mortality rate of spontaneous pneumothorax ranges between 0.7% and 15%, which is dependent on age, mode of admission and presence of co-existing lung diseases. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. A multicentre retrospective study in Hong Kong evaluating patients admitted for pneumothorax in the year 2004 reported a mortality rate of 0.6% in those who had failed drainage with intercostal tube drainage. However, this study was not powered to investigate the overall mortality rate of pneumothorax and its predictive factor.
The majority of patients with pneumothorax can be discharged after the resolution of pneumothorax. However, a significant proportion of them may experience prolonged stay in the hospital due to various complications secondary to pneumothorax, including subcutaneous emphysema, persistent air leakage, and hospital-acquired pneumonia. All these conditions may cast negative impact on the overall prognosis, burden of pleural intervention and length of stay. Again, the incidence rate and determining factors of these conditions are seldomly reported.
This study aims at evaluating the in-hospital mortality and relevant clinical outcomes of spontaneous pneumothorax and identifying their predictive factors. The data collected from this study will also guide the planning of subsequent research to overcome the knowledge and service gap in managing spontaneous pneumothorax.
- Conditions
- Pneumothorax, Spontaneous
- Being tested
- observational
- Keywords
- Spontaneous pneumothorax
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
Observational, without interfering the patient care of treating doctors
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous pneumothorax | A. Inclusion criteria i. All patients with a confirmed diagnosis of spontaneous pneumothorax on admission or during the hospital stay ii. Age greater than 18 years old iii. Chinese ethnicity iv. Able to sign written informed consent to participate in the study B. Exclusion criteria i. Pneumothorax was not found by thoracic imaging ii. Traumatic pneumothorax (including iatrogenic pneumothorax) iii. Pneumothorax with recent (within one month) lung resection surgery, that may be due to staple line issues iv. Trapped lung or non-expandable lungs, without evidence of air leakage v. Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital
To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital
Measured: 36 months
Secondary outcomes (3)
To evaluate clinical characteristics and causes of pneumothorax
which include symptomatology, radiographical changes and presence of underlying chronic lung disease (that help ot classify the type of pneumothorax)
Measured: 36 months
To evaluate the risk factors and causes for in-hospital mortality of spontaneous pneumothorax
which include age, body weight, extent of pneumothorax, number of pleural intervention and occurrence of complications
Measured: 36 months
To evaluate other short and long-term outcomes due to pneumothorax
which include Occurrence of respiratory and non-respiratory complications secondary to pneumothorax, 30-day and 90-day mortality rates, length of hospital stay, readmission and recurrence rates
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax, SpontaneousStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 349 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ka Pang Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397717
- Sponsor's protocol ID
- PTX_outcomes_prospective
- Status last verified
- Feb 2023
- First submitted
- 23 May 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax
- ClinicalTrials.gov ID
- NCT05397717
- Acronym / sponsor ID
- PTX_outcomes_prospective
- Conditions
- Pneumothorax, Spontaneous
- Keywords
- Spontaneous pneumothorax
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 349 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 31 May 2022 (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 can be fatal if treatment is delayed or the pneumothorax is refractory. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. This study aims at evaluating the in-hospital mortality and relevant clinical outcomes of spontaneous pneumothorax and identifying their predictive factors. The data collected from this study will also guide the planning of subsequent research to overcome the knowledge and service gap in managing spontaneous pneumothorax.
Detailed description
Pneumothorax is a common respiratory disease and potentially recurrent, especially among patients with pre-existing lung diseases. It frequently requires in-patient care due to the need for invasive therapeutic procedures.
Pneumothorax can be fatal if treatment is delayed or the pneumothorax is refractory. The in-hospital mortality rate of spontaneous pneumothorax ranges between 0.7% and 15%, which is dependent on age, mode of admission and presence of co-existing lung diseases. However, the mortality rates and their risk factors were mainly reported from retrospective studies, and local data regarding the mortality of spontaneous pneumothorax is scarce. A multicentre retrospective study in Hong Kong evaluating patients admitted for pneumothorax in the year 2004 reported a mortality rate of 0.6% in those who had failed drainage with intercostal tube drainage. However, this study was not powered to investigate the overall mortality rate of pneumothorax and its predictive factor.
The majority of patients with pneumothorax can be discharged after the resolution of pneumothorax. However, a significant proportion of them may experience prolonged stay in the hospital due to various complications secondary to pneumothorax, including subcutaneous emphysema, persistent air leakage, and hospital-acquired pneumonia. All these conditions may cast negative impact on the overall prognosis, burden of pleural intervention and length of stay. Again, the incidence rate and determining factors of these conditions are seldomly reported.
This study aims at evaluating the in-hospital mortality and relevant clinical outcomes of spontaneous pneumothorax and identifying their predictive factors. The data collected from this study will also guide the planning of subsequent research to overcome the knowledge and service gap in managing spontaneous pneumothorax.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous pneumothorax | – | Other: observationalA. Inclusion criteria i. All patients with a confirmed diagnosis of spontaneous pneumothorax on admission or during the hospital stay ii. Age greater than 18 years old iii. Chinese ethnicity iv. Able to sign written informed consent to participate in the study B. Exclusion criteria i. Pneumothorax was not found by thoracic imaging ii. Traumatic pneumothorax (including iatrogenic pneumothorax) iii. Pneumothorax with recent (within one month) lung resection surgery, that may be due to staple line issues iv. Trapped lung or non-expandable lungs, without evidence of air leakage v. Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spontaneous, both primary and secondary, pneumothorax, excluding traumatic causes
Key inclusion criteria (4 listed)
- All patients with a confirmed diagnosis of spontaneous pneumothorax on admission or during the hospital stay
- Age greater than 18 years old
- Chinese ethnicity
- Able to sign written informed consent to participate in the study
Key exclusion criteria (5 listed)
- Pneumothorax was not found by thoracic imaging
- Traumatic pneumothorax (including iatrogenic pneumothorax)
- Pneumothorax with recent (within one month) lung resection surgery, that may be due to staple line issues
- Trapped lung or non-expandable lungs, without evidence of air leakage
- Patients with psychiatric disease or cognitive impairment that may limit their ability of understanding or giving consent to the study
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 |
|---|---|---|
| observationalObservational, without interfering the patient care of treating doctors | Other | Spontaneous pneumothorax |
Primary outcome
To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital
Time frame: 36 months
To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital
3 secondary outcomes
To evaluate clinical characteristics and causes of pneumothorax
Time frame: 36 months
To evaluate the risk factors and causes for in-hospital mortality of spontaneous pneumothorax
Time frame: 36 months
To evaluate other short and long-term outcomes due to pneumothorax
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- 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. This study is not recruiting at the moment.
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 Pneumothorax, Spontaneous, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 5 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 28 Feb 2023. 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 Hong Kong. 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 Ka Pang Chan, MBChB (35052211, chankapang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2023.