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Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05397717
Enrollment
349
Registered
2022-05-31
Start date
2022-10-01
Completion date
2026-09-30
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumothorax, Spontaneous

Keywords

Spontaneous pneumothorax

Brief 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. 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.

Interventions

OTHERobservational

Observational, without interfering the patient care of treating doctors

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital36 monthsTo evaluate the in-hospital mortality of spontaneous pneumothorax who admitted to the hospital

Secondary

MeasureTime frameDescription
To evaluate clinical characteristics and causes of pneumothorax36 monthswhich include symptomatology, radiographical changes and presence of underlying chronic lung disease (that help ot classify the type of pneumothorax)
To evaluate the risk factors and causes for in-hospital mortality of spontaneous pneumothorax36 monthswhich include age, body weight, extent of pneumothorax, number of pleural intervention and occurrence of complications
To evaluate other short and long-term outcomes due to pneumothorax36 monthswhich 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

Countries

Hong Kong

Contacts

Primary ContactKa Pang Chan, MBChB
chankapang@gmail.com35052211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026