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NCT Number: NCT05397717

Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Observational, without interfering the patient care of treating doctors

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate clinical characteristics and causes of pneumothorax

    Time frame: 36 months

    which include symptomatology, radiographical changes and presence of underlying chronic lung disease (that help ot classify the type of pneumothorax)

  2. To evaluate the risk factors and causes for in-hospital mortality of spontaneous pneumothorax

    Time frame: 36 months

    which include age, body weight, extent of pneumothorax, number of pleural intervention and occurrence of complications

  3. To evaluate other short and long-term outcomes due to pneumothorax

    Time frame: 36 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Ka Pang Chan, MBChB

CONTACT

[email protected]

35052211

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 31, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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