Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

Pneumothorax, Spontaneous Clinical Trial

Official title:

Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397717
• Other study ID #: PTX_outcomes_prospective
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Ka Pang Chan, MBChB
• Phone: 35052211
• Email: chankapang[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 349
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumothorax
• Pneumothorax, Spontaneous

Intervention

Other:
• observational
Observational, without interfering the patient care of treating doctors

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	36 months
Secondary	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)	36 months
Secondary	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	36 months
Secondary	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	36 months