Prospective Study on Clinical Outcomes of Spontaneous Pneumothorax

NCT ID: NCT05397717

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 349 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-09-30

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.

Conditions

Pneumothorax, Spontaneous

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

observational

Intervention Type: OTHER

Observational, without interfering the patient care of treating doctors

Interventions

observational

Observational, without interfering the patient care of treating doctors

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Ka Pang Chan

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Ka Pang Chan, MBChB

Role: CONTACT

chankapang@gmail.com

35052211

Facility Contacts

Ka Pang Chan, MBChB

Role: primary

chankapang@cuhk.edu.hk

852 3505 3396

David SC Hui, MD

Role: backup

dschui@cuhk.edu.hk

852 2632 3128

Other Identifiers

PTX_outcomes_prospective

Identifier Type: -

Identifier Source: org_study_id