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.

Study Overview

• Status: Recruiting
• Conditions: Pneumothorax, Spontaneous
• Intervention / Treatment: Other: observational

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 Type: Observational
• Enrollment (Anticipated): 349

Contacts and Locations

• Study Contact: Name: Ka Pang Chan, MBChB; Phone Number: 35052211; Email: chankapang@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: David SC Hui, MD; Phone Number: 852 2632 3128; Email: dschui@cuhk.edu.hk
    • Contact: Ka Pang Chan, MBChB; Phone Number: 852 3505 3396; Email: chankapang@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with spontaneous, both primary and secondary, pneumothorax, excluding traumatic causes

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): September 30, 2025
• Study Completion (Anticipated): September 30, 2026

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Spontaneous pneumothorax
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax
• Other Study ID Numbers: PTX_outcomes_prospective

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No