NCT05397717

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Oct 2022Sep 2026

First Submitted

Initial submission to the registry

May 23, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

May 23, 2022

Last Update Submit

February 24, 2023

Conditions

Pneumothorax, Spontaneous

Keywords

Spontaneous pneumothorax

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • To evaluate clinical characteristics and causes of pneumothorax

    36 months

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

    36 months

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

    36 months

Study Arms (1)

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

Interventions

observationalOTHER

Observational, without interfering the patient care of treating doctors

Spontaneous pneumothorax

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Pneumothorax

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Ka Pang Chan, MBChB

CONTACT

35052211chankapang@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 31, 2022

Study Start

October 1, 2022

Primary Completion

September 30, 2025

Study Completion (Estimated)

September 30, 2026

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)