NCT06276751

Brief Summary

Pneumothorax (PTX) is defined as the accumulation of air in the pleural space. PTX can cause a disruption in the perfusion of lung tissue in the affected area and increase intrathoracic pressure, potentially leading to obstruction of venous return and, consequently, posing a life-threatening condition. Therefore, PTX requiring urgent intervention is a significant concern in emergency departments. End-tidal carbon dioxide (ETCO2) provides insight into carbon dioxide levels resulting from lung perfusion and serves as a respiratory parameter informing the prognosis of various critical illnesses. One of the most important factors determining lung perfusion is the effective lung area. Among the crucial issues for emergency departments are PTX cases, which typically regress following urgent intervention, leading to the establishment of an effective lung area. Hypotheses have been proposed in the literature suggesting that ETCO2 may be affected in PTX cases due to the relationship between effective lung area and ETCO2. In this study, investigetors aimed to investigate changes in ETCO2 levels following tube thoracostomy applied to PTX cases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2024

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

February 15, 2024

Last Update Submit

February 22, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • ETCO2-0

    It was defined as the end-tidal CO2 (ETCO2) measured at the emergency department visit.

    Five minutes have passed since the emergency room application.

  • ΔETCO2-1

    The change in ETCO2-1 compared to ETCO2-0.

    Two hours after the emergency room application.

  • ΔETCO2-2

    The change in ETCO2-2 compared to ETCO2-0.

    Four hours after the emergency room application.

  • ETCO2-1

    End-tidal CO2 measured 2 hours after emergency department admission.

    Two hours after the emergency room application.

  • ETCO2-2

    End-tidal CO2 measured 2 hours after emergency department admission.

    Four hours after the emergency room application.

Interventions

Throughout the study, measurements were taken at 2 and 4 hours after tube thoracostomy was applied to every patient undergoing the procedure.

Also known as: Measurement of end-tidal CO2 after tube thoracostomy application.

Eligibility Criteria

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

The study included patients aged 18 and over, without any comorbidities, diagnosed with spontaneous or traumatic pneumothorax, who underwent tube thoracostomy, and had no other organ damage or injury.

You may qualify if:

  • Patients aged 18 and over
  • Individuals without comorbidities
  • Those diagnosed with spontaneous or traumatic pneumothorax
  • Patients who underwent tube thoracostomy
  • Individuals without other organ damage or injury

You may not qualify if:

  • Patients under 18 years of age or over 65 years of age
  • Patients who refuse to participate in the study
  • Pregnant women
  • Individuals diagnosed with acute/chronic lung disease
  • Those with a history of advanced heart failure
  • Individuals with advanced systemic disease
  • Patients with a history of malignancy (cancer)
  • Individuals with chronic liver disease
  • Those using sedative and analgesic neuro-psychiatric drugs
  • Patients with a history of psychological or neurological disorders
  • Individuals with acute organ damage or failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, 06170, Turkey (Türkiye)

Location

Related Publications (1)

  • Lee GM, Kim YW, Lee S, Do HH, Seo JS, Lee JH. End-Tidal Carbon Dioxide Monitoring for Spontaneous Pneumothorax. Emerg Med Int. 2021 Jun 14;2021:9976543. doi: 10.1155/2021/9976543. eCollection 2021.

    PMID: 34234966BACKGROUND

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 26, 2024

Study Start

August 15, 2023

Primary Completion

February 6, 2024

Study Completion

February 13, 2024

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations