The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax

February 22, 2024 updated by: Safa Dönmez, Ankara City Hospital Bilkent

The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax in the Emergency Department and Its Role in Predicting Patient Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the study, a GE brand patient monitor (GE Medical Systems Information Technologies, Germany) was used for vital parameters, and a Medtronic brand Capnostream 35 respiratory monitor device (Oridion Medical 1987 Ltd., Israel) was used for ETCO2 measurement. Patients' ETCO2 measurements were performed using a device that measures ETCO2 levels in breaths delivered through the mouth and nose (sidestream measurement). ETCO2 values were measured before tube thoracostomy placement and at 2 and 4 hours after placement. The diagnosis of pneumothorax was confirmed by chest X-ray. Tube thoracostomy was performed by chest surgeons or emergency physicians. Indications for tube thoracostomy were determined by chest surgery doctors.

Patients' age, gender, height, weight, vital signs, smoking history, pneumothorax causes, lateral and apex collapse amount (in mm), procedures performed, ETCO2 values before and after tube insertion at 2 and 4 hours, hemogram, biochemistry, and blood gas values were recorded on case report forms. Additionally, patients' lengths of stay were recorded using archive numbers through the hospital automation system.

On chest X-ray, a distance greater than 2 cm between the parietal and visceral pleura at the hilum level according to British guidelines or a distance greater than 3 cm from the apex according to American guidelines was defined as a large pneumothorax. Additionally, the percentage of PTX volume for patients was calculated using the Collins method. The PTX percentage was calculated using the formula "%Collins = '4.2 + 4.7(a + b + c)'", where 'a' is the maximum apical interpleural distance, 'b' is the interpleural distance at the midpoint of the upper half of the lung, and 'c' is the interpleural distance at the midpoint of the lower half of the lung.

Neutrophil Lymphocyte Ratio (NLR) and Platelet Lymphocyte Ratio (PLR) calculations were performed.

The initial ETCO2 (ETCO2-0) was defined as the ETCO2 measured at the emergency department visit. PaCO2 was defined as the partial pressure of carbon dioxide measured with the first blood gas analysis taken at the emergency department visit. After lung expansion, ETCO2 was defined as the average value of ETCO2 measured 2 to 4 hours after tube thoracotomy (ETCO2-1/ETCO2-2, respectively). The increase in ETCO2 after expansion was defined as the increase in ETCO2 after closed tube thoracotomy (ETCO2 increase after drainage = ETCO2 after tube thoracotomy - initial ETCO2). The change from ETCO2-0 to ETCO2-1 was determined as deltaETCO2-1 (ΔETCO2-1), and the change from ETCO2-0 to ETCO2-2 was determined as ΔETCO2-2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06170
        • Ankara Bilkent Şehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ETCO2-0
Time Frame: Five minutes have passed since the emergency room application.
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
Time Frame: Two hours after the emergency room application.
The change in ETCO2-1 compared to ETCO2-0.
Two hours after the emergency room application.
ΔETCO2-2
Time Frame: Four hours after the emergency room application.
The change in ETCO2-2 compared to ETCO2-0.
Four hours after the emergency room application.
ETCO2-1
Time Frame: Two hours after the emergency room application.
End-tidal CO2 measured 2 hours after emergency department admission.
Two hours after the emergency room application.
ETCO2-2
Time Frame: Four hours after the emergency room application.
End-tidal CO2 measured 2 hours after emergency department admission.
Four hours after the emergency room application.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E1-23-3870 ptx endtidalco2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not currently planned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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