PneumothoraxNCT06276751
The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax
An observational study of Pneumothorax, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- End-tidal CO2 monitor
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 13 Feb 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent Şehir Hastanesi
Ankara, Çankaya, 06170
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumothorax
- Being tested
- End-tidal CO2 monitor
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-tidal CO2 monitorProcedure or surgery
Also called Measurement of end-tidal CO2 after tube thoracostomy application.
Throughout the study, measurements were taken at 2 and 4 hours after tube thoracostomy was applied to every patient undergoing the procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
ETCO2-0
It was defined as the end-tidal CO2 (ETCO2) measured at the emergency department visit.
Measured: Five minutes have passed since the emergency room application.
ΔETCO2-1
The change in ETCO2-1 compared to ETCO2-0.
Measured: Two hours after the emergency room application.
ΔETCO2-2
The change in ETCO2-2 compared to ETCO2-0.
Measured: Four hours after the emergency room application.
ETCO2-1
End-tidal CO2 measured 2 hours after emergency department admission.
Measured: Two hours after the emergency room application.
ETCO2-2
End-tidal CO2 measured 2 hours after emergency department admission.
Measured: Four hours after the emergency room application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start15 Aug 2023
- Primary completion6 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Dönmez, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276751
- Sponsor's protocol ID
- E1-23-3870 ptx endtidalco2
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not currently planned.
Publications
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.
PubMed 34234966
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of End-Tidal CO2 in Patients Diagnosed With Pneumothorax in the Emergency Department and Its Role in Predicting Patient Outcomes
- ClinicalTrials.gov ID
- NCT06276751
- Acronym / sponsor ID
- E1-23-3870 ptx endtidalco2
- Conditions
- Pneumothorax
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End-tidal CO2 monitorAlso: Measurement of end-tidal CO2 after tube thoracostomy application.Throughout the study, measurements were taken at 2 and 4 hours after tube thoracostomy was applied to every patient undergoing the procedure. | Procedure or surgery | – |
Primary outcome
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.
ΔETCO2-1
Time frame: Two hours after the emergency room application.
The change in ETCO2-1 compared to ETCO2-0.
ΔETCO2-2
Time frame: Four hours after the emergency room application.
The change in ETCO2-2 compared to ETCO2-0.
ETCO2-1
Time frame: Two hours after the emergency room application.
End-tidal CO2 measured 2 hours after emergency department admission.
ETCO2-2
Time frame: Four hours after the emergency room application.
End-tidal CO2 measured 2 hours after emergency department admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 34234966Lee 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.
- Individual participant dataSharing planned: Undecided. Not currently planned.
Related trials for Pneumothorax
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Not yet recruitingPhase 2/3
Stop Air Leak by Talc or Autologous Blood Patch Therapy
Pneumothorax Spontaneous Secondary
Active, not recruiting
Outpatient Management of Primary Spontaneous Pneumothorax: Pigtail Catheter With Unidirectional Valve vs. Exsufflation, Randomized Prospective Study
Pneumothorax Spontaneous Primary
Not yet recruitingObservational study
The Impact of Artificial Intelligence-Assisted X-ray Interpretation on Radiologists' Diagnostic Performance
Pneumothorax, Intestinal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumothorax, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ETCO2-0 (time frame: Five minutes have passed since the emergency room application.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06276751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.