COPDNCT01821365
End Tidal Carbon Dioxide Monitoring for Evaluating Changes of PaCO2 After Noninvasive Mechanical Ventilation in COPD
An observational study of COPD, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect the level of PaCO2,but some investigators found that PETCO2 measurements did not reflect PaCO2 in COPD patients.There may be several… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Jul 2013
- How long will I take part?
- 2 Days
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a COPD exacerbation who admitted to the respiratory department of First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,China
Inclusion Criteria:1.patients are enrolled in accordance with 2011 international treatment guidelines of COPD.
2.patients are in a clear state of mind and can incompliance with clinicians to extend breathing only using nose and closing mouth.
Exclusion Criteria:1.Hemodynamic instability. 2.Pulmonary embolism,Pneumothorax, pleural effusion, upper airway obstruction,Chest trauma, chest wall deformities, neuromuscular diseases, lung tumor.
3.combinating acute exacerbation of bronchial asthma in this hospitalization. 4.Nose and mouth trauma, deformity, or recent surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Rongchang Chen, MD, 020-83062718, Chenrc99@163.com
Ting Jiang, MM
About this study
Official title: End Tidal Carbon Dioxide Monitoring for Evaluating Changes of Arterial Carbon Dioxide After Noninvasive Mechanical Ventilation in Chronic Obstructive Pulmonary Disease
Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect the level of PaCO2,but some investigators found that PETCO2 measurements did not reflect PaCO2 in COPD patients.There may be several reasons for this discrepancy. Due to airway obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to 5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.our study mainly focus on two issues.First, to explore the optimal depth of tube placed when patients with COPD breathe spontaneously or receive noninvasive ventilation, and compare the differences of two condition at the same time. Secondly, to evaluate the agreement between the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation when our extension tube locates in the optimal position, and investigate whether PETCO2（5s）can be used to monitor ventilation status dynamically.
Read the detailed description
Non-invasive positive pressure ventilation(NPPV) can significantly improve gas exchange and relieve respiratory muscle fatigue for COPD,and arterial blood gas is the gold standard to evaluate ventilation status,but the procedure is time consuming,invasive, painful and in some patients.
Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect the level of PaCO2, but for patients with COPD, due to the presence of airway obstruction and emphysema formation, which cause ventilation-perfusion ratio(V/Q) , result to dead space-tidal volume ratio(VD/VT) and right-to-left shunting(Qs/Qt), the time of various lung units discharge of carbon dioxide is not synchronous. Some investigators found that PETCO2 measurements did not reflect PaCO2 in COPD patients. There may be several reasons for this discrepancy. Due to airway obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to 5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.
our study mainly focus on two issues.First, to explore the optimal depth of tube placed when patients with COPD breathe spontaneously or receive noninvasive ventilation, and compare the differences of two condition at the same time. Secondly, to evaluate the agreement between the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation when our extension tube locates in the optimal position, and investigate whether PETCO2（5s）can be used to monitor ventilation status dynamically.
- Conditions
- COPD
- Keywords
- COPD,PETCO2,PaCO2
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
the agreement and correlation between the partial pressure of end-tidal carbon dioxide(PETCO2)
PETCO2 was measured by using sidestream capnometer though prolonged expiratory method(extend to 5s) , and obtained arterial blood sampling simultaneously.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ting Jiang, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821365
- Sponsor's protocol ID
- 2009CB522100
- Status last verified
- Apr 2013
- First submitted
- 27 Mar 2013
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu CH, Chou HC, Hsieh WS, Chen WK, Huang PY, Tsao PN. Good estimation of arterial carbon dioxide by end-tidal carbon dioxide monitoring in the neonatal intensive care unit. Pediatr Pulmonol. 2003 Apr;35(4):292-5. doi: 10.1002/ppul.10260.
PubMed 12629627Trevisanuto D, Giuliotto S, Cavallin F, Doglioni N, Toniazzo S, Zanardo V. End-tidal carbon dioxide monitoring in very low birth weight infants: correlation and agreement with arterial carbon dioxide. Pediatr Pulmonol. 2012 Apr;47(4):367-72. doi: 10.1002/ppul.21558. Epub 2011 Nov 18.
PubMed 22102598Tai CC, Lu FL, Chen PC, Jeng SF, Chou HC, Chen CY, Tsao PN, Hsieh WS. Noninvasive capnometry for end-tidal carbon dioxide monitoring via nasal cannula in nonintubated neonates. Pediatr Neonatol. 2010 Dec;51(6):330-5. doi: 10.1016/S1875-9572(10)60064-2.
PubMed 21146797McSwain SD, Hamel DS, Smith PB, Gentile MA, Srinivasan S, Meliones JN, Cheifetz IM. End-tidal and arterial carbon dioxide measurements correlate across all levels of physiologic dead space. Respir Care. 2010 Mar;55(3):288-93.
PubMed 20196877Lopez E, Grabar S, Barbier A, Krauss B, Jarreau PH, Moriette G. Detection of carbon dioxide thresholds using low-flow sidestream capnography in ventilated preterm infants. Intensive Care Med. 2009 Nov;35(11):1942-9. doi: 10.1007/s00134-009-1647-5.
PubMed 19760396Cinar O, Acar YA, Arziman I, Kilic E, Eyi YE, Ocal R. Can mainstream end-tidal carbon dioxide measurement accurately predict the arterial carbon dioxide level of patients with acute dyspnea in ED. Am J Emerg Med. 2012 Feb;30(2):358-61. doi: 10.1016/j.ajem.2010.12.014. Epub 2011 Jan 28.
PubMed 21277140Howe TA, Jaalam K, Ahmad R, Sheng CK, Nik Ab Rahman NH. The use of end-tidal capnography to monitor non-intubated patients presenting with acute exacerbation of asthma in the emergency department. J Emerg Med. 2011 Dec;41(6):581-9. doi: 10.1016/j.jemermed.2008.10.017. Epub 2009 Mar 9.
PubMed 19272745
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End Tidal Carbon Dioxide Monitoring for Evaluating Changes of Arterial Carbon Dioxide After Noninvasive Mechanical Ventilation in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01821365
- Acronym / sponsor ID
- 2009CB522100
- Conditions
- COPD
- Keywords
- COPD,PETCO2,PaCO2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 1 Apr 2013 (estimated)
- 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.
Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect the level of PaCO2,but some investigators found that PETCO2 measurements did not reflect PaCO2 in COPD patients.There may be several reasons for this discrepancy. Due to airway obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to 5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.our study mainly focus on two issues.First, to explore the optimal depth of tube placed when patients with COPD breathe spontaneously or receive noninvasive ventilation, and compare the differences of two condition at the same time. Secondly, to evaluate the agreement between the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation when our extension tube locates in the optimal position, and investigate whether PETCO2（5s）can be used to monitor ventilation status dynamically.
Detailed description
Non-invasive positive pressure ventilation(NPPV) can significantly improve gas exchange and relieve respiratory muscle fatigue for COPD,and arterial blood gas is the gold standard to evaluate ventilation status,but the procedure is time consuming,invasive, painful and in some patients.
Sidestream end-tidal CO2 has been found to be closely correlated to PaCO2 especially when people have the stable hemodynamics and normal lung function. PETCO2 can basically reflect the level of PaCO2, but for patients with COPD, due to the presence of airway obstruction and emphysema formation, which cause ventilation-perfusion ratio(V/Q) , result to dead space-tidal volume ratio(VD/VT) and right-to-left shunting(Qs/Qt), the time of various lung units discharge of carbon dioxide is not synchronous. Some investigators found that PETCO2 measurements did not reflect PaCO2 in COPD patients. There may be several reasons for this discrepancy. Due to airway obstruction and ventilation-perfusion mismatch, there is a delay in the maximum alveolar concentration of CO2 reaching the cannula, which may give lower PETCO2 values compared with PaCO2. To overcome this disadvantage, we tried to prolong their expiratory time (extend to 5-8s) in order to guarantee adequate time for alveolar CO2 reaching the cannula.
our study mainly focus on two issues.First, to explore the optimal depth of tube placed when patients with COPD breathe spontaneously or receive noninvasive ventilation, and compare the differences of two condition at the same time. Secondly, to evaluate the agreement between the PaCO2 and sidestream PETCO2（5s）values in COPD patients receiving noninvasive ventilation when our extension tube locates in the optimal position, and investigate whether PETCO2（5s）can be used to monitor ventilation status dynamically.
Study design
- Time perspective
- Prospective
- Target follow-up
- 2 Days
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a COPD exacerbation who admitted to the respiratory department of First Affiliated Hospital of Guangzhou Medical University,Guangzhou,Guangdong,China
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the agreement and correlation between the partial pressure of end-tidal carbon dioxide(PETCO2)
Time frame: one day
PETCO2 was measured by using sidestream capnometer though prolonged expiratory method(extend to 5s) , and obtained arterial blood sampling simultaneously.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- Background: PubMed 12629627Wu CH, Chou HC, Hsieh WS, Chen WK, Huang PY, Tsao PN. Good estimation of arterial carbon dioxide by end-tidal carbon dioxide monitoring in the neonatal intensive care unit. Pediatr Pulmonol. 2003 Apr;35(4):292-5. doi: 10.1002/ppul.10260.
- Results publication: PubMed 22102598Trevisanuto D, Giuliotto S, Cavallin F, Doglioni N, Toniazzo S, Zanardo V. End-tidal carbon dioxide monitoring in very low birth weight infants: correlation and agreement with arterial carbon dioxide. Pediatr Pulmonol. 2012 Apr;47(4):367-72. doi: 10.1002/ppul.21558. Epub 2011 Nov 18.
- Results publication: PubMed 21146797Tai CC, Lu FL, Chen PC, Jeng SF, Chou HC, Chen CY, Tsao PN, Hsieh WS. Noninvasive capnometry for end-tidal carbon dioxide monitoring via nasal cannula in nonintubated neonates. Pediatr Neonatol. 2010 Dec;51(6):330-5. doi: 10.1016/S1875-9572(10)60064-2.
- Results publication: PubMed 20196877McSwain SD, Hamel DS, Smith PB, Gentile MA, Srinivasan S, Meliones JN, Cheifetz IM. End-tidal and arterial carbon dioxide measurements correlate across all levels of physiologic dead space. Respir Care. 2010 Mar;55(3):288-93.
- Results publication: PubMed 19760396Lopez E, Grabar S, Barbier A, Krauss B, Jarreau PH, Moriette G. Detection of carbon dioxide thresholds using low-flow sidestream capnography in ventilated preterm infants. Intensive Care Med. 2009 Nov;35(11):1942-9. doi: 10.1007/s00134-009-1647-5.
- Results publication: PubMed 21277140Cinar O, Acar YA, Arziman I, Kilic E, Eyi YE, Ocal R. Can mainstream end-tidal carbon dioxide measurement accurately predict the arterial carbon dioxide level of patients with acute dyspnea in ED. Am J Emerg Med. 2012 Feb;30(2):358-61. doi: 10.1016/j.ajem.2010.12.014. Epub 2011 Jan 28.
- Results publication: PubMed 19272745Howe TA, Jaalam K, Ahmad R, Sheng CK, Nik Ab Rahman NH. The use of end-tidal capnography to monitor non-intubated patients presenting with acute exacerbation of asthma in the emergency department. J Emerg Med. 2011 Dec;41(6):581-9. doi: 10.1016/j.jemermed.2008.10.017. Epub 2009 Mar 9.
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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.
Rongchang Chen, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
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 COPD, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 5 Apr 2013. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rongchang Chen, MD (020-83062718, Chenrc99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the agreement and correlation between the partial pressure of end-tidal carbon dioxide(PETCO2) (time frame: one day). 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 NCT01821365, which also lists 7 linked publications.
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 5 Apr 2013.