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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01821365
Other study ID # 2009CB522100
Secondary ID
Status Recruiting
Phase N/A
First received March 27, 2013
Last updated April 4, 2013
Start date March 2013
Est. completion date July 2013

Study information

Verified date April 2013
Source The First Affiliated Hospital of Guangzhou Medical University
Contact rongchang Chen, MD
Phone 020-83062718
Email Chenrc99@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 85 Years
Eligibility 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.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

Cinar 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 — View Citation

Howe 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 — View Citation

Lopez 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. — View Citation

McSwain 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. — View Citation

Tai 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. — View Citation

Trevisanuto 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/ — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one day No
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