Preterm InfantNCT03758313
Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants
An observational study of Preterm Infant, run by Tobias Werther at 1 site in Austria.
Trial summary
In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infant
- What is being tested?
- CO2 measurements
- How many people
- 27 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2018to 30 Sep 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mechanically Ventilated Preterm Infants
Who may be able to join
- Preterm infants with a current body weight between 1000 g and 3000 g who require intubation.
- Signed informed consent from parents or legal guardians.
- Expected to provide at least three measurements of paCO2 and detCO2.
Who cannot join
- Infants with known congenital anomalies of the heart and/or lung.
- Need for high frequency oscillation.
- Parents or legal guardians deny informed consent.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Pediatrics, Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Medical University of Vienna
Vienna, 1090
About this study
In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line and, secondly, it does not provide the clinicians with a continuous measurement. At present, two alternative pCO2 monitoring systems are available in the field of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both methods have disadvantages including potential technical errors as well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA). In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the problem of unreliable etCO2 values in the presence of tube leakage.
The aim of this study is to compare the agreement, precision and repeatability of the distal etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may vary among different centers, this study helps to determine which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm infants at our neonatal intensive care units.
Read the detailed description
Background: In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line and, secondly, it does not provide the clinicians with a continuous measurement. At present, two alternative pCO2 monitoring systems are available in the field of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both methods have disadvantages including potential technical errors as well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA). In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the problem of unreliable etCO2 values in the presence of tube leakage.
Several studies compared etCO2 and tcCO2 to paCO2, simultaneously. A comparison study of etCO2 and tcCO2 in a cohort of critically ill children did not reveal significant differences in the absence of severe pulmonary parenchymal disease. Tobias et al compared etCO2 and tcCO2 in a cohort of pediatric intensive care patients with respiratory failure and found tcCO2 measurements to be more accurate. In a cohort of ventilated newborns, tcCO2 monitoring was generally more precise than etCO2 during neonatal transport to monitor ventilation. In a more recent study restricted to a cohort of postsurgical neonates without lung disease, etCO2 underestimated paCO2 more than tcCO2 but provided greater precision over paCO2, however it was less accurate at smaller tidal volumes. These studies have in common that the adapter of the pCO2 analyzer was attached in-line and proximal to the endotracheal tube.
Aim of the study: The aim of this study is to compare the agreement, precision and repeatability of the distal etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may vary among different centers, this study helps to determine which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm infants at our neonatal intensive care units.
- Conditions
- Preterm Infant
- Being tested
- CO2 measurements
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 measurementsOther
Distal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Carbon Dioxide in Mechanically Ventilated Preterm Infants
partial pressure of carbon dioxide
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start1 Nov 2018
- Primary completion26 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobias Werther
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tobias Werther, Medical University of Vienna
- Investigators
- Tobias Werther, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758313
- Sponsor's protocol ID
- 1173/2018
- Status last verified
- Aug 2021
- First submitted
- 26 Nov 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.
PubMed 18272893Giannakopoulou C, Korakaki E, Manoura A, Bikouvarakis S, Papageorgiou M, Gourgiotis D, Hatzidaki E. Significance of hypocarbia in the development of periventricular leukomalacia in preterm infants. Pediatr Int. 2004 Jun;46(3):268-73. doi: 10.1111/j.1442-200x.2004.01886.x.
PubMed 15151541Erickson SJ, Grauaug A, Gurrin L, Swaminathan M. Hypocarbia in the ventilated preterm infant and its effect on intraventricular haemorrhage and bronchopulmonary dysplasia. J Paediatr Child Health. 2002 Dec;38(6):560-2. doi: 10.1046/j.1440-1754.2002.00041.x.
PubMed 12410866Tobias JD. Transcutaneous carbon dioxide monitoring in infants and children. Paediatr Anaesth. 2009 May;19(5):434-44. doi: 10.1111/j.1460-9592.2009.02930.x. Epub 2009 Feb 19.
PubMed 19236597Aliwalas LL, Noble L, Nesbitt K, Fallah S, Shah V, Shah PS. Agreement of carbon dioxide levels measured by arterial, transcutaneous and end tidal methods in preterm infants < or = 28 weeks gestation. J Perinatol. 2005 Jan;25(1):26-9. doi: 10.1038/sj.jp.7211202.
PubMed 15496874Molloy EJ, Deakins K. Are carbon dioxide detectors useful in neonates? Arch Dis Child Fetal Neonatal Ed. 2006 Jul;91(4):F295-8. doi: 10.1136/adc.2005.082008.
PubMed 16790735McDonald MJ, Montgomery VL, Cerrito PB, Parrish CJ, Boland KA, Sullivan JE. Comparison of end-tidal CO2 and Paco2 in children receiving mechanical ventilation. Pediatr Crit Care Med. 2002 Jul;3(3):244-249. doi: 10.1097/00130478-200207000-00008.
PubMed 12780964Schmalisch G. Current methodological and technical limitations of time and volumetric capnography in newborns. Biomed Eng Online. 2016 Aug 30;15(1):104. doi: 10.1186/s12938-016-0228-4.
PubMed 27576441Anderson CT, Breen PH. Carbon dioxide kinetics and capnography during critical care. Crit Care. 2000;4(4):207-15. doi: 10.1186/cc696. Epub 2000 Jul 12.
PubMed 11094503Wu 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 12629627Amuchou Singh S, Singhal N. Dose end-tidal carbon dioxide measurement correlate with arterial carbon dioxide in extremely low birth weight infants in the first week of life? Indian Pediatr. 2006 Jan;43(1):20-5.
PubMed 16465002Dargaville PA, Tingay DG. Lung protective ventilation in extremely preterm infants. J Paediatr Child Health. 2012 Sep;48(9):740-6. doi: 10.1111/j.1440-1754.2012.02532.x.
PubMed 22970667Keszler M, Nassabeh-Montazami S, Abubakar K. Evolution of tidal volume requirement during the first 3 weeks of life in infants <800 g ventilated with Volume Guarantee. Arch Dis Child Fetal Neonatal Ed. 2009 Jul;94(4):F279-82. doi: 10.1136/adc.2008.147157. Epub 2008 Dec 5.
PubMed 19060010Nassabeh-Montazami S, Abubakar KM, Keszler M. The impact of instrumental dead-space in volume-targeted ventilation of the extremely low birth weight (ELBW) infant. Pediatr Pulmonol. 2009 Feb;44(2):128-33. doi: 10.1002/ppul.20954.
PubMed 19061234Hagerty JJ, Kleinman ME, Zurakowski D, Lyons AC, Krauss B. Accuracy of a new low-flow sidestream capnography technology in newborns: a pilot study. J Perinatol. 2002 Apr-May;22(3):219-25. doi: 10.1038/sj.jp.7210672.
PubMed 11948385
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring of Partial Pressure of Carbon Dioxide in Mechanically Ventilated Preterm Infants
- ClinicalTrials.gov ID
- NCT03758313
- Acronym / sponsor ID
- 1173/2018
- Conditions
- Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tobias WertherUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 26 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Nov 2018 (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.
In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line and, secondly, it does not provide the clinicians with a continuous measurement. At present, two alternative pCO2 monitoring systems are available in the field of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both methods have disadvantages including potential technical errors as well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA). In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the problem of unreliable etCO2 values in the presence of tube leakage.
The aim of this study is to compare the agreement, precision and repeatability of the distal etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may vary among different centers, this study helps to determine which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm infants at our neonatal intensive care units.
Detailed description
Background: In mechanically ventilated preterm infants, the ability to monitor carbon dioxide partial pressure (pCO2) values is indispensable. The gold standard for pCO2 measurement is from an arterial blood sample (paCO2). This has two drawbacks: firstly, it requires an arterial line and, secondly, it does not provide the clinicians with a continuous measurement. At present, two alternative pCO2 monitoring systems are available in the field of neonatal intensive care medicine: end-tidal CO2 (etCO2) capnography and transcutaneous CO2 (tcCO2) measurements. Both methods have disadvantages including potential technical errors as well as pathologies that may reduce reliability as a surrogate for blood gas analysis (BGA). In particular, conventional side-stream etCO2 capnography underestimates pCO2 in presence of a tube leakage, which is a common occurrence in ventilated preterm infants where only tubes without cuff are used. Distal etCO2 (detCO2) by means of a double lumen endo-tracheal tube may solve the problem of unreliable etCO2 values in the presence of tube leakage.
Several studies compared etCO2 and tcCO2 to paCO2, simultaneously. A comparison study of etCO2 and tcCO2 in a cohort of critically ill children did not reveal significant differences in the absence of severe pulmonary parenchymal disease. Tobias et al compared etCO2 and tcCO2 in a cohort of pediatric intensive care patients with respiratory failure and found tcCO2 measurements to be more accurate. In a cohort of ventilated newborns, tcCO2 monitoring was generally more precise than etCO2 during neonatal transport to monitor ventilation. In a more recent study restricted to a cohort of postsurgical neonates without lung disease, etCO2 underestimated paCO2 more than tcCO2 but provided greater precision over paCO2, however it was less accurate at smaller tidal volumes. These studies have in common that the adapter of the pCO2 analyzer was attached in-line and proximal to the endotracheal tube.
Aim of the study: The aim of this study is to compare the agreement, precision and repeatability of the distal etCO2-measurement technique described by Kugelman et al. with respect to paCO2 and tcCO2 in mechanically ventilated preterm infants. Since ventilation strategies and pCO2 limits may vary among different centers, this study helps to determine which non-invasive CO2 monitoring system (detCO2 or tcO2) is more suitable in terms of applicability and reliability in preterm infants at our neonatal intensive care units.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mechanically Ventilated Preterm Infants
Key inclusion criteria (3 listed)
- Preterm infants with a current body weight between 1000 g and 3000 g who require intubation.
- Signed informed consent from parents or legal guardians.
- Expected to provide at least three measurements of paCO2 and detCO2.
Key exclusion criteria (3 listed)
- Infants with known congenital anomalies of the heart and/or lung.
- Need for high frequency oscillation.
- Parents or legal guardians deny informed consent.
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 |
|---|---|---|
| CO2 measurementsDistal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer. | Other | – |
Primary outcome
Carbon Dioxide in Mechanically Ventilated Preterm Infants
Time frame: 48 hours
partial pressure of carbon dioxide
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 17 Aug 2021.
- Background: PubMed 18272893Morley CJ, Davis PG, Doyle LW, Brion LP, Hascoet JM, Carlin JB; COIN Trial Investigators. Nasal CPAP or intubation at birth for very preterm infants. N Engl J Med. 2008 Feb 14;358(7):700-8. doi: 10.1056/NEJMoa072788.
- Background: PubMed 15151541Giannakopoulou C, Korakaki E, Manoura A, Bikouvarakis S, Papageorgiou M, Gourgiotis D, Hatzidaki E. Significance of hypocarbia in the development of periventricular leukomalacia in preterm infants. Pediatr Int. 2004 Jun;46(3):268-73. doi: 10.1111/j.1442-200x.2004.01886.x.
- Background: PubMed 12410866Erickson SJ, Grauaug A, Gurrin L, Swaminathan M. Hypocarbia in the ventilated preterm infant and its effect on intraventricular haemorrhage and bronchopulmonary dysplasia. J Paediatr Child Health. 2002 Dec;38(6):560-2. doi: 10.1046/j.1440-1754.2002.00041.x.
- Background: PubMed 19236597Tobias JD. Transcutaneous carbon dioxide monitoring in infants and children. Paediatr Anaesth. 2009 May;19(5):434-44. doi: 10.1111/j.1460-9592.2009.02930.x. Epub 2009 Feb 19.
- Background: PubMed 15496874Aliwalas LL, Noble L, Nesbitt K, Fallah S, Shah V, Shah PS. Agreement of carbon dioxide levels measured by arterial, transcutaneous and end tidal methods in preterm infants < or = 28 weeks gestation. J Perinatol. 2005 Jan;25(1):26-9. doi: 10.1038/sj.jp.7211202.
- Background: PubMed 16790735Molloy EJ, Deakins K. Are carbon dioxide detectors useful in neonates? Arch Dis Child Fetal Neonatal Ed. 2006 Jul;91(4):F295-8. doi: 10.1136/adc.2005.082008.
- Background: PubMed 12780964McDonald MJ, Montgomery VL, Cerrito PB, Parrish CJ, Boland KA, Sullivan JE. Comparison of end-tidal CO2 and Paco2 in children receiving mechanical ventilation. Pediatr Crit Care Med. 2002 Jul;3(3):244-249. doi: 10.1097/00130478-200207000-00008.
- Background: PubMed 27576441Schmalisch G. Current methodological and technical limitations of time and volumetric capnography in newborns. Biomed Eng Online. 2016 Aug 30;15(1):104. doi: 10.1186/s12938-016-0228-4.
- Background: PubMed 11094503Anderson CT, Breen PH. Carbon dioxide kinetics and capnography during critical care. Crit Care. 2000;4(4):207-15. doi: 10.1186/cc696. Epub 2000 Jul 12.
- 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.
- Background: PubMed 16465002Amuchou Singh S, Singhal N. Dose end-tidal carbon dioxide measurement correlate with arterial carbon dioxide in extremely low birth weight infants in the first week of life? Indian Pediatr. 2006 Jan;43(1):20-5.
- Background: PubMed 22970667Dargaville PA, Tingay DG. Lung protective ventilation in extremely preterm infants. J Paediatr Child Health. 2012 Sep;48(9):740-6. doi: 10.1111/j.1440-1754.2012.02532.x.
- Individual participant dataSharing planned: Undecided
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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.
Tobias Werther, PhD principal investigator
Medical University of Vienna
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 Preterm Infant, run by Tobias Werther at 1 site in Austria.
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 3 inclusion and 3 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 17 Aug 2021. 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 Austria. 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?
Carbon Dioxide in Mechanically Ventilated Preterm Infants (time frame: 48 hours). 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 NCT03758313, which also lists 47 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 17 Aug 2021.