Infants in NICU Ventilated With HFVNCT00859209
Capnography in Infants Ventilated With High Frequency Ventilation
An observational study of Infants in NICU Ventilated With HFV, run by Bnai Zion Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2). Read more about this study
- Who is it for?
- Ages 1 minute to 2 months
- Conditions the study is for
- Infants in NICU Ventilated With HFV
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2008to Apr 2015
- 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 1 minute to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants in NICU ventilated with HFV
Who may be able to join
- All intubated infants with double lumen ETT ventilated with HFV
Who cannot join
- Infants ventilated with single lumen ETT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capnography in Infants Ventilated With High Frequency Ventilation: Prospective, Observational, Multi-Center Study
The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2).
Read the detailed description
All infants with double lumen ETT on HFV are eligible.
- Conditions
- Infants in NICU Ventilated With HFV
- Keywords
- HVF, Premature infants, ETCO2
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigators primary outcome measure will be to evaluate the accuracy and the correlation of Microstream® dEtCO2 with the gold standard of PaCO2.
Measured: A Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2015
- Study completionApr 2015
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 Infants in NICU Ventilated With HFVStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Carmel Medical Center
- Responsible party
- Sponsor
- Investigators
- Kugelman Amir, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859209
- Sponsor's protocol ID
- 68/08
- Status last verified
- Mar 2009
- First submitted
- 10 Feb 2009
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kugelman A, Riskin A, Shoris I, Ronen M, Stein IS, Bader D. Continuous integrated distal capnography in infants ventilated with high frequency ventilation. Pediatr Pulmonol. 2012 Sep;47(9):876-83. doi: 10.1002/ppul.22524. Epub 2012 Feb 10.
PubMed 22328495
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capnography in Infants Ventilated With High Frequency Ventilation: Prospective, Observational, Multi-Center Study
- ClinicalTrials.gov ID
- NCT00859209
- Acronym / sponsor ID
- 68/08
- Conditions
- Infants in NICU Ventilated With HFV
- Keywords
- HVF, Premature infants, ETCO2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Carmel Medical Center
- Study start
- Dec 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Mar 2009 (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.
The investigators hypothesize that dEtCO2 measured by the Microstream® technique via a double-lumen ETT in infants ventilated with HFV would be feasible and adequately represent the arterial CO2 (PaCO2).
Detailed description
All infants with double lumen ETT on HFV are eligible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants in NICU ventilated with HFV
Key inclusion criteria (1 listed)
- All intubated infants with double lumen ETT ventilated with HFV
Key exclusion criteria (1 listed)
- Infants ventilated with single lumen ETT
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 investigators primary outcome measure will be to evaluate the accuracy and the correlation of Microstream® dEtCO2 with the gold standard of PaCO2.
Time frame: A Year
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 13 Aug 2015.
- Derived from this study: PubMed 22328495Kugelman A, Riskin A, Shoris I, Ronen M, Stein IS, Bader D. Continuous integrated distal capnography in infants ventilated with high frequency ventilation. Pediatr Pulmonol. 2012 Sep;47(9):876-83. doi: 10.1002/ppul.22524. Epub 2012 Feb 10.
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.
Kugelman Amir principal investigator
Bnai Zion Medical Center
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 Infants in NICU Ventilated With HFV, run by Bnai Zion Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 13 Aug 2015. 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 Israel. 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?
The investigators primary outcome measure will be to evaluate the accuracy and the correlation of Microstream® dEtCO2 with the gold standard of PaCO2. (time frame: A Year). 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 NCT00859209, 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 13 Aug 2015.