Intubated Neonates That Require Conventional VentilationNCT01572272
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
An observational study of Intubated Neonates That Require Conventional Ventilation, run by Oridion at 3 sites in Israel.
Trial summary
Primary: The purpose of this study is to assess the clinical implications of continuous distal CO2 monitoring when used for clinical decisions Sub Study: Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to the Carinal VitaLine set that its sampling tubing is made of PEBAX… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intubated Neonates That Require Conventional Ventilation
- How many people
- 66 participants
- Where
- 3 sitesIsrael
- Study dates
- Aug 2012to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Intubated neonates that require conventional ventilation
Who may be able to join
- Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico) that their respiratory condition requires conventional ventilation.
- Obtaining signed Informed Consent Form by the parents or legal guardian
- Intubated neonates that are expected to provide at least 3 pairs of blood samples and ETCO2 measurements during ventilation period
Who cannot join
- Intubated neonates with single-lumen ETTs
- Neonates who are ventilated with HFV
- Any significant medical condition which, at the investigator's discretion, may interfere with the study.
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
Primary:
The purpose of this study is to assess the clinical implications of continuous distal CO2 monitoring when used for clinical decisions
Read more
Sub Study:
- Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying material).
Description of Study Design:
Patients will be randomized at the baseline evaluation visit into one of the following groups:
- Masked group: Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.
- Open group: Data derived from the Capnostream20p and displayed to the medical team. It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary.
- Keywords
- Distal Capnography, CO2, neonates, conventional ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open | Open group: Data derived from the Capnostream20p and displayed to the medical team. It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary. | |
| Masked | Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare between the open and the masked group in the following: the percentage of measurement points at the Safe range: 60>PaCO2>30, Normal range 45>PaCO2>35 and Adequate (permissive) range: 45-55.
Participants will be follwed throughout the duration of the ventilation. Estimated time: 14 days
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2015
- Study completionFeb 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 Intubated Neonates That Require Conventional VentilationStudies 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
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oridion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amir Kugelman, Prof., Principal investigator, Bnai Zion MC, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01572272
- Sponsor's protocol ID
- D007157
- Status last verified
- Nov 2016
- First submitted
- 25 Mar 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kugelman A, Golan A, Riskin A, Shoris I, Ronen M, Qumqam N, Bader D, Bromiker R. Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study. J Pediatr. 2016 Jan;168:56-61.e2. doi: 10.1016/j.jpeds.2015.09.051. Epub 2015 Oct 17.
PubMed 26490126
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation. A Randomized, Multi-Center Study
- ClinicalTrials.gov ID
- NCT01572272
- Acronym / sponsor ID
- D007157
- Keywords
- Distal Capnography, CO2, neonates, conventional ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- OridionIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Apr 2012 (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.
Primary:
The purpose of this study is to assess the clinical implications of continuous distal CO2 monitoring when used for clinical decisions
Sub Study:
- Evaluate the average life time (duration) of Standard Carinal VitaLine set in comparison to the Carinal VitaLine set that its sampling tubing is made of PEBAX (dehumidifying material).
Description of Study Design:
Patients will be randomized at the baseline evaluation visit into one of the following groups:
- Masked group: Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it.
- Open group: Data derived from the Capnostream20p and displayed to the medical team. It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open | – | –Open group: Data derived from the Capnostream20p and displayed to the medical team. It will allow the treating physician and the nursing team to review the real time data and make clinical decisions based upon it if felt necessary. |
| Masked | – | –Data derived from the Capnostream20p will be recorded; however the medical staff will be masked from it and hence will not use it. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Intubated neonates that require conventional ventilation
Key inclusion criteria (3 listed)
- Intubated neonates with double-lumen ETT (Uncuffed Tracheal Tube, Mallinckrodt Inc., Chih, Mexico) that their respiratory condition requires conventional ventilation.
- Obtaining signed Informed Consent Form by the parents or legal guardian
- Intubated neonates that are expected to provide at least 3 pairs of blood samples and ETCO2 measurements during ventilation period
Key exclusion criteria (3 listed)
- Intubated neonates with single-lumen ETTs
- Neonates who are ventilated with HFV
- Any significant medical condition which, at the investigator's discretion, may interfere with the study.
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
Compare between the open and the masked group in the following: the percentage of measurement points at the Safe range: 60>PaCO2>30, Normal range 45>PaCO2>35 and Adequate (permissive) range: 45-55.
Time frame: 2 weeks
Participants will be follwed throughout the duration of the ventilation. Estimated time: 14 days
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 2 Nov 2016.
- Derived from this study: PubMed 26490126Kugelman A, Golan A, Riskin A, Shoris I, Ronen M, Qumqam N, Bader D, Bromiker R. Impact of Continuous Capnography in Ventilated Neonates: A Randomized, Multicenter Study. J Pediatr. 2016 Jan;168:56-61.e2. doi: 10.1016/j.jpeds.2015.09.051. Epub 2015 Oct 17.
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.
Amir Kugelman, Prof. principal investigator
Bnai Zion MC, Haifa Israel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intubated Neonates That Require Conventional Ventilation, run by Oridion at 3 sites 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 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Compare between the open and the masked group in the following: the percentage of measurement points at the Safe range: 60>PaCO2>30, Normal range 45>PaCO2>35 and Adequate (permissive) range: 45-55. (time frame: 2 weeks). 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 NCT01572272, 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 2 Nov 2016.