HypoxiaNCT02704585
Comparison of Two Pulse Oximeters in Delivery Room
A study testing Nellcor and Masimo in people with Hypoxia, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices. Read more about this study
- Who is it for?
- Ages 1 minute to 15 minutesHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Nellcor and Masimo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- 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 15 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates in the operation or delivery room immediately after delivery whose parents agreed to enter the study
Who cannot join
- Malformation of one of the legs, not allowing sensor application. Any situation in which the study might interfere with the treatment of the newborn
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ruben Bromiker
Jerusalem, 91031
Ruben Bromiker, MD, 972508685154, bromi@smc.org.il
Yakir Shir, MD, 972523121040, yakirshir@gmail.com
About this study
Official title: Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study
Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.
Read the detailed description
After delivery babies will be located in the radiant warmer. The probe of each pulse oximeter will be applied to one of the feet. Both probes will be simultaneously connected to the female plug of the pulse oximeter.
Heart rate will be checked
Time to get a stable reading in each device (by observation on the devices' display) will be recorded; this will be the primary study outcome. Other vital signs (oxygen saturation, heart rate) and demographics) will be recorded as well.
Paired students T test will be used for the statistical analyzes.
- Conditions
- Hypoxia
- Being tested
- Nellcor, Masimo
- Keywords
- Neonatal resuscitation, Pulse oximetry
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NellcorDevice
Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter
MasimoDevice
Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter
| Study group | Role | What they receive |
|---|---|---|
| Nellcor | Other | Connection to Nellcor pulse oximeter for measuring oxygen saturation after birth Receives: Device: Nellcor |
| Masimo | Other | Connection to Masimo pulse oximeter for measuring oxygen saturation after birth Receives: Device: Masimo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to steady reading in the pulse oximeter
Measured: up to 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
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 HypoxiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bromiker, Ruben M.D, Shaare Zedek Medical Center
- Investigators
- Ruben Bromiker, MD, Study chair, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704585
- Sponsor's protocol ID
- 118/15
- Status last verified
- Mar 2016
- First submitted
- 24 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Baquero H, Alviz R, Castillo A, Neira F, Sola A. Avoiding hyperoxemia during neonatal resuscitation: time to response of different SpO2 monitors. Acta Paediatr. 2011 Apr;100(4):515-8. doi: 10.1111/j.1651-2227.2010.02097.x. Epub 2011 Jan 17.
PubMed 21091987
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Pulse Oximeters in Delivery Room: A Prospective Study
- ClinicalTrials.gov ID
- NCT02704585
- Acronym / sponsor ID
- 118/15
- Conditions
- Hypoxia
- Keywords
- Neonatal resuscitation, Pulse oximetry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 10 Mar 2016 (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.
Time to stable reading of oxygen saturation at the delivery room will be compared between two different devices.
Detailed description
After delivery babies will be located in the radiant warmer. The probe of each pulse oximeter will be applied to one of the feet. Both probes will be simultaneously connected to the female plug of the pulse oximeter.
Heart rate will be checked
Time to get a stable reading in each device (by observation on the devices' display) will be recorded; this will be the primary study outcome. Other vital signs (oxygen saturation, heart rate) and demographics) will be recorded as well.
Paired students T test will be used for the statistical analyzes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nellcor | Other | Device: NellcorConnection to Nellcor pulse oximeter for measuring oxygen saturation after birth |
| Masimo | Other | Device: MasimoConnection to Masimo pulse oximeter for measuring oxygen saturation after birth |
Who may qualify
- Ages
- 1 minute to 15 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates in the operation or delivery room immediately after delivery whose parents agreed to enter the study
Key exclusion criteria (1 listed)
- Malformation of one of the legs, not allowing sensor application. Any situation in which the study might interfere with the treatment of the newborn
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 |
|---|---|---|
| NellcorMeasurement of pulse oximetry in the delivery room with Nellcor pulse oximeter | Device | Nellcor |
| MasimoMeasurement of pulse oximetry in the delivery room with Masimo pulse oximeter | Device | Masimo |
Primary outcome
Time to steady reading in the pulse oximeter
Time frame: up to 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Results publication: PubMed 21091987Baquero H, Alviz R, Castillo A, Neira F, Sola A. Avoiding hyperoxemia during neonatal resuscitation: time to response of different SpO2 monitors. Acta Paediatr. 2011 Apr;100(4):515-8. doi: 10.1111/j.1651-2227.2010.02097.x. Epub 2011 Jan 17.
- Individual participant dataSharing planned: No
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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.
Ruben Bromiker, MD study chair
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nellcor and Masimo in people with Hypoxia, run by Shaare Zedek 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: status not confirmed, as of the sponsor's last update on 10 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yakir Shir, MD (972523121040, yakirshir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to steady reading in the pulse oximeter (time frame: up to 2 minutes). 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 NCT02704585, 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 10 Mar 2016.