Intubation; Difficult or FailedNOONANCT04089540
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
A study testing New intubation method and Conventional intubation method in people with Intubation; Difficult or Failed and Preterm Infant, run by Medical University of Graz at 1 site in Austria.
Trial summary
This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). Read more about this study
- Who is it for?
- Ages 1 minute to 4 months
- Conditions the study is for
- Intubation; Difficult or Failed, Preterm Infant, Term Infant
- What is being tested?
- New intubation method and Conventional intubation method
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2016to Mar 2021
- 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 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
- Fulfillment of indication for intubation
Who cannot join
- Malformation of the upper respiratory tract
Trial locations and contacts
1 site in 1 country.
Austria1 site
Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz
Graz, 8036
About this study
Official title: New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study
This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation.
Hypothesis
- The new intubation method is safe
- The new intubation method leads to a reduction in the number of intubation attempts
- The new intubation method leads to a reduction of desaturations and bradycardia during intubation
- In the long term, it could lead to a reduction in morbidity and mortality
- Conditions
- Intubation; Difficult or Failed, Preterm Infant, Term Infant
- Being tested
- New intubation method, Conventional intubation method
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New intubation methodProcedure or surgery
Conventional intubation methodProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study group: New intubation method | Experimental | In the new intubation method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). Therefore an oxygen flow is already administered via the tube during the intubation process. Receives: Procedure: New intubation method |
| Control group: Conventional intubation | Other | In the control group the respirator is connected to the tube and ventilation is started after the insertion of the tube into the trachea. Therefore there is no oxygen flow administered during the intubation process. Receives: Procedure: Conventional intubation method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of intubation attempts
Changes in the number of intubation attempts
Measured: During intubation process
Secondary outcomes (6)
Duration of intubation process in minutes
Changes in duration
Measured: During intubation process
Number of desaturations
The number of desaturations below 80% SpO2
The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.
Measured: During intubation process
Total amount of time of desaturations
The total amount of time in seconds a patient spends below 80% SpO2.
The number of bradycardia below 100 beats per minute (bpm), as well as the total amount of time a patient spends less than 100 bpm.
Measured: During intubation process
Cerebral tissue oxygenation
Using near-infrared spectroscopy to monitor changes of the cerebral tissue oxygenation
Measured: 5 minutes before intubation start till 10 minutes after successful intubation
Morbidity
Changes in morbidity
Measured: up to 2 years
Mortality
Changes in mortality
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study startOct 2016
- Primary completionJan 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Morris, MD, Principal investigator, Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089540
- Sponsor's protocol ID
- NOONA
- Acronym
- NOONA
- Status last verified
- Mar 2021
- First submitted
- 5 Sep 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study
- ClinicalTrials.gov ID
- NCT04089540
- Acronym / sponsor ID
- NOONA / NOONA
- Conditions
- Intubation; Difficult or Failed, Preterm Infant, Term Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 13 Sep 2019 (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.
This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation.
Hypothesis
- The new intubation method is safe
- The new intubation method leads to a reduction in the number of intubation attempts
- The new intubation method leads to a reduction of desaturations and bradycardia during intubation
- In the long term, it could lead to a reduction in morbidity and mortality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group: New intubation method | Experimental | Procedure: New intubation methodIn the new intubation method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). Therefore an oxygen flow is already administered via the tube during the intubation process. |
| Control group: Conventional intubation | Other | Procedure: Conventional intubation methodIn the control group the respirator is connected to the tube and ventilation is started after the insertion of the tube into the trachea. Therefore there is no oxygen flow administered during the intubation process. |
Who may qualify
- Ages
- 1 minute to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
- Fulfillment of indication for intubation
Key exclusion criteria (1 listed)
- Malformation of the upper respiratory tract
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 |
|---|---|---|
| New intubation method | Procedure or surgery | Study group: New intubation method |
| Conventional intubation method | Procedure or surgery | Control group: Conventional intubation |
Primary outcome
Number of intubation attempts
Time frame: During intubation process
Changes in the number of intubation attempts
6 secondary outcomes
Duration of intubation process in minutes
Time frame: During intubation process
Number of desaturations
Time frame: During intubation process
Total amount of time of desaturations
Time frame: During intubation process
Cerebral tissue oxygenation
Time frame: 5 minutes before intubation start till 10 minutes after successful intubation
Morbidity
Time frame: up to 2 years
Mortality
Time frame: up to 2 years
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 16 Mar 2021.
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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.
Nicholas Morris, MD principal investigator
Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New intubation method and Conventional intubation method in people with Intubation; Difficult or Failed and Preterm Infant, run by Medical University of Graz 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 2 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 16 Mar 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?
Number of intubation attempts (time frame: During intubation process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2021.