New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempt… (NCT04089540) | Clinical Trial Compass
CompletedNot Applicable
New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
Austria16 participantsStarted 2016-10
Plain-language 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). 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
Who can participate
Age range
1 Minute – 4 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
* Fulfillment of indication for intubation
Exclusion Criteria:
\- Malformation of the upper respiratory tract
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.