Neonatal DiseaseNCT06263790
Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
A study testing Intubating laryngeal mask and Direct laryngoscopy in people with Neonatal Disease and Intubation; Difficult or Failed, run by University Hospital Padova.
Trial summary
The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disease, Intubation; Difficult or Failed
- What is being tested?
- Intubating laryngeal mask and Direct laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2024
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Level III NICU consultants and residents will be eligible to participate in the study
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.
Read the detailed description
Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Furthermore, the procedure times are often longer than recommended by international guidelines, and repeated intubation attempts are associated with adverse events in unstable neonates.
Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale).
- Conditions
- Neonatal Disease, Intubation; Difficult or Failed
- Being tested
- Intubating laryngeal mask, Direct laryngoscopy
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubating laryngeal maskDevice
Intubation through a laryngeal mask
Direct laryngoscopyDevice
Intubation by using a direct laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Intubation via laryngeal mask | Experimental | Participants will be required to position the endotracheal tube in the manikin via a laryngeal mask Receives: Device: Intubating laryngeal mask |
| Intubation via direct laryngoscope | Active comparator | Participants will be required to position the endotracheal tube in the manikin via direct laryngoscopy Receives: Device: Direct laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success at the first attempt
The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer.
Measured: 3 minutes after the initiation of the procedure
Secondary outcomes (2)
Time of device positioning
Time of device positioning will be calculated as the sum of the time of device positioning in all attempts, as the procedure will be repeated in case of incorrect positioning
Measured: 3 minutes after the initiation of the procedure
Participant's opinion on difficulty of the procedure
Participants will report their opinion on insertion difficulty and overall difficulty using a Likert scale (1= not difficult, 5=very difficult)
Measured: 5 minutes after end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263790
- Sponsor's protocol ID
- NEOUNIPD1(2024)
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
PubMed 33773829Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029.
PubMed 15870667Sawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med. 2017;10(2):125-131. doi: 10.3233/NPM-171686.
PubMed 28409758Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010 Jun;57(6):588-601. doi: 10.1007/s12630-010-9272-x. Epub 2010 Jan 29.
PubMed 20112078Sauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study. J Pediatr. 2016 Oct;177:108-113. doi: 10.1016/j.jpeds.2016.06.051. Epub 2016 Jul 26.
PubMed 27470688Monfredini C, Cavallin F, Ouedraogo P, Ezzahraoui L, Pasta E, Trevisanuto D, Villani PE. Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial. Ital J Pediatr. 2025 Jun 20;51(1):196. doi: 10.1186/s13052-025-01988-8.
PubMed 40542416
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intubating Laryngeal Mask vs Direct Laryngoscopy: a Crossover Randomized Controlled Preterm Manikin Trial
- ClinicalTrials.gov ID
- NCT06263790
- Acronym / sponsor ID
- NEOUNIPD1(2024)
- Conditions
- Neonatal Disease, Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 16 Feb 2024 (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.
The study aims to compare the success and time of intubation through an intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn.
Detailed description
Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Furthermore, the procedure times are often longer than recommended by international guidelines, and repeated intubation attempts are associated with adverse events in unstable neonates.
Objectives: To compare success and time of intubation through intubating laryngeal mask vs. direct laryngoscopy in a manikin simulating a term infant. In addition, we will assess the operator's opinion on the procedure.
Methods: This is an unblinded, randomized, controlled, crossover (AB/BA) pilot trial of intubation procedure through intubating laryngeal mask vs direct laryngoscopy in a manikin simulating a term newborn. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure was the intubation success rate at the first attempt. Secondary outcome measures were the total time needed for the endotracheal tube positioning (calculated as the sum of the time of device positioning in all attempts), and the participant's opinion on using the device (evaluated using a Likert scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intubation via laryngeal mask | Experimental | Device: Intubating laryngeal maskParticipants will be required to position the endotracheal tube in the manikin via a laryngeal mask |
| Intubation via direct laryngoscope | Active comparator | Device: Direct laryngoscopyParticipants will be required to position the endotracheal tube in the manikin via direct laryngoscopy |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Level III NICU consultants and residents will be eligible to participate in the study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Intubating laryngeal maskIntubation through a laryngeal mask | Device | Intubation via laryngeal mask |
| Direct laryngoscopyIntubation by using a direct laryngoscope | Device | Intubation via direct laryngoscope |
Primary outcome
Success at the first attempt
Time frame: 3 minutes after the initiation of the procedure
The success of the first attempt will be defined as the achievement of the correct positioning of the endotracheal tube in the trachea as assessed by the external observer.
2 secondary outcomes
Time of device positioning
Time frame: 3 minutes after the initiation of the procedure
Participant's opinion on difficulty of the procedure
Time frame: 5 minutes after end of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Background: PubMed 33773829Madar J, Roehr CC, Ainsworth S, Ersdal H, Morley C, Rudiger M, Skare C, Szczapa T, Te Pas A, Trevisanuto D, Urlesberger B, Wilkinson D, Wyllie JP. European Resuscitation Council Guidelines 2021: Newborn resuscitation and support of transition of infants at birth. Resuscitation. 2021 Apr;161:291-326. doi: 10.1016/j.resuscitation.2021.02.014. Epub 2021 Mar 24.
- Background: PubMed 15870667Leone TA, Rich W, Finer NN. Neonatal intubation: success of pediatric trainees. J Pediatr. 2005 May;146(5):638-41. doi: 10.1016/j.jpeds.2005.01.029.
- Background: PubMed 28409758Sawyer T, Foglia E, Hatch LD, Moussa A, Ades A, Johnston L, Nishisaki A. Improving neonatal intubation safety: A journey of a thousand miles. J Neonatal Perinatal Med. 2017;10(2):125-131. doi: 10.3233/NPM-171686.
- Background: PubMed 20112078Gerstein NS, Braude DA, Hung O, Sanders JC, Murphy MF. The Fastrach Intubating Laryngeal Mask Airway: an overview and update. Can J Anaesth. 2010 Jun;57(6):588-601. doi: 10.1007/s12630-010-9272-x. Epub 2010 Jan 29.
- Background: PubMed 27470688Sauer CW, Kong JY, Vaucher YE, Finer N, Proudfoot JA, Boutin MA, Leone TA. Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study. J Pediatr. 2016 Oct;177:108-113. doi: 10.1016/j.jpeds.2016.06.051. Epub 2016 Jul 26.
- Derived from this study: PubMed 40542416Monfredini C, Cavallin F, Ouedraogo P, Ezzahraoui L, Pasta E, Trevisanuto D, Villani PE. Intubating laryngeal airway vs. direct laryngoscope: a crossover randomized controlled neonatal manikin trial. Ital J Pediatr. 2025 Jun 20;51(1):196. doi: 10.1186/s13052-025-01988-8.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Intubating laryngeal mask and Direct laryngoscopy in people with Neonatal Disease and Intubation; Difficult or Failed, run by University Hospital Padova.
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 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Daniele Trevisanuto (3406632734, daniele.trevisanuto@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success at the first attempt (time frame: 3 minutes after the initiation of the procedure). 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 NCT06263790, which also lists 6 linked publications.
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 Feb 2024.