Neonatal DiseaseIntTabNCT06474572
Applied Forces During Neonatal Intubation at Different Heights of the Resuscitation Table
A study testing Direct laryngoscope and table at xiphoid level, Videolaryngoscope and table at xiphoid level and Direct laryngoscope and table at umbilical level in people with Neonatal Disease and Intubation, run by University Hospital Padova.
Trial summary
The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated. 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
- What is being tested?
- Direct laryngoscope and table at xiphoid level, Videolaryngoscope and table at xiphoid level and Direct laryngoscope and table at umbilical level
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 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 and PICU consultants, and pediatric residents
Who cannot join
- Refusal to participate
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table: a Randomized Crossover Manikin Study
The study aims to compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated.
This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.
Read the detailed description
Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures.
Objectives: To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time, and participants' opinions on the procedures were investigated.
Methods: This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.
- Conditions
- Neonatal Disease, Intubation
- Being tested
- Direct laryngoscope and table at xiphoid level, Videolaryngoscope and table at xiphoid level, Direct laryngoscope and table at umbilical level, Videolaryngoscope and table at umbilical level
- Keywords
- Neonate, Intubation, Direct laryngoscopy, Video laryngoscopy, Forces, Simulation
- 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.
Direct laryngoscope and table at xiphoid levelDevice
Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level
Videolaryngoscope and table at xiphoid levelDevice
Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level
Direct laryngoscope and table at umbilical levelDevice
Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level
Videolaryngoscope and table at umbilical levelDevice
Participants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level
| Study group | Role | What they receive |
|---|---|---|
| Direct laryngoscope and table at xiphoid level | Active comparator | Participants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level Receives: Device: Direct laryngoscope and table at xiphoid level |
| Videolaryngoscope and table at xiphoid level | Active comparator | Participants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level Receives: Device: Videolaryngoscope and table at xiphoid level |
| Direct laryngoscope and table at umbilical level | Active comparator | Participants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level Receives: Device: Direct laryngoscope and table at umbilical level |
| Videolaryngoscope and table at umbilical level | Experimental | Participants will be required to intubate the manikin with a video laryngoscope and table at umbilical level Receives: Device: Videolaryngoscope and table at umbilical level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitide of applied forces (Newton)
Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation
Measured: 3 minutes
Secondary outcomes (3)
Percentage of participants achieving the intubation 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: 30 seconds
Total time of intubation
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
Participant's opinions about the procedure
Participants will report: their preference about table height and device; perceived difficulty using a Likert scale (1= not difficult, 5=very difficult)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 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
- 32 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
- NCT06474572
- Sponsor's protocol ID
- NEOUNIPD5(2024)
- Acronym
- IntTab
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans P, Shults J, Weinberg DD, Napolitano N, Ades A, Johnston L, Levit O, Brei B, Krick J, Sawyer T, Glass K, Wile M, Hollenberg J, Rumpel J, Moussa A, Verreault A, Abou Mehrem A, Howlett A, McKanna J, Nishisaki A, Foglia EE. Intubation Competence During Neonatal Fellowship Training. Pediatrics. 2021 Jul;148(1):e2020036145. doi: 10.1542/peds.2020-036145. Epub 2021 Jun 25.
PubMed 34172556Pouppirt NR, Nassar R, Napolitano N, Nawab U, Nishisaki A, Nadkarni V, Ades A, Foglia EE. Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. J Pediatr. 2018 Oct;201:281-284.e1. doi: 10.1016/j.jpeds.2018.05.046. Epub 2018 Jul 3.
PubMed 29980290Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.
PubMed 38709215Xue FS, Li RP, Liu GP. Dynamic optimization of height relation between anaesthetist's chest and patient's face during tracheal intubation. Br J Anaesth. 2015 Feb;114(2):348-9. doi: 10.1093/bja/aeu479. No abstract available.
PubMed 25596228Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.
PubMed 32152886Cavallin F, Pasquali G, Maglio S, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces during neonatal intubation with direct and video laryngoscopy at different bed elevations: a randomized crossover manikin study. Eur J Pediatr. 2025 Nov 5;184(12):732. doi: 10.1007/s00431-025-06524-8.
PubMed 41191125
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Forces During Neonatal Intubation With Direct and Video Laryngoscopy at Different Heights of the Resuscitation Table: a Randomized Crossover Manikin Study
- ClinicalTrials.gov ID
- NCT06474572
- Acronym / sponsor ID
- IntTab / NEOUNIPD5(2024)
- Conditions
- Neonatal Disease, Intubation
- Keywords
- Neonate, Intubation, Direct laryngoscopy, Video laryngoscopy, Forces, Simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Jun 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 applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time and participants' opinion on the procedures were investigated.
This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table.
Detailed description
Background: Endotracheal intubation is an important life-saving procedure for critically ill neonates. Some procedure-related aspects may affect the quality of the intubation. Optimizing the relative height between patient and operator may improve intubation procedures.
Objectives: To compare the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Furthermore, the success at the first attempt, the intubation time, and participants' opinions on the procedures were investigated.
Methods: This is an unblinded, randomized, controlled, crossover trial on the applied forces during intubation of a newborn manikin with direct and video laryngoscope at different heights of the resuscitation table. Participants will be Level III NICU/PICU consultants, and pediatric residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the forces applied on the neonatal manikin during the intubation. The secondary outcome measures will be the success of the first attempt, the total time of intubation, and participants' opinions about the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Direct laryngoscope and table at xiphoid level | Active comparator | Device: Direct laryngoscope and table at xiphoid levelParticipants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level |
| Videolaryngoscope and table at xiphoid level | Active comparator | Device: Videolaryngoscope and table at xiphoid levelParticipants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level |
| Direct laryngoscope and table at umbilical level | Active comparator | Device: Direct laryngoscope and table at umbilical levelParticipants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level |
| Videolaryngoscope and table at umbilical level | Experimental | Device: Videolaryngoscope and table at umbilical levelParticipants will be required to intubate the manikin with a video laryngoscope and table at umbilical level |
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 and PICU consultants, and pediatric residents
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Direct laryngoscope and table at xiphoid levelParticipants will be required to intubate the manikin with a direct laryngoscope and table at xiphoid level | Device | Direct laryngoscope and table at xiphoid level |
| Videolaryngoscope and table at xiphoid levelParticipants will be required to intubate the manikin with a video laryngoscope and table at xiphoid level | Device | Videolaryngoscope and table at xiphoid level |
| Direct laryngoscope and table at umbilical levelParticipants will be required to intubate the manikin with a direct laryngoscope and table at umbilical level | Device | Direct laryngoscope and table at umbilical level |
| Videolaryngoscope and table at umbilical levelParticipants will be required to intubate the manikin with a videolaryngoscope and table at umbilical level | Device | Videolaryngoscope and table at umbilical level |
Primary outcome
Magnitide of applied forces (Newton)
Time frame: 3 minutes
Magnitude of forces (measured in Newton) applied to the epiglottis and the palate of the neonatal manikin during the intubation
3 secondary outcomes
Percentage of participants achieving the intubation success at the first attempt
Time frame: 30 seconds
Total time of intubation
Time frame: 3 minutes
Participant's opinions about the procedure
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Background: PubMed 34172556Evans P, Shults J, Weinberg DD, Napolitano N, Ades A, Johnston L, Levit O, Brei B, Krick J, Sawyer T, Glass K, Wile M, Hollenberg J, Rumpel J, Moussa A, Verreault A, Abou Mehrem A, Howlett A, McKanna J, Nishisaki A, Foglia EE. Intubation Competence During Neonatal Fellowship Training. Pediatrics. 2021 Jul;148(1):e2020036145. doi: 10.1542/peds.2020-036145. Epub 2021 Jun 25.
- Background: PubMed 29980290Pouppirt NR, Nassar R, Napolitano N, Nawab U, Nishisaki A, Nadkarni V, Ades A, Foglia EE. Association Between Video Laryngoscopy and Adverse Tracheal Intubation-Associated Events in the Neonatal Intensive Care Unit. J Pediatr. 2018 Oct;201:281-284.e1. doi: 10.1016/j.jpeds.2018.05.046. Epub 2018 Jul 3.
- Background: PubMed 38709215Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.
- Background: PubMed 25596228Xue FS, Li RP, Liu GP. Dynamic optimization of height relation between anaesthetist's chest and patient's face during tracheal intubation. Br J Anaesth. 2015 Feb;114(2):348-9. doi: 10.1093/bja/aeu479. No abstract available.
- Background: PubMed 32152886Gordon JK, Bertram VE, Cavallin F, Parotto M, Cooper RM. Direct versus indirect laryngoscopy using a Macintosh video laryngoscope: a mannequin study comparing applied forces. Can J Anaesth. 2020 May;67(5):515-520. doi: 10.1007/s12630-020-01583-x. Epub 2020 Mar 9.
- Derived from this study: PubMed 41191125Cavallin F, Pasquali G, Maglio S, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces during neonatal intubation with direct and video laryngoscopy at different bed elevations: a randomized crossover manikin study. Eur J Pediatr. 2025 Nov 5;184(12):732. doi: 10.1007/s00431-025-06524-8.
- 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 Direct laryngoscope and table at xiphoid level, Videolaryngoscope and table at xiphoid level and Direct laryngoscope and table at umbilical level in people with Neonatal Disease and Intubation, 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 25 Jun 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, MD (0498211489, daniele.trevisanuto@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitide of applied forces (Newton) (time frame: 3 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 NCT06474572, 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 25 Jun 2024.