IntubationNCT05197868
Applied Forces During Neonatal Intubation
A study testing Intubation with traditional laryngoscope, Intubation with a straight blade video laryngoscope and Intubation with a hyper-angulated video laryngoscope in people with Intubation and Training, run by University Hospital Padova at 1 site in Italy.
Trial summary
This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade) Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intubation, Training, Neonate
- What is being tested?
- Intubation with traditional laryngoscope, Intubation with a straight blade video laryngoscope and Intubation with a hyper-angulated video laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2022to 26 Jan 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.
Who cannot join
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study
This study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)
Read the detailed description
This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.
- Conditions
- Intubation, Training, Neonate, Manikin
- Being tested
- Intubation with traditional laryngoscope, Intubation with a straight blade video laryngoscope, Intubation with a hyper-angulated video laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation with traditional laryngoscopeProcedure or surgery
Participants will be invited to intubate the mannequin with a traditional laryngoscope
Intubation with a straight blade video laryngoscopeProcedure or surgery
Intubation with a straight blade video laryngoscope
Intubation with a hyper-angulated video laryngoscopeProcedure or surgery
Participants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| Intubation with traditional laryngoscope | Active comparator | Participants will be required to intubate the manikin by using a traditional laryngoscope Receives: Procedure: Intubation with traditional laryngoscope |
| Intubation with a straight blade video laryngoscope | Experimental | Participants will be required to intubate the manikin by using a straight blade video laryngoscope Receives: Procedure: Intubation with a straight blade video laryngoscope |
| Intubation with hyper-angulated video laryngoscope | Experimental | Participants will be required to intubate the manikin by using a hyper-angulated video laryngoscope Receives: Procedure: Intubation with a hyper-angulated video laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forces applied to the epiglottis
The peak force (maximum force, expressed as Newton) applied on the epiglottis during intubation will be recorded by sensors positioned on the tip of the laryngoscope's blade.
Measured: 5 minutes
Secondary outcomes (3)
Forces applied to the palate
The peak force (maximum force, expressed as Newton) applied on the palate during intubation will be recorded by sensors positioned on the posterior side of the laryngoscope's blade.
Measured: 5 minutes
Perceived workload during intubation
Participants will be asked to report their perceived workload during intubation by using a validated tool
Measured: 20 minutes
Time of intubation
Time elapsed frmo insertion of the laryngoscope in the mouth to his removal
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start20 Jan 2022
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IntubationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
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
- NCT05197868
- Sponsor's protocol ID
- NEOUNIPD1
- Status last verified
- Jan 2022
- First submitted
- 28 Nov 2021
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balaban O, Tobias JD. Videolaryngoscopy in Neonates, Infants, and Children. Pediatr Crit Care Med. 2017 May;18(5):477-485. doi: 10.1097/PCC.0000000000001128.
PubMed 28319487Gordon 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 32152886Pouppirt 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 29980290Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.
PubMed 36788198
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Forces During Neonatal Intubation: a Randomized Crossover Mannequin Study
- ClinicalTrials.gov ID
- NCT05197868
- Acronym / sponsor ID
- NEOUNIPD1
- Conditions
- Intubation, Training, Neonate, Manikin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 20 Jan 2022 (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 study will be to compare the forces applied to mannequin airways (at epiglottis and at palate) during direct laryngoscopy and indirect video laryngoscopy with two kinds of blades (straight blade and hyper-angulated blade)
Detailed description
This is a randomized controlled crossover trial of intubation with three laryngoscope devices in a neonatal manikin model. Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study. Participants in the ABC arm will be assigned to perform the intubation with a traditional laryngoscope (A), followed by the intubation with a straight blade video laryngoscope (B) and by the intubation with hyper-angulated video laryngoscope (C). Participants in different arms will be assigned to perform the intubations in different sequences (BCA/CAB/ACB/BAC/CBA). The primary outcome measure will be the forces applied to mannequin oro-tracheal tissues during intubation with the three kinds of tools. The secondary outcome measures will be the perceived workload during intubation and intubation time with the traditional laryngoscope and the video laryngoscope.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intubation with traditional laryngoscope | Active comparator | Procedure: Intubation with traditional laryngoscopeParticipants will be required to intubate the manikin by using a traditional laryngoscope |
| Intubation with a straight blade video laryngoscope | Experimental | Procedure: Intubation with a straight blade video laryngoscopeParticipants will be required to intubate the manikin by using a straight blade video laryngoscope |
| Intubation with hyper-angulated video laryngoscope | Experimental | Procedure: Intubation with a hyper-angulated video laryngoscopeParticipants will be required to intubate the manikin by using a hyper-angulated video laryngoscope |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Level III NICU and PICU consultants, pediatric residents, anesthesiology consultants, and anesthesiology residents will be eligible to participate in the study.
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 |
|---|---|---|
| Intubation with traditional laryngoscopeParticipants will be invited to intubate the mannequin with a traditional laryngoscope | Procedure or surgery | Intubation with traditional laryngoscope |
| Intubation with a straight blade video laryngoscopeIntubation with a straight blade video laryngoscope | Procedure or surgery | Intubation with a straight blade video laryngoscope |
| Intubation with a hyper-angulated video laryngoscopeParticipants will be asked to intubate the mannequin with a hyper-angulated video laryngoscope | Procedure or surgery | Intubation with hyper-angulated video laryngoscope |
Primary outcome
Forces applied to the epiglottis
Time frame: 5 minutes
The peak force (maximum force, expressed as Newton) applied on the epiglottis during intubation will be recorded by sensors positioned on the tip of the laryngoscope's blade.
3 secondary outcomes
Forces applied to the palate
Time frame: 5 minutes
Perceived workload during intubation
Time frame: 20 minutes
Time of intubation
Time frame: 5 minutes
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 15 Feb 2022.
- Results publication: PubMed 28319487Balaban O, Tobias JD. Videolaryngoscopy in Neonates, Infants, and Children. Pediatr Crit Care Med. 2017 May;18(5):477-485. doi: 10.1097/PCC.0000000000001128.
- Results publication: 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.
- Results publication: 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.
- Derived from this study: PubMed 36788198Cavallin F, Sala C, Maglio S, Bua B, Villani PE, Menciassi A, Tognarelli S, Trevisanuto D. Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study. Can J Anaesth. 2023 May;70(5):861-868. doi: 10.1007/s12630-023-02402-9. Epub 2023 Feb 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intubation with traditional laryngoscope, Intubation with a straight blade video laryngoscope and Intubation with a hyper-angulated video laryngoscope in people with Intubation and Training, run by University Hospital Padova at 1 site in Italy.
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: finished, as of the sponsor's last update on 15 Feb 2022. 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 Italy. 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?
Forces applied to the epiglottis (time frame: 5 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 NCT05197868, which also lists 4 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 15 Feb 2022.