Education, MedicalNCT03035175
Using Video Laryngoscopy for Neonatal Intubation
A study testing Video Laryngoscopy and Traditional Laryngoscopy in people with Education, Medical, run by University of Rochester.
Trial summary
This study examines the effectiveness of utilizing video laryngoscopy to give real-time guidance during neonatal intubations to improve residents' success at performing intubations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Medical
- What is being tested?
- Video Laryngoscopy and Traditional Laryngoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Aug 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of Rochester
Who cannot join
- Residents who declined participation
About this study
Official title: A Randomized Control Trial: Does Guidance Using Video Laryngoscopy Improve Residents' Success in Neonatal Intubation?
This study examines the effectiveness of utilizing video laryngoscopy to give real-time guidance during neonatal intubations to improve residents' success at performing intubations.
Read the detailed description
To evaluate whether residents who receive guidance from a supervisor concurrently viewing the neonate's airway via video laryngoscopy will have a higher rate of successful neonatal intubations than residents receiving guidance using traditional direct laryngoscopy.
The investigators conducted a randomized controlled trial involving 48 first and second year pediatric and medicine-pediatric residents who received either video-facilitated (VDL) or traditional (TDL) supervisor guidance during direct laryngoscopy. Residents attempted intubations in the neonatal intensive care unit according to their randomization group. The primary outcome was a successful intubation that occurred within two attempts.
- Conditions
- Education, Medical
- Being tested
- Video Laryngoscopy, Traditional Laryngoscopy
- Keywords
- Residences, Video Laryngoscopy, Intubations, Neonatal, NICU, neonates, Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopyOther
Also called Technology-Assisted Instruction
Residents intubate using video laryngoscopy.
Traditional LaryngoscopyOther
Also called Traditional Instruction
Residents intubate without using video laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Video Laryngoscopy Group | Experimental | Subjects enrolled in this arm received real-time guidance from a supervisor utilizing the screen of the video laryngoscope while the subjects performed direct neonatal intubations in the NICU. Receives: Other: Video Laryngoscopy |
| Traditional Laryngoscopy Group | Active comparator | Subjects enrolled in this arm, received traditional guidance while they performed direct neonatal intubations in the NICU. Receives: Other: Traditional Laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Successful Intubations
A successful intubation is defined as the placement of an endotracheal tube in the infant's trachea within two attempts.
Measured: 12 months
Secondary outcomes (5)
Number of successful intubations by resident year
Measured: 12 months
Number of residents with successful intubations on the first and subsequent patients
Measured: 12 months
Average length of time of intubation attempts
Measured: 12 months
Number of both serious and non-serious adverse events
Measured: 12 months
Number of successful intubations by residency program
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study startMay 2014
- Primary completionJun 2016
- Study completionAug 2016
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 Education, MedicalStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Dadiz, DO, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035175
- Sponsor's protocol ID
- RSRB00051876
- Status last verified
- Oct 2023
- First submitted
- 24 Jan 2017
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.
PubMed 23562374Falck AJ, Escobedo MB, Baillargeon JG, Villard LG, Gunkel JH. Proficiency of pediatric residents in performing neonatal endotracheal intubation. Pediatrics. 2003 Dec;112(6 Pt 1):1242-7. doi: 10.1542/peds.112.6.1242.
PubMed 14654592O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.
PubMed 26482669Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.
PubMed 26908701
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial: Does Guidance Using Video Laryngoscopy Improve Residents' Success in Neonatal Intubation?
- ClinicalTrials.gov ID
- NCT03035175
- Acronym / sponsor ID
- RSRB00051876
- Conditions
- Education, Medical
- Keywords
- Residences, Video Laryngoscopy, Intubations, Neonatal, NICU, neonates, Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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 examines the effectiveness of utilizing video laryngoscopy to give real-time guidance during neonatal intubations to improve residents' success at performing intubations.
Detailed description
To evaluate whether residents who receive guidance from a supervisor concurrently viewing the neonate's airway via video laryngoscopy will have a higher rate of successful neonatal intubations than residents receiving guidance using traditional direct laryngoscopy.
The investigators conducted a randomized controlled trial involving 48 first and second year pediatric and medicine-pediatric residents who received either video-facilitated (VDL) or traditional (TDL) supervisor guidance during direct laryngoscopy. Residents attempted intubations in the neonatal intensive care unit according to their randomization group. The primary outcome was a successful intubation that occurred within two attempts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Laryngoscopy Group | Experimental | Other: Video LaryngoscopySubjects enrolled in this arm received real-time guidance from a supervisor utilizing the screen of the video laryngoscope while the subjects performed direct neonatal intubations in the NICU. |
| Traditional Laryngoscopy Group | Active comparator | Other: Traditional LaryngoscopySubjects enrolled in this arm, received traditional guidance while they performed direct neonatal intubations in the NICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1st and 2nd Year Pediatric and Medicine-Pediatric Residents at the University of Rochester
Key exclusion criteria (1 listed)
- Residents who declined participation
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 |
|---|---|---|
| Video LaryngoscopyAlso: Technology-Assisted InstructionResidents intubate using video laryngoscopy. | Other | Video Laryngoscopy Group |
| Traditional LaryngoscopyAlso: Traditional InstructionResidents intubate without using video laryngoscopy. | Other | Traditional Laryngoscopy Group |
Primary outcome
Number of Successful Intubations
Time frame: 12 months
A successful intubation is defined as the placement of an endotracheal tube in the infant's trachea within two attempts.
5 secondary outcomes
Number of successful intubations by resident year
Time frame: 12 months
Number of residents with successful intubations on the first and subsequent patients
Time frame: 12 months
Average length of time of intubation attempts
Time frame: 12 months
Number of both serious and non-serious adverse events
Time frame: 12 months
Number of successful intubations by residency program
Time frame: 12 months
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 5 Oct 2023.
- Background: PubMed 23562374Haubner LY, Barry JS, Johnston LC, Soghier L, Tatum PM, Kessler D, Downes K, Auerbach M. Neonatal intubation performance: room for improvement in tertiary neonatal intensive care units. Resuscitation. 2013 Oct;84(10):1359-64. doi: 10.1016/j.resuscitation.2013.03.014. Epub 2013 Apr 3.
- Background: PubMed 14654592Falck AJ, Escobedo MB, Baillargeon JG, Villard LG, Gunkel JH. Proficiency of pediatric residents in performing neonatal endotracheal intubation. Pediatrics. 2003 Dec;112(6 Pt 1):1242-7. doi: 10.1542/peds.112.6.1242.
- Background: PubMed 26482669O'Shea JE, Thio M, Kamlin CO, McGrory L, Wong C, John J, Roberts C, Kuschel C, Davis PG. Videolaryngoscopy to Teach Neonatal Intubation: A Randomized Trial. Pediatrics. 2015 Nov;136(5):912-9. doi: 10.1542/peds.2015-1028. Epub 2015 Oct 19.
- Background: PubMed 26908701Moussa A, Luangxay Y, Tremblay S, Lavoie J, Aube G, Savoie E, Lachance C. Videolaryngoscope for Teaching Neonatal Endotracheal Intubation: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20152156. doi: 10.1542/peds.2015-2156. Epub 2016 Feb 12.
- 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.
Rita Dadiz, DO principal investigator
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngoscopy and Traditional Laryngoscopy in people with Education, Medical, run by University of Rochester.
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 5 Oct 2023. 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?
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 Successful Intubations (time frame: 12 months). 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 NCT03035175, 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 5 Oct 2023.