Respiratory Distress SyndromeNCT03265548
Video Laryngoscopy in Newborn Babies V1
A study testing Video Laryngoscope in people with Respiratory Distress Syndrome, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Our research questions are 1. Will the use of a video laryngoscope lead to decreased attempts 2. Does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2016to 1 Aug 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any baby requiring intubation on a neonatal unit
Who cannot join
- Infants will not be recruited if they are in extremis requiring immediate intubation by a senior experienced operator who will use his/her own preferred method. Infants who will be intubated nasally will not be included as this technique is not usually taught to registrars.
- Any baby with a congenital airway malformation will not be included in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon and Exeter NHS Foundation Trust
Exeter, Devon, EX25DW
About this study
Official title: Comparison Between Direct Laryngoscopy and Video Laryngoscopy for Neonatal Intubation. Confidence of Staff and Number of Attempts to Successful Intubation
Our research questions are
- Will the use of a video laryngoscope lead to decreased attempts
- Does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.
Read the detailed description
Neonatal intubation is a technically difficult, but essential, skill to learn, involving passing a plastic tube through the vocal cords, into the trachea. Current practice involves using a laryngoscope to directly visualise the cords, however this technique does not allow the supervisor to witness the tube passing through the cords. Video laryngoscopes have a camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that is seen with direct view. In addition, the image is projected onto a screen, allowing all members of the team to visualise the intubation and therefore provide real time guidance as well as increased confidence in the outcome of the attempt. Video laryngoscopes are used in neonates in other specialities, for example Ear Nose and throat or respiratory physicians, and are becoming routinely used by neonatologists. The research questions are whether using a video laryngoscope will lead to decreased attempts, which in turn will potentially result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.
The aim is to recruit 40 babies and randomly allocate the participant to either direct laryngoscopy or video laryngoscopy for elective intubations. Number of attempts to successful intubation would be recorded, in addition to confidence of supervisor and the team regarding the outcome of the attempt.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Video Laryngoscope
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video LaryngoscopeDevice
The use of video laryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Usual Direct view laryngoscopy |
| Intervention | Experimental | Video laryngoscopy Receives: Device: Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempts to successful intubation
How many attempts before successful intubation
Measured: Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation
Team confidence around tube placement at the time of tube placement
Continuous line to score the confidence of the individuals in the team
Measured: immediately after the intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jun 2016
- Primary completion1 Feb 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Derriford Hospital
- Responsible party
- Sponsor
- Investigators
- Bartle Dr David, MBChB, Principal investigator, Consultant at Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265548
- Sponsor's protocol ID
- 16/SW/0013
- Status last verified
- Mar 2019
- First submitted
- 25 Aug 2017
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Direct Laryngoscopy and Video Laryngoscopy for Neonatal Intubation. Confidence of Staff and Number of Attempts to Successful Intubation
- ClinicalTrials.gov ID
- NCT03265548
- Acronym / sponsor ID
- 16/SW/0013
- Conditions
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Derriford Hospital
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 29 Aug 2017 (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.
Our research questions are
- Will the use of a video laryngoscope lead to decreased attempts
- Does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.
Detailed description
Neonatal intubation is a technically difficult, but essential, skill to learn, involving passing a plastic tube through the vocal cords, into the trachea. Current practice involves using a laryngoscope to directly visualise the cords, however this technique does not allow the supervisor to witness the tube passing through the cords. Video laryngoscopes have a camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that is seen with direct view. In addition, the image is projected onto a screen, allowing all members of the team to visualise the intubation and therefore provide real time guidance as well as increased confidence in the outcome of the attempt. Video laryngoscopes are used in neonates in other specialities, for example Ear Nose and throat or respiratory physicians, and are becoming routinely used by neonatologists. The research questions are whether using a video laryngoscope will lead to decreased attempts, which in turn will potentially result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.
The aim is to recruit 40 babies and randomly allocate the participant to either direct laryngoscopy or video laryngoscopy for elective intubations. Number of attempts to successful intubation would be recorded, in addition to confidence of supervisor and the team regarding the outcome of the attempt.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Usual Direct view laryngoscopy |
| Intervention | Experimental | Device: Video LaryngoscopeVideo laryngoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any baby requiring intubation on a neonatal unit
Key exclusion criteria (2 listed)
- Infants will not be recruited if they are in extremis requiring immediate intubation by a senior experienced operator who will use his/her own preferred method. Infants who will be intubated nasally will not be included as this technique is not usually taught to registrars.
- Any baby with a congenital airway malformation will not be included in the study
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 LaryngoscopeThe use of video laryngoscopy | Device | Intervention |
Primary outcome
Number of attempts to successful intubation
Time frame: Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation
How many attempts before successful intubation
Team confidence around tube placement at the time of tube placement
Time frame: immediately after the intubation
Continuous line to score the confidence of the individuals in the team
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 28 Mar 2019.
- 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.
Bartle Dr David, MBChB principal investigator
Consultant at Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Laryngoscope in people with Respiratory Distress Syndrome, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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 2 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 28 Mar 2019. 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 United Kingdom. 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?
Number of attempts to successful intubation (time frame: Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2019.