Recurrent Laryngeal Nerve InjuriesPREMARNCT04994964
Recurrent Nerve Monitoring During Aortic Arch Repair
A study testing Electromyography in people with Recurrent Laryngeal Nerve Injuries and Aortic Arch Hypoplasia, run by Birmingham Women's and Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. This causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Recurrent Laryngeal Nerve Injuries, Aortic Arch Hypoplasia
- What is being tested?
- Electromyography
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2021to May 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Only patients with parents/ carers able to give informed consent to participation in the trial will be included. • Male and female patients will be included
- Only Neonates (babies less than 28 days of age) will be included in the study.
- Only patients undergoing repair of the aortic arch via median sternotomy will be included in the study
Who cannot join
- Patients with severe abnormalities of the airway, such that they are unlikely to be extubated within 7 days of the aortic arch repair surgery will be excluded from participation, as assessment of vocal cord function will be difficult/ impossible in such patients.
- Patients with parents/ carers who are unable to give informed consent to participation in the trial will be excluded from participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Birmingham Children's Hospital
Birmingham, West Midlands, B4 6NH
Phil Botha, PhD, +44 121 333 9999 ext. 9435, p.botha@nhs.net
About this study
Official title: Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair
Almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. This causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. As these children can have a vulnerable circulation, aspiration events can reduce survival and poor weight gain has been shown to correlate with poorer outcomes after surgery.
In other types of surgery in the neck, monitors can be used to alert the surgeon to when injury is occurring to the recurrent nerve. To date, this type of monitoring has not been possible in newborns. This study aims to investigate if this type of monitoring is feasible in newborns undergoing aortic arch repair, to prevent recurrent nerve injury.
- Being tested
- Electromyography
- Medical subject headings
- Recurrent Laryngeal Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectromyographyDiagnostic test
Needle vocal cord electromyography using Medtronic NIM monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal cord EMG - Burst amplitude (mV)
Feasibility of performing vocal cord EMG during neonatal arch repair
Measured: Intra-operative (1 hour)
Vocal cord EMG - Burst duration (ms)
Feasibility of performing vocal cord EMG during neonatal arch repair
Measured: Intra-operative (1 hour)
Vocal cord EMG - Burst frequency (Hz)
Feasibility of performing vocal cord EMG during neonatal arch repair
Measured: Intra-operative (1 hour)
Vocal cord EMG - Interburst interval (ms)
Feasibility of performing vocal cord EMG during neonatal arch repair
Measured: Intra-operative (1 hour)
Vocal cord EMG - Signal to noise ratio (mV)
Feasibility of performing vocal cord EMG during neonatal arch repair
Measured: Intra-operative (1 hour)
Correlation of Vocal cord EMG with post-operative palsy
Vocal cord ultrasound
Measured: Post extubation / 1 week post-operatively
Secondary outcomes (1)
Neuromuscular blockade
Influence of timing of neuromuscular blockade on EMG signal
Measured: Intra-operative (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start23 Mar 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Laryngeal Nerve InjuriesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Phil Botha, PhD, Principal investigator, Birmingham Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994964
- Sponsor's protocol ID
- 20/BC/CARDIO/NO/444
- Acronym
- PREMAR
- Status last verified
- Apr 2021
- First submitted
- 11 Mar 2021
- Last updated
- 6 Aug 2021
- Results posted
- 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 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair
- ClinicalTrials.gov ID
- NCT04994964
- Acronym / sponsor ID
- PREMAR / 20/BC/CARDIO/NO/444
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Birmingham Women's and Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 6 Aug 2021 (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.
Almost half of newborns undergoing surgery to repair narrowing or interruption of the aortic arch will suffer injury to the recurrent laryngeal nerve. This causes a weak voice and can lead to problems with feeding including aspiration of milk feed after the surgery. As these children can have a vulnerable circulation, aspiration events can reduce survival and poor weight gain has been shown to correlate with poorer outcomes after surgery.
In other types of surgery in the neck, monitors can be used to alert the surgeon to when injury is occurring to the recurrent nerve. To date, this type of monitoring has not been possible in newborns. This study aims to investigate if this type of monitoring is feasible in newborns undergoing aortic arch repair, to prevent recurrent nerve injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Only patients with parents/ carers able to give informed consent to participation in the trial will be included. • Male and female patients will be included
- Only Neonates (babies less than 28 days of age) will be included in the study.
- Only patients undergoing repair of the aortic arch via median sternotomy will be included in the study
Key exclusion criteria (2 listed)
- Patients with severe abnormalities of the airway, such that they are unlikely to be extubated within 7 days of the aortic arch repair surgery will be excluded from participation, as assessment of vocal cord function will be difficult/ impossible in such patients.
- Patients with parents/ carers who are unable to give informed consent to participation in the trial will be excluded from 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 |
|---|---|---|
| ElectromyographyNeedle vocal cord electromyography using Medtronic NIM monitor | Diagnostic test | – |
Primary outcome
Vocal cord EMG - Burst amplitude (mV)
Time frame: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Burst duration (ms)
Time frame: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Burst frequency (Hz)
Time frame: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Interburst interval (ms)
Time frame: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Signal to noise ratio (mV)
Time frame: Intra-operative (1 hour)
Feasibility of performing vocal cord EMG during neonatal arch repair
Correlation of Vocal cord EMG with post-operative palsy
Time frame: Post extubation / 1 week post-operatively
Vocal cord ultrasound
1 secondary outcome
Neuromuscular blockade
Time frame: Intra-operative (1 hour)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- 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.
Phil Botha, PhD principal investigator
Birmingham Women's and Children's 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 Electromyography in people with Recurrent Laryngeal Nerve Injuries and Aortic Arch Hypoplasia, run by Birmingham Women's and Children's 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 3 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: status not confirmed, as of the sponsor's last update on 6 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phil Botha, PhD (+44 121 333 9999 ext. 9435, p.botha@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocal cord EMG - Burst amplitude (mV) (time frame: Intra-operative (1 hour)). The study lists 6 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 6 Aug 2021.