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Recurrent Nerve Monitoring During Aortic Arch Repair (PREMAR)

Primary Purpose

Recurrent Laryngeal Nerve Injuries, Aortic Arch Hypoplasia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Electromyography
Sponsored by
Birmingham Women's and Children's NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Recurrent Laryngeal Nerve Injuries

Eligibility Criteria

0 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Birmingham Children's HospitalRecruiting

Outcomes

Primary Outcome Measures

Vocal cord EMG - Burst amplitude (mV)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Burst duration (ms)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Burst frequency (Hz)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Interburst interval (ms)
Feasibility of performing vocal cord EMG during neonatal arch repair
Vocal cord EMG - Signal to noise ratio (mV)
Feasibility of performing vocal cord EMG during neonatal arch repair
Correlation of Vocal cord EMG with post-operative palsy
Vocal cord ultrasound

Secondary Outcome Measures

Neuromuscular blockade
Influence of timing of neuromuscular blockade on EMG signal

Full Information

First Posted
March 11, 2021
Last Updated
August 5, 2021
Sponsor
Birmingham Women's and Children's NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04994964
Brief Title
Recurrent Nerve Monitoring During Aortic Arch Repair
Acronym
PREMAR
Official Title
Pilot Study of Recurrent Laryngeal Nerve Monitoring During Neonatal Aortic Arch Repair
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Birmingham Women's and Children's NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Laryngeal Nerve Injuries, Aortic Arch Hypoplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Electromyography
Intervention Description
Needle vocal cord electromyography using Medtronic NIM monitor
Primary Outcome Measure Information:
Title
Vocal cord EMG - Burst amplitude (mV)
Description
Feasibility of performing vocal cord EMG during neonatal arch repair
Time Frame
Intra-operative (1 hour)
Title
Vocal cord EMG - Burst duration (ms)
Description
Feasibility of performing vocal cord EMG during neonatal arch repair
Time Frame
Intra-operative (1 hour)
Title
Vocal cord EMG - Burst frequency (Hz)
Description
Feasibility of performing vocal cord EMG during neonatal arch repair
Time Frame
Intra-operative (1 hour)
Title
Vocal cord EMG - Interburst interval (ms)
Description
Feasibility of performing vocal cord EMG during neonatal arch repair
Time Frame
Intra-operative (1 hour)
Title
Vocal cord EMG - Signal to noise ratio (mV)
Description
Feasibility of performing vocal cord EMG during neonatal arch repair
Time Frame
Intra-operative (1 hour)
Title
Correlation of Vocal cord EMG with post-operative palsy
Description
Vocal cord ultrasound
Time Frame
Post extubation / 1 week post-operatively
Secondary Outcome Measure Information:
Title
Neuromuscular blockade
Description
Influence of timing of neuromuscular blockade on EMG signal
Time Frame
Intra-operative (1 hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phil Botha, PhD
Phone
+44 121 333 9999
Ext
9435
Email
p.botha@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phil Botha, PhD
Organizational Affiliation
Birmingham Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phil Botha, PhD
Phone
+44 121 333 9999
Ext
9435
Email
p.botha@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No

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Recurrent Nerve Monitoring During Aortic Arch Repair

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