Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000835943
Ethics application status
Approved
Date submitted
20/05/2020
Date registered
24/08/2020
Date last updated
24/08/2020
Date data sharing statement initially provided
24/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Incidence of vocal cord paresis and evaluation of a multi-modal education program and structured multidisciplinary pathway in patients after congenital heart surgery
Scientific title
Incidence of vocal cord paresis and evaluation of a multi-modal education program and structured multidisciplinary pathway in patients after congenital heart surgery
Secondary ID [1] 301341 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vocal cord paresis 317555 0
Congenital heart disease 317556 0
Condition category
Condition code
Cardiovascular 315642 315642 0 0
Other cardiovascular diseases
Surgery 315643 315643 0 0
Other surgery
Injuries and Accidents 315644 315644 0 0
Other injuries and accidents
Respiratory 315777 315777 0 0
Other respiratory disorders / diseases
Neurological 315778 315778 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A collaborative working group comprising nurses, speech pathologists, dietitians and cardiac surgeons developed an easy-to-follow guide to managing nasogastric feeding. The pathway seeks to prime infants for success in safely commencing and transitioning to oral feeds in the following key ways:
1. Patients are not considered suitable for an initial oral feeding trial prior to clearing 4 criteria related to underlying known risk factors for feeding dysfunction or aspiration.
2. Patients are assessed by experienced speech pathologists who are able to identify additional risk factors for, or clinical signs of, swallowing difficulty and aspiration. Crucially, the speech pathologist can then immediately implement clinical strategies and modifications (therapeutic or prophylactic) to prevent aspiration and improve swallowing safety.
3. Patients are concurrently referred to Paediatric Otorhinolaryngologists for assessment of vocal cord function via naso-endoscopy. Diagnosis of potential vocal cord palsy, along with other incidental observations of the upper airway, aid in the interpretation of the clinical feeding evaluation and team decision making regarding the progression of oral feeds.
4. Once considered safe for progressing with oral feeds without direct speech pathology supervision (with safety modifications or precautions in place as required), the frequency and duration of oral feeds are increased as tolerated by the patient, with ongoing close monitoring by the medical and feeding teams.
5. Where clinical signs of swallowing difficulty or suspicion of aspiration persist despite clinical intervention, the patient is referred for further evaluation and medical imaging as clinically indicated.

A six-month multi-modal, multi-disciplinary education program will be used to implement the feeding pathway. The education program is guided by the Knowledge-to-Action (KTA) Framework and the Consolidated Framework for Implementation Research (CFIR). Investigators will use the frameworks to assist with identification of gaps in knowledge, adaptation of evidence to context, assessment of barriers and facilitators to knowledge use, selection and implementation of interventions, monitoring knowledge use, and outcomes evaluation. Semi-structured interviews of staff involved in managing vocal cord paresis will be conducted in the month before implementation to identify barriers and enablers to adoption. Staff knowledge will also be assessed. Interviews will be repeated post implementation. Interviews will be completed by the ward educator for cardiology.

The education program will comprise of short education sessions (maximum 5 mins) and will include a summary of vocal cord palsy and its diagnosis and management, discussion of the care pathway, and a real-life surgical scenario to analyse in tandem with the pathway. Sessions will be conducted on an ad hoc opportunistic basis over a six-month period and will be led by the clinical educator with the goal of running 20 sessions in total for the participating ward and the speech pathology team. Information will also be distributed in the ward newsletter and on education boards in the clinical area.

To ensure ongoing translation of the pathway and integration into routine clinical practice, education sessions will be continued every month and audit of use of the pathway will be integrated into routine quality assurance practices within the ward. Facilitators will be engaged by expression of interest to consolidate education and reinforce use of the framework. An information sheet will also be provided to all families with children that have a diagnosis of vocal cord palsy. The sheet will be provided by either the cardiac surgical care coordinators or cardiac surgery fellows at the time of diagnosis of VCP.
Intervention code [1] 317637 0
Early detection / Screening
Intervention code [2] 317638 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323875 0
Diagnosis of vocal cord paresis through flexible direct laryngoscopy and/or laryngeal ultrasound. Flexible direct laryngoscopy will be performed by a trained paediatric otolaryngologist/Fellow/Registrar using a validated Nasendoscope (Storz CMOS 11102CMM\CMK). Assessment of movement of both vocal cords will be made and paresis identified. Bedside laryngeal ultrasound will be performed by a paediatric ultrasonographer using a standard ultrasound machine. The patient will be positioned in a supine position with the neck extended by placing a rolled towel between the shoulders. The ultrasound probe will be placed transversely over the midline to scan the anterior neck at the level of the thyroid cartilage until the vocal cords can be visualised. Images will be obtained with the child relaxed and then crying or vocalising. Vocal cords will be assessed for symmetrical abduction and adduction during breathing, swallowing saliva and phonation. Complete adduction will be confirmed on static imaging by the presence of centrally inverted “T” formed by the folds of the vocal cords. Complete abduction will be confirmed by the presence of a centrally inverted “V”. VCP will be defined as decreased or no movement in one or both vocal cords and reported as partial or full paresis.
Timepoint [1] 323875 0
Hospital discharge
Secondary outcome [1] 383120 0
Growth as measured using height (using stadiometer) and weight (using calibrated scales).
Timepoint [1] 383120 0
Discharge, 6 months post discharge
Secondary outcome [2] 383121 0
Recovery of vocal cord function using either flexible direct laryngoscopy and/or laryngeal ultrasound. Flexible direct laryngoscopy will be performed by a trained paediatric otolaryngologist/Fellow/Registrar using a validated Nasendoscope (Storz CMOS 11102CMM\CMK). Assessment of movement of both vocal cords will be made and paresis identified. Bedside laryngeal ultrasound will be performed by a paediatric ultrasonographer using a standard ultrasound machine. The patient will be positioned in a supine position with the neck extended by placing a rolled towel between the shoulders. The ultrasound probe will be placed transversely over the midline to scan the anterior neck at the level of the thyroid cartilage until the vocal cords can be visualised. Images will be obtained with the child relaxed and then crying or vocalising. Vocal cords will be assessed for symmetrical abduction and adduction during breathing, swallowing saliva and phonation. Complete adduction will be confirmed on static imaging by the presence of centrally inverted “T” formed by the folds of the vocal cords. Complete abduction will be confirmed by the presence of a centrally inverted “V”. VCP will be defined as decreased or no movement in one or both vocal cords and reported as partial or full paresis.
Timepoint [2] 383121 0
6 months post discharge from hospital
Secondary outcome [3] 383122 0
Time to achieve oral feeding (number of days until the participant is consuming food orally).
Timepoint [3] 383122 0
Assessed at both hospital discharge and again at 6 months post hospital discharge (if child not feeding at hospital discharge)
Secondary outcome [4] 383123 0
Length of hospital stay (extracted from electronic medical record)
Timepoint [4] 383123 0
Hospital discharge
Secondary outcome [5] 383124 0
Vocal cord paresis related complication such as extubation failure, inadequate weight gain, respiratory infection or aspiration assessed through documentation in clinical record.
Timepoint [5] 383124 0
Discharge from hospital, 6 months following hospital discharge
Secondary outcome [6] 383125 0
Surgical intervention for vocal cord paresis (PEG, gastrostomy, tracheostomy, nasogastric tube insertion). Data will be extracted from electronic medical record.
Timepoint [6] 383125 0
Hospital discharge, 6 months following hospital discharge

Eligibility
Key inclusion criteria
Children aged 0-18 years who underwent congenital heart surgery involving the aortic arch, patent ductus arteriosus and left pulmonary artery.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior diagnosis of vocal cord paresis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/09/2019
Date of last participant enrolment
Anticipated
30/09/2020
Actual
Date of last data collection
Anticipated
30/09/2021
Actual
Sample size
Target
60
Accrual to date
56
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16726 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 30328 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 305775 0
Charities/Societies/Foundations
Name [1] 305775 0
Children's Hospital Foundation
Country [1] 305775 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Centre for Children's Health Research
62 Graham Street
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 306212 0
Hospital
Name [1] 306212 0
Queensland Children's Hospital
Address [1] 306212 0
501 Stanley Street
South Brisbane QLD 4101
Country [1] 306212 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306048 0
Queensland Children's Hospital HREC
Ethics committee address [1] 306048 0
Ethics committee country [1] 306048 0
Australia
Date submitted for ethics approval [1] 306048 0
23/11/2018
Approval date [1] 306048 0
20/12/2018
Ethics approval number [1] 306048 0
HREC/2018/QCHQ/49022

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102542 0
A/Prof Nelson Alphonso
Address 102542 0
Level 7, Clinical Directorate
501 Stanley Street
Queensland Children's Hospital
South Brisbane QLD 4101
Country 102542 0
Australia
Phone 102542 0
+61 7 3068 5775
Fax 102542 0
Email 102542 0
[email protected]
Contact person for public queries
Name 102543 0
Jessica Suna
Address 102543 0
Level 4, CCHR
62 Graham Street
Queensland Children's Hospital
South Brisbane QLD 4101
Country 102543 0
Australia
Phone 102543 0
+61 7 3069 7256
Fax 102543 0
Email 102543 0
[email protected]
Contact person for scientific queries
Name 102544 0
Jessica Suna
Address 102544 0
Level 4, CCHR
62 Graham Street
Queensland Children's Hospital
South Brisbane QLD 4101
Country 102544 0
Australia
Phone 102544 0
+61 7 3069 7256
Fax 102544 0
Email 102544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This study is in part an implementation science study and datasets are not well suited to IPD sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.