Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001182482
Ethics application status
Approved
Date submitted
25/08/2016
Date registered
29/08/2016
Date last updated
29/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound for endotracheal tube position in neonates.
Scientific title
Comparison of point of care ultrasound and chest x-ray to confirm endotracheal tube position in neonates.
Secondary ID [1] 290014 0
NIL KNOWN
Universal Trial Number (UTN)
U1111-1186-8834
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Endotracheal tube position 300033 0
Condition category
Condition code
Respiratory 299928 299928 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study population will include neonates admitted to the NICU, who are ventilated and require chest x-ray for any indication. The infant will be positioned with his or her neck in neutral position. The Chest X-ray and ultrasound evaluation will be conducted preferably within two hours of each other. The same neck position will be maintained for both investigations.

The ultrasound will be conducted using high parasternal sagittal window. Aortic arch and right pulmonary artery (RPA) will be localised. The ET tube will be visualised as a double walled structure by gentle sliding movement.

The ultrasound images will be stored and compared with Chest x-ray for endotracheal tube position.
Intervention code [1] 295730 0
Early detection / Screening
Comparator / control treatment
Chest x-ray
Control group
Active

Outcomes
Primary outcome [1] 299414 0
Proportion of neonates with a successful ETT tip detection using ultrasound.
Timepoint [1] 299414 0
Once the ultrasound data is collected for all participants
Primary outcome [2] 299415 0
2. To correlate the distance between ETT tip and historical anatomical ultrasound landmarks for carina and the same distance measured by x-ray in neonates
Timepoint [2] 299415 0
Once ultrasound and x-ray data is collected for all participants
Secondary outcome [1] 327108 0
Nil
Timepoint [1] 327108 0
Nil

Eligibility
Key inclusion criteria
Any intubated neonate in NICU needing chest X ray evaluation
Minimum age
0 Days
Maximum age
2 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Newborns with complex congenital heart disease affecting relationship of aorta, pulmonary vessels and airway.
2. Newborns with major tracheo-bronchial anomalies.
3. Ultrasound will not be performed if it is deemed by the treating team that the baby is too fragile to tolerate handling.

Study design
Purpose of the study
Diagnosis
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2016
Actual
Date of last participant enrolment
Anticipated
31/01/2017
Actual
Date of last data collection
Anticipated
31/01/2017
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294384 0
Hospital
Name [1] 294384 0
The Children's Hospital at Westmead
Country [1] 294384 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
212 Hawkesbury Road, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 293233 0
None
Name [1] 293233 0
Address [1] 293233 0
Country [1] 293233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295807 0
Sydney Children's Hospital Network
Ethics committee address [1] 295807 0
212 Hawkesbury Road Westmead NSW 2145
Ethics committee country [1] 295807 0
Australia
Date submitted for ethics approval [1] 295807 0
10/07/2016
Approval date [1] 295807 0
23/08/2016
Ethics approval number [1] 295807 0
LNR/16/SCHN/259

Summary
Brief summary
This is a single-blinded study. The ultrasound and x-ray images will be stored as a study number only. They will be analysed later after completion of enrolment. The x- rays will be evaluated by paediatric radiologist (AL) blinded to the ultrasound measurements and clinical management. The x-rays will be reported as the distance from ET tip to carina and Position of ET tip in relation to vertebral body.

The ultrasound images will be analysed by investigators separately, blinded to the x-ray results and clinical management.

The results will be used to compare correlation and reliability of two methods. The distance between ET tip and carina on x-ray will be correlated with ultrasound measurements of -

1. Distance between aortic arch and ETT
2. Distance between RPA and ETT
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68546 0
Dr Swapnil R Shah
Address 68546 0
Grace NICU
Department of Neonatology
The Children's Hospital Westmead
212 Hawkesbury Road
Westmead NSW 2145
Country 68546 0
Australia
Phone 68546 0
+61 2 9845 0000
Fax 68546 0
Email 68546 0
[email protected]
Contact person for public queries
Name 68547 0
Dr Swapnil R Shah
Address 68547 0
Grace NICU
Department of Neonatology
The Children's Hospital Westmead
212 Hawkesbury Road
Westmead NSW 2145
Country 68547 0
Australia
Phone 68547 0
+61 2 9845 0000
Fax 68547 0
Email 68547 0
[email protected]
Contact person for scientific queries
Name 68548 0
Dr Hiamnshu Popat
Address 68548 0
Grace NICU
Department of Neonatology
The Children's Hospital Westmead
212 Hawkesbury Road
Westmead NSW 2145
Country 68548 0
Australia
Phone 68548 0
+61 2 9845 0000
Fax 68548 0
Email 68548 0
[email protected]

No information has been provided regarding IPD availability


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.