Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000539932
Ethics application status
Approved
Date submitted
3/04/2020
Date registered
4/05/2020
Date last updated
4/05/2020
Date data sharing statement initially provided
4/05/2020
Date results information initially provided
4/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasogastric tube Placement under Sonographic Observation: a comparison study of ultrasound and chest radiograph in mechanically ventilated patients
Scientific title
Nasogastric tube Placement under Sonographic Observation: a comparison study of ultrasound and chest radiograph in mechanically ventilated patients
Secondary ID [1] 300938 0
Wishlist Organisation reference 2014-16
Universal Trial Number (UTN)
Trial acronym
NaPSO
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Critical Care patients 316937 0
mechanically ventilated patients 316938 0
patients requiring enteral feeding 316939 0
Condition category
Condition code
Other 315101 315101 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound of the neck and stomach in transverse and longitudinal planes of a patient who has an existing Nasogastric tube. This will be done in order to compare against a chest x-ray to assess accuracy of ultrasound nasogastric tube position verification. This will be done by Medical Officers (Registrar) with 6 months intensive care experience. Medical officers will have a powerpoint presentation outlining protocol and the procedure. The medical officers will also be supervised for their technique and adherence to protocol and deemed competent to commence enrollment by a senior consultant or primary investigator. This intervention will be performed face to face with the patient with the registered nurse present. The intervention will be performed a maximum on two times for a duration of under 10 minutes unless patient deterioration takes priority. The intervention will take place in the Intensive Care Unit bedspace that the patient is allocated to. The intervention will not be personalised, adapted or titrated to any groups of individuals. The intervention adherence will be recorded on a data collection form which will highlight nasogastric tube type, size, insertion depth, consent gained, inclusion criteria met, exclusion criteria assessed, and study findings. Images taken with the ultrasound machine are re-identifiable. Consultants will be available to assist at all times with any concerns or quarries. Registrars will have access to resources and materials required such as protocols and fact sheets.
All nasogastric tubes will be radiologically verified before use as per hospital policy.
Intervention code [1] 317253 0
Treatment: Devices
Comparator / control treatment
The control is standard chest x-ray.
The timing of the x-ray is preferably done post ultrasound scan of the nasogastric tube. In the case that the x-ray has been performed the Medical Officer must be unaware that an x-ray has been done.
The x-ray is then ordered by the Medical Officer and carried out by the radiologist.
The Medical Officer then can examine the x-ray for nasogastric tube placement.
Control group
Active

Outcomes
Primary outcome [1] 323387 0
Percentage of ultrasound scans correctly identifying the NGT in the oesophagus and epigastrium when compared with chest x-ray
Timepoint [1] 323387 0
Prior to use of the nasogastric tube
Secondary outcome [1] 381767 0
The effectiveness of a non radiologist ultrasound scan of a nasogastric tube will be assessed with the use of chest radiograph.
The chest radiograph will assess the position of the nasogastric tube position for comparison against ultrasound findings.
Timepoint [1] 381767 0
prior to chest x-ray confirmation

Eligibility
Key inclusion criteria
Admitted to the Intensive Care Unit requiring endotracheal intubation/ mechanical ventilation and a nasogastric tube for the treatment or diagnosis of their admitting illness
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
head injury/base of skull fracture, severe facial fracture, recent nasal surgery, body mass index above 35, coagulopathy, cervical spine collar, history of gastrectomy or surgery of the gastro oesophageal junction, recent surgery involving a laparotomy, abdominal trauma, intestinal perforation, oesophageal varices, strictures, trauma, tumour or pregnancy

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
Safety/efficacy
Statistical methods / analysis
Convenience sample sizing. Total number of participants 25 .
Statistical analysis using STATA (v15.0). Shapiro Wilk test for normality. Numerical values are expressed as means ± standard deviation. Categorical variables are expressed as number (n) and percent (%). Sensitivity, positive predictive value (PPV) and negative predictive value (NPV) is calculated for both oesophagus and stomach findings.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
19/07/2016
Date of last participant enrolment
Anticipated
Actual
1/10/2019
Date of last data collection
Anticipated
Actual
1/10/2019
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16342 0
Nambour General Hospital - Nambour
Recruitment hospital [2] 16343 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 29886 0
4560 - Nambour
Recruitment postcode(s) [2] 29887 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 305382 0
Charities/Societies/Foundations
Name [1] 305382 0
Wishlist Organisation
Country [1] 305382 0
Australia
Primary sponsor type
Individual
Name
Carena McMullen
Address
Wishlist Organisation
Sunshine Coast University Hospital
6 Doherty street, Birtinya
Sunshine Coast, 4575
Queensland, Australia
Country
Australia
Secondary sponsor category [1] 305920 0
None
Name [1] 305920 0
Address [1] 305920 0
Country [1] 305920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305713 0
Royal Brisbane Woman's Hospital Ethics committee
Ethics committee address [1] 305713 0
Metro North Hospital and Health Service
Public Health Department
Royal Brisbane and Women's Hospital
7 Butterfield Street
Herston
QLD 4029
Ethics committee country [1] 305713 0
Australia
Date submitted for ethics approval [1] 305713 0
22/12/2014
Approval date [1] 305713 0
09/01/2015
Ethics approval number [1] 305713 0
HREC/14/QRBW/282

Summary
Brief summary
The objective of this study is to examine the diagnostic accuracy of ultrasound (US) scanning of the nasogastric tube (NGT) in mechanically ventilated patients by non radiologist. The study design is a dual centre prospective, single blind study assessing US of the NGT with positive placement verification being a captured hyperechoic image of an NGT in the oesophagus and epigastrium. This is compared to the chest radiograph. The setting will consist of patients admitted to the intensive care unit (ICU) who were mechanically ventilated and required a nasogastric tube for either the treatment or diagnosis of their admitting illness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101318 0
Miss Carena McMullen
Address 101318 0
Sunshine Coast University Hospital
Department of Intensive Care
6 Doherty Street
Birtinya 4575
Sunshine Coast
Queensland, Australia
Country 101318 0
Australia
Phone 101318 0
+61 420577776
Fax 101318 0
Email 101318 0
carena.mcmullen@health.qld.gov.au
Contact person for public queries
Name 101319 0
Miss Carena McMullen
Address 101319 0
Sunshine Coast University Hospital
Department of Intensive Care
6 Doherty Street
Birtinya 4575
Sunshine Coast
Queensland, Australia
Country 101319 0
Australia
Phone 101319 0
+61 420577776
Fax 101319 0
Email 101319 0
carena.mcmullen@health.qld.gov.au
Contact person for scientific queries
Name 101320 0
Miss Carena McMullen
Address 101320 0
Sunshine Coast University Hospital
Department of Intensive Care
6 Doherty Street
Birtinya 4575
Sunshine Coast
Queensland, Australia
Country 101320 0
Australia
Phone 101320 0
+61 420577776
Fax 101320 0
Email 101320 0
carena.mcmullen@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data collection forms.
Nasogastric type, size insertion depth
if the nasogastric tube was visible on ultrasound in the neck or stomach
medical officer comments
When will data be available (start and end dates)?
03/04/2020 - 03/04/2021
Available to whom?
On request, researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Methodology could include quantitative or qualitative prospective studies including data collection related to nasogastric tube placement verification.
How or where can data be obtained?
access subject to approvals by Principal Investigator
carena.mcmullen@health.qld.gov.au


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.