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Trial registered on ANZCTR


Registration number
ACTRN12609000876291
Ethics application status
Approved
Date submitted
16/09/2009
Date registered
7/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
To determine a practical pH cutoff level for safer confirmation of nasogastric tube placement
Scientific title
To determine a more practical pH cutoff level than pH<4 for safer confirmation of nasogastric tube placement in children without increasing the risk of not identifying a misplaced tube in the lung.
Universal Trial Number (UTN)
U1111-1111-8403
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pH testing 243835 0
nasogastric tube position 243836 0
Condition category
Condition code
Diet and Nutrition 240010 240010 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To directly compare pH results of gastric aspirate samples in children receiving enteral feeding with endotracheal aspirate samples in children in intensive care requiring tracheal suctioning over a 6 month period. Particularly to examine potential overlap of pH results between the aspirate samples which is where the cutoff for identification of a misplaced tube would occur. This data can then be used to establish a reliable and clinically practical pH cut-off value for gastric aspirate without risking the safety of the patient by not identifying a misplaced nasogastric tube (NGT) in the lung.
Intervention code [1] 241290 0
Not applicable
Comparator / control treatment
All paediatric intensive care unit (PICU) patients within this age range who required endotracheal suctioning as part of their routine care were recruited to obtain endotracheal aspirate samples for pH testing over a 6 month period
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240925 0
We compare the range of pH results between gastric and endotrachael aspirate samples, with particular interest in the area of overlap between the two samples. This data will help to determine a reliable and practical pH value to confirm NGT placement, without increasing the risk of not identifying a misplaced NGT.
Timepoint [1] 240925 0
Gastric aspirate samples taken prior to administration of enteral feed (minimum once per day to maximum 2 hourly) until NGT is removed over the 6 month period.
Endotracheal aspirate samples collected at every tracheal suctioning procedure for patients in ICU (minimum once per day to maximum 2 hourly) until tracheal suctioning is no longer required as routine care over the 6 month period.
Secondary outcome [1] 257644 0
nil
Timepoint [1] 257644 0
nil

Eligibility
Key inclusion criteria
All patients aged over 4 weeks at the Royal Children's Hospital (RCH) receiving enteral nutrition (nasogastric or gastrostomy) were recruited to the study. In addition, all paediatric intensive care unit (PICU) patients within this age range who required endotracheal suctioning as part of their routine care were also recruited to obtain endotracheal aspirate samples for pH testing.
Minimum age
4 Weeks
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
less than 4 weeks of age

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
670
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243736 0
Government body
Name [1] 243736 0
The Alfred Felton Bequest
Country [1] 243736 0
Australia
Funding source category [2] 243737 0
Commercial sector/Industry
Name [2] 243737 0
Nutricia
Country [2] 243737 0
Australia
Primary sponsor type
Hospital
Name
Murdoch Children's Research Institute
Address
Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 237098 0
Hospital
Name [1] 237098 0
Royal Children's Hospital
Address [1] 237098 0
Dept of Nutrition and Food Services
Flemington Rd
Parkville VIC 3052
Country [1] 237098 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243873 0
Ethics in Human Research Committee
Ethics committee address [1] 243873 0
Murdoch Children's Research Institute (MCRI)
Royal Children's Hospital
Flemington Rd
PArkville VIC 3052
Ethics committee country [1] 243873 0
Australia
Date submitted for ethics approval [1] 243873 0
Approval date [1] 243873 0
04/04/2006
Ethics approval number [1] 243873 0
EHRC 25101A

Summary
Brief summary
Confirmation of correct nasogastric tube (NGT) placement is essential to ensure the safe delivery of nutrition without the risk of morbidity and mortality associated with misplacement in the lung resulting in aspiration, pneumonia, pneumothorax or death. Previous studies indicate a pH < 4 is indicative of gastric aspirate and hence a reliable indicator of correct NGT placement. At the Royal Children’s Hospital (RCH) in Melbourne, the current practice is to use this pH cut-off < 4 based on Metheny’s work, but this is not always clinically practical. The use of antacid medication and/or the presence of enteral feeds due to delayed gastric emptying may be contributing factors in a higher pH result, casting doubt on NGT position. A number of different clinical methods have been reported to determine NGT position including auscultation (listening for air passed down the tube), aspirate colour, administering oral fluids or flushing NGT with oral rehydration solution (ORS), but none are evidence-based methods. Radiography confirmation is the gold standard but has limited application secondary to availability, cost and radiation exposure. This study was undertaken to directly compare pH results of gastric aspirate samples with endotracheal aspirate samples, and particularly to examine potential overlap of pH results between the aspirate samples. This data can then be used to establish a reliable and clinically practical pH cut-off value for gastric aspirate without risking the safety of the patient by not identifying a misplaced NGT in the lung. Whilst undertaking this study, an adverse nasogastric-feeding incident occurred in the UK which led to the formation of a working party to challenge the assumptions and rituals of NGT placement. An NGT algorithm was developed using a risk assessment approach to improve the safety of NGT fed children and increase the awareness of the risks to health care providers. Subsequently, the National Patient Safety Agency (NPSA) published an alert that accepted a pH cut-off <5.5 as being an acceptable risk. This was decided by expert opinion and consensus rather than the result of new clinical research. This current study will provide further evidence for this consensus statement and ensure that our recommendations are based on evidence-based practice and lead to reduced patient risk. We compare the range of pH results between gastric and endotrachael aspirate samples, with particular interest in the area of overlap between the two samples. This data will help to determine a reliable and practical pH value to confirm NGT placement, without increasing the risk of not identifying a misplaced NGT.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 30284 0
Address 30284 0
Country 30284 0
Phone 30284 0
Fax 30284 0
Email 30284 0
Contact person for public queries
Name 13531 0
Heather Gilbertson
Address 13531 0
Department of Nutrition and Food Services
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 13531 0
Australia
Phone 13531 0
613 9345 5663
Fax 13531 0
613 9345 6496
Email 13531 0
[email protected]
Contact person for scientific queries
Name 4459 0
Heather Gilbertson
Address 4459 0
Department of Nutrition and Food Services
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052
Country 4459 0
Australia
Phone 4459 0
613 9345 5663
Fax 4459 0
613 9345 6496
Email 4459 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
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Documents added automatically
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