ANZCTR - Registration

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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

nasogastric tube position

Condition category

Condition code

Diet and Nutrition

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]

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]

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]

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]

nil

Timepoint [1]

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?

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]

Government body

Name [1]

The Alfred Felton Bequest

Address [1]

ANZ Trustees Limited
Level 4, 100 Queen St Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Nutricia

Address [2]

12-24 Talavera Rd
Macquarie Park NSW 2113

Country [2]

Australia

Primary sponsor type

Hospital

Name

Murdoch Children's Research Institute

Address

Flemington Rd
Parkville VIC 3052

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Royal Children's Hospital

Address [1]

Dept of Nutrition and Food Services
Flemington Rd
Parkville VIC 3052

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics in Human Research Committee

Ethics committee address [1]

Murdoch Children's Research Institute (MCRI)
Royal Children's Hospital
Flemington Rd
PArkville VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/04/2006

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Heather Gilbertson

Address

Department of Nutrition and Food Services
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

613 9345 5663

Fax

613 9345 6496

heather.gilbertson@rch.org.au

Contact person for scientific queries

Name

Heather Gilbertson

Address

Department of Nutrition and Food Services
Royal Children's Hospital
Flemington Rd
Parkville VIC 3052

Country

Australia

Phone

613 9345 5663

Fax

613 9345 6496

heather.gilbertson@rch.org.au

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.

Trial Review

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