Condition category
Respiratory
Date applied
31/10/2017
Date assigned
03/11/2017
Last edited
01/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The placing of nasogastric feeding tubes is a worldwide nursing technique. The correct tip position inside the stomach is essential to administer safe tubefeeding to avoid serious complications that can even cause death. Till now the distance between the nose-ear-xiphoid distance (NEX) still appears to be the gold standard to determine the insertion length of a nasogastric tube. Various studies have already demonstrated that this method is not reliable and suggestions were made for new methods, including the Hanson’s formula corrected NEX distance (1979). The aim of this study is to determine whether Hanson’s formula corrected NEX distance results in a higher number of correctly placed nasogastric tubes in adults who have a medical need for nasogastric tube placement/tube feeding compared to the NEX distance. The likelihood in obtaining gastric content between both methods after placement of the nasogastric tube will also be studied because this is an important control mechanism to check a correct placement of de tube inside the stomach (and not in the lungs).

Who can participate?
Adults aged 18 and older who have a need for nasogastric tube placement/tube feeding.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group have the external length determination of the nasogastric tubes performed using the nose-ear-xiphoid distance. Those in the second group have the external length determination is performed using the Hanson’s formula corrected nose-ear-xiphoid distance. In both groups it is attempted to obtain gastric aspirate immediately after placement of the nasogastric tube.

What are the possible benefits and risks of participating?
The findings from this study may help researchers to develop a new easy clinically feasible method for external length determination of nasogastric tubes that contributes to a safer and more efficient placement procedure. Participation in this study does not result in a higher risk of complications due to the intervention compared to other patients who should receive the same intervention during their therapy outside this study.

Where is the study run from?
General Hospital AZ Nikolaas (Belgium)

When is the study starting and how long is it expected to run for?
Septembe 2015 to December 2017

Who is funding the study?
Odisee University College (Belgium)

Who is the main contact?
Mr Tim Torsy
tim.torsy@odisee.be

Trial website

https://praktijkgerichtonderzoek.odisee.be/?q=projecten/correcte-lengtebepaling-van-nasogastrische-voedingssondes-bij-meerderjarige-patienten-op

Contact information

Type

Public

Primary contact

Mr Tim Torsy

ORCID ID

Contact details

Odisee University College
Campus Waas
Hospitaalstraat 23
Sint-Niklaas
9100
Belgium
+32 495 143 557
tim.torsy@odisee.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OCOOR Onderzoek P0139 Nasogastrisch

Study information

Scientific title

Does the Hanson’s formula corrected nose-ear-xiphoid (NEX) distance results in a higher number of correctly placed nasogastric tubes in hospitalized adults compared to the nose-ear-xiphoid distance (NEX)

Acronym

Study hypothesis

The Hanson’s formula corrected nose-ear-xiphoid distance results in a higher amount of correctly placed nasogastric tubes with greater probability in obtaining gastric aspirate compared to the nose-ear-xiphoid distance.

Ethics approval

Review Committee for Medical Ethics from AZ Nikolaas, 12/11/2015, ref: EC15053

Study design

Blinded prospective randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

This study is conducted in the field of nursing and healthcare in patients with a medical indication for nasogastric tube placement.

Intervention

Participants are randomised to either the control or intervention group by using block randomisation. In the control group external length determination of the nasogastric tubes is performed using the nose-ear-xiphoid distance. In the intervention group external length determination is performed using the Hanson’s formula corrected nose-ear-xiphoid distance. In both groups it is attempted to obtain gastric aspirate immediately after placement of the nasogastric tube.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. The tip position of the nasogastric tube inside the stomach is measured using the technique of X-ray (chest X-ray images) at the moment immediately after inserting/repositioning of the tube
2. The obtainment of gastric aspirate after insertion of the nasogastric tube is measured using a syringe (60 ml) with a conical end and pH indicator strips with a colour 0.5 pH units scale at a time lapse of 1 hour after placement/reposition of the tube

Secondary outcome measures

The association between the study group and the outcome (controlled for age, gender, body length, and cognitive awareness) is measured using a multivariate binary logistic regression analysis at time of data-analysis.

Overall trial start date

16/09/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult (male/female) >= 18 years
2. Medical indication for nasogastric tube feeding/nasogastric tube placement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Xiphoid not palpable
2. Documented surgical or anatomically abnormalities of the oesophagus or stomach
3. Not able or unwilling to sign the written informed consent

Recruitment start date

01/12/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Belgium

Trial participating centre

General Hospital AZ Nikolaas
Moerlandstraat 1
Sint-Niklaas
9100
Belgium

Sponsor information

Organisation

Odisee University College

Sponsor details

Research departement
Warmoesberg 26
Brussels
1000
Belgium

Sponsor type

University/education

Website

https://www.odisee.be/en/

Funders

Funder type

University/education

Funder name

Odisee University College

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Based on the results of the study, we are planning to write an article for Clinical Nutrition, the official journal of the European Society for Clinical Nutrition and Metabolism (ESPEN). The digital versions of the study protocol, intervention procedures and statistical analysis plan (written in Dutch) are available on request by email (tim.torsy@odisee.be) or by phone (+32495143557).

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/03/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes