Internal Tube Length of the Nasogastric Tube

June 20, 2024 updated by: Nihal Taskiran, Aydin Adnan Menderes University

The Efficiency of Internal Tube Length Measurement Methods in Correct Placement of the Nasogastric Tube

This methodological research is aimed to examine the effectiveness of the methods used to estimate the internal length of the nasogastric tube and to determine the most reliable method for correct placement of the nasogastric tube in adults.

The study will be carried out between 01 September 2022 and 01 September 2023 with 155 patients who hospitalized in the anesthesia and reamination intensive care and general intensive care units of Aydın Adnan Menderes University Application and Research Hospital.

The internal tube length measurement methodologies will utilized to confirm proper NGT placement. A total of 5 groups will be included in the study, including 1 control (NEX measurement method) and 4 experimental groups, (Experiment 1: CoNEX measurement method, Experiment 2: XEN+10 cm measurement method, Experiment 3: GWNUF measurement method, Experiment 4: EXU-NE Method measurement method).The "gold standard" reference method will used for comparison was radiography.

Research data will be analyzed in SPSS (Statistical Package for Social Sciences) for Windows 25.0 statistical package program. Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of the data. The comparison between the methods used in the measurement of the nasogastric tube (NEX, CoNEX, XEN+10 cm, GWNUF, EXU-NE) and the results of the radiological evaluation (reference method) will be made with Chi-square analysis. Statistical significance will be accepted as p<0.05.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This research is a methodological study in a single-blind randomized controlled experimental model. This research is aimed to examine the effectiveness of the methods used to estimate the internal length of the nasogastric tube and to determine the most reliable method for correct placement of the nasogastric tube in adults.

The study will be carried out between September 2022-September 2023 with 155 patients who hospitalized in the anesthesia and reamination intensive care and general intensive care units of Aydın Adnan Menderes University Application and Research Hospital.

A total of five internal tube length measurement methodologies will utilized to determine the length of NGT to be placed on the patient. These methods are CoNEX measurement method (Experiment 1), XEN+10 cm measurement method (Experiment 2), GWNUF measurement method (Experiment 3), EXU-NE Method measurement method (Experiment 4) and NEX measurement method (control). To collect data, a ''Case Report Form'' is carried out. This form consisted of 17 items regarding each patient's descriptive characteristics (age, gender, etc.), data concerning their illness and treatment (duration in intensive care, medical diagnosis, existing chronic disease, level of consciousness, drugs being administered) as well as data about the NGT intubation (type and gauge of NGT, observation for signs of respiratory distress, other complications, etc.).Patient information will obtained from their medical records. All the NGT placements will conducted by the same researcher under the supervision of the other two researchers. Following NGT insertion, "abdominal x-ray"(gold standard)" reference method will used to confirm the placement of NGT.

Descriptive statistical methods (number, percentage, mean, standard deviation) will be used in the evaluation of the data. The comparison between the methods used in the measurement of the nasogastric tube (NEX, CoNEX, XEN+10 cm, GWNUF, EXU-NE) and the results of the radiological evaluation (reference method) will be made with Chi-square analysis. Statistical significance will be accepted as p<0.05.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Aydın, Turkey
        • Adnan Menderes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • >18 age,
  • Being a patient in the adult intensive care units of the hospital where the research was conducted,
  • Glasgow coma scale ≤8,

Exclusion Criteria:

  • Patients fed through orogastric, orojejunal, gastrostomy, jegenostomy, and ostomy,
  • Patients who are pregnant or suspected of pregnancy,
  • Patients presenting with a history of trauma,
  • Patients with esophageal varices, nasal septal deviation, upper respiratory tract and/or digestive system anomalies,
  • Patients who had a nasogastric tube inserted or whose nasogastric tube would be changed before participating in the study,
  • Patients whose nose-earlobe-xiphoid distance cannot be measured,
  • Patients who are not accepted to participate in the study by their legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NEX (Control group)

Nose-ear-xiphoid measurement method (NEX), (n=31)

The distance between the patient's nose tip and earlobe will be measured first, then the distance between the earlobe and the xiphoid (NEX method) Marking will be made on the nasogastric tube according to the length obtained from the measurement, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.
Experimental: CoNEX
Corrected nose-earlobe-xiphoid measurement method (CoNEX), (n=31) The distance between the patient's nose tip and earlobe will be measured first, and then the distance between the earlobe and the xiphoid, The nasogastric tube length to be applied to the patient will be determined according to the formula (NEX x 0.38696) + 36.37 cm, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.
Experimental: XEN+10

Xiphoid-earlobe-nose+10 cm (XEN+10), (n=31)

The distance between the patient's xiphoid and earlobe will be measured first, and then the distance between the earlobe and the tip of the nose will be measured and 10 cm will be added to the obtained measurement, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.
Experimental: GWNUF

Gender-weight-nose-umblikus-head flat (GWNUF), (n=31)

The patient's body weight will be measured without clothes on, When the patient is in the supine position, the distance between the tip of the nose and the umbilicus will be measured, The length of the nasogastric tube to be applied to the patient according to the formula 29.38 + (4.53 x gender) + (0.34 x distance between the tip of the nose and the umbilicus) - (0.06 x patient weight), (gender = 1 for male patient, 0 for female patient) to be determined, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the insertion procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.
Experimental: EXU-NE
The distance between the patient's xiphoid and earlobe will be measured first (Measurement 1), (n=31) The distance between the patient's xiphoid and the midline of the umbilicus will be measured (Measurement 2), The two obtained measurement values will be added (Measurement 1 + Measurement 2), The distance between the patient's nose tip and earlobe will be measured (Measurement 3), Measurement 3 value will be subtracted from the sum of Measurement 1 and Measurement 2 values, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the insertion procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The CoNEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
Time Frame: One year
By creating a straight line with a tape measure, first the distance between the patient's nose tip and the earlobe and then the distance between the earlobe and the xiphoid will be measured, then the nasogastric tube length to be applied to the patient will be determined according to the (NEX x 0.38696) + 36.37 cm formula. The length determined according to the result will be marked on the nasogastric tube, and the nasogastric tube will be advanced by the researcher from the patient's nose to the marked place.Immediately after the completion of the insertion process, an abdominal X-ray will be taken and the tube location will be confirmed.
One year
The XEN+10 cm method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
Time Frame: one year
By creating a straight line with a tape measure, the distance between the patient's xiphoid and earlobe, then the distance between the earlobe and the tip of the nose will be measured and 10 cm will be added to the measurement obtained. The location of the tube will be confirmed by taking an abdominal x-ray immediately after the placement process is completed, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
one year
The GWNUF method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
Time Frame: one year
Body weight will be measured without clothing on the patient, The distance between the tip of the nose and the umbilicus will be measured while the patient is in the supine position, 29.38 + (4.53 x gender) + (0.34 x distance between the tip of the nose and the umbilicus) - (0.06 x patient weight), (gender) The length of the nasogastric tube to be applied to the patient will be determined according to the formula = 1 for male patient, 0 for female patient, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the investigator from the patient's nose to the marked area, Immediately after the completion of the insertion procedure, the abdominal X-ray will be determined. The tube location will be confirmed by filming, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
one year
EXU-NE method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
Time Frame: One year
By creating a straight line with a tape measure, the distance between the patient's xiphoid and earlobe will be measured first (Measurement 1), The distance between the patient's xiphoid and the midline of the umbilicus will be measured (Measure 2), The two obtained measurement values will be added (Measurement 1 + Measurement 2), The distance between the patient's nose tip and earlobe will be measured (Measurement 3), Measurement 3 value will be subtracted from the sum of Measurement 1 and Measurement 2 values, The length determined according to the result obtained will be marked on the nasogastric tube, The nasogastric tube will be advanced by the researcher from the patient's nose to the marked place, Insertion Immediately after the completion of the procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
One year
The NEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
Time Frame: One year
By creating a straight line with a tape measure, first the distance between the patient's nose tip and the earlobe and then the distance between the earlobe and the xiphoid will be measured, A marking will be made on the nasogastric tube according to the length obtained from the measurement, The nasogastric tube will be advanced by the researcher from the patient's nose to the point where the marking is made, Immediately after the completion of the nasogastric tube placement procedure, an abdominal X-ray will be taken to confirm the tube location, the position of the distal end of the tube relative to the gastro-esophageal junction will be measured and recorded.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Investigators

  • Principal Investigator: Nihal Taskiran, PhD, Aydin Adnan Menderes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 23, 2022

First Submitted That Met QC Criteria

September 23, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • nasogastric tube

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Nihal Taskiran-study protocol Pakize Özçiftçi Yılmaz-informed consest form Dilek Sarı-Statistical analysis plan Tuna Şahin_study protocol Necla Olcum- informed consent form

IPD Sharing Time Frame

one year

IPD Sharing Access Criteria

Reaching the target sample size

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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