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Feeding Tube ComplicationNCT05557396

Internal Tube Length of the Nasogastric Tube

A study testing Internal Tube Length Measurement Procedures for Nazogastric Tube in people with Feeding Tube Complication, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Feeding Tube Complication
What is being tested?
Internal Tube Length Measurement Procedures for Nazogastric Tube
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2022to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Adnan Menderes University

    Aydin

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Internal Tube Length Measurement Procedures for Nazogastric Tube
Keywords
nasogastric tube, internal tube length, critical care, nursing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internal Tube Length Measurement Procedures for Nazogastric TubeOther

    Different Internal Tube Length Measurement Procedures will used for the correct placement of nasogastric tube.

Study groups in NCT05557396
Study groupRoleWhat they receive
NEX (Control group)Active comparatorNose-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.
Receives: Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
CoNEXExperimentalCorrected 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.
Receives: Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
XEN+10ExperimentalXiphoid-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.
Receives: Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
GWNUFExperimentalGender-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.
Receives: Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
EXU-NEExperimentalThe 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.
Receives: Other: Internal Tube Length Measurement Procedures for Nazogastric Tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The CoNEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    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.

    Measured: One year

  2. The XEN+10 cm method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    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.

    Measured: one year

  3. The GWNUF method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    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.

    Measured: one year

  4. EXU-NE method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    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.

    Measured: One year

  5. The NEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.

    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.

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start1 Sep 2022
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Why it stopped: The targeted sample size could not be reached

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557396
Sponsor's protocol ID
nasogastric tube
Status last verified
Jun 2024
First submitted
23 Sep 2022
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Nihal Taskiran-study protocol Pakize Özçiftçi Yılmaz-informed consest form Dilek Sarı-Statistical analysis plan Tuna Şahin\_study protocol Necla Olcum- informed consent form

Publications

  • Chen YC, Wang LY, Chang YJ, Yang CP, Wu TJ, Lin FR, Liu SY, Wei TS. Potential risk of malposition of nasogastric tube using nose-ear-xiphoid measurement. PLoS One. 2014 Feb 10;9(2):e88046. doi: 10.1371/journal.pone.0088046. eCollection 2014.

    PubMed 24520344
  • Best C. How to insert a nasogastric tube and check gastric position at the bedside. Nurs Stand. 2016 May 18;30(38):36-40. doi: 10.7748/ns.30.38.36.s43.

    PubMed 27191450
  • Santos SC, Woith W, Freitas MI, Zeferino EB. Methods to determine the internal length of nasogastric feeding tubes: An integrative review. Int J Nurs Stud. 2016 Sep;61:95-103. doi: 10.1016/j.ijnurstu.2016.06.004. Epub 2016 Jun 15.

    PubMed 27328376
  • Ellett ML, Cohen MD, Perkins SM, Croffie JM, Lane KA, Austin JK. Comparing methods of determining insertion length for placing gastric tubes in children 1 month to 17 years of age. J Spec Pediatr Nurs. 2012 Jan;17(1):19-32. doi: 10.1111/j.1744-6155.2011.00302.x. Epub 2011 Sep 30.

    PubMed 22188269
  • Ellett ML, Beckstrand J, Flueckiger J, Perkins SM, Johnson CS. Predicting the insertion distance for placing gastric tubes. Clin Nurs Res. 2005 Feb;14(1):11-27; discussion 28-31. doi: 10.1177/1054773804270919.

    PubMed 15604226
  • Fan PEM, Tan SB, Farah GI, Cheok PG, Chock WT, Sutha W, Xu D, Chua W, Kwan XL, Li CL, Teo WQ, Ang SY. Adequacy of different measurement methods in determining nasogastric tube insertion lengths: An observational study. Int J Nurs Stud. 2019 Apr;92:73-78. doi: 10.1016/j.ijnurstu.2019.01.003. Epub 2019 Jan 14.

    PubMed 30743198
  • Malta MA, Carvalho-Junior AF, Andreollo NA, Freitas MI. [Anthropometric measures for the introduction of the nasogastric tube for enteral nutrition employing the esophagogastroduodenoscopy]. Arq Bras Cir Dig. 2013 Jun;26(2):107-11. doi: 10.1590/s0102-67202013000200007. Portuguese.

    PubMed 24000021
  • Taylor SJ, Allan K, McWilliam H, Toher D. Nasogastric tube depth: the 'NEX' guideline is incorrect. Br J Nurs. 2014 Jun 26-Jul 9;23(12):641-4. doi: 10.12968/bjon.2014.23.12.641.

    PubMed 25039627
  • Taylor SJ. Methods of Estimating Nasogastric Tube Length: All, Including "NEX," Are Unsafe. Nutr Clin Pract. 2020 Oct;35(5):864-870. doi: 10.1002/ncp.10497. Epub 2020 May 14.

    PubMed 32406552
  • Torsy T, Saman R, Boeykens K, Duysburgh I, Eriksson M, Verhaeghe S, Beeckman D. Accuracy of the corrected nose-earlobe-xiphoid distance formula for determining nasogastric feeding tube insertion length in intensive care unit patients: A prospective observational study. Int J Nurs Stud. 2020 Oct;110:103614. doi: 10.1016/j.ijnurstu.2020.103614. Epub 2020 May 11.

    PubMed 32702567
  • Torsy T, Saman R, Boeykens K, Duysburgh I, Van Damme N, Beeckman D. Comparison of Two Methods for Estimating the Tip Position of a Nasogastric Feeding Tube: A Randomized Controlled Trial. Nutr Clin Pract. 2018 Dec;33(6):843-850. doi: 10.1002/ncp.10112. Epub 2018 Jun 30.

    PubMed 29959848

Questions about this trial

What is this clinical trial studying?

A study testing Internal Tube Length Measurement Procedures for Nazogastric Tube in people with Feeding Tube Complication, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The CoNEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube. (time frame: One year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557396, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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