Internal Tube Length of the Nasogastric Tube

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05557396
Collaborator
(none)
155
1
5
12
12.9

Study Details

Study Description

Brief 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.

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Internal Tube Length Measurement Procedures for Nazogastric Tube
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
The Efficiency of Internal Tube Length Measurement Methods in Correct Placement of the Nasogastric Tube
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

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

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Adnan Menderes University Aydın Turkey

Sponsors and Collaborators

  • Aydin Adnan Menderes University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nihal Taskiran, Principal Investigator, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier:
NCT05557396
Other Study ID Numbers:
  • nasogastric tube
First Posted:
Sep 28, 2022
Last Update Posted:
Oct 3, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nihal Taskiran, Principal Investigator, Aydin Adnan Menderes University

Study Results

No Results Posted as of Oct 3, 2022