Clinical trial NCT05557396: Internal Tube Length of the Nasogastric Tube
Official title: The Efficiency of Internal Tube Length Measurement Methods in Correct Placement of the Nasogastric Tube
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Feeding Tube Complication
Keywords: nasogastric tube
internal tube length
critical care
nursing
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The CoNEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
timeFrame: One year
measure: The XEN+10 cm method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
timeFrame: one year
measure: The GWNUF method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
timeFrame: one year
measure: EXU-NE method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
timeFrame: One year
measure: The NEX method is an effective measurement method to accurately determine the internal length of the nasogastric tube.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University
Study officials:
affiliation: Aydin Adnan Menderes University
name: Nihal Taskiran, PhD
role: PRINCIPAL_INVESTIGATOR
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