Safety and Efficacy Study of the NG Shield, a Device Intended to Reduce Pain and Discomfort Level Related to Nasogasstric Tube Usage

Study Overview
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Brief Summary
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The purpose of the study i to demonstrate the safety and efficacy of a device that intends to reduce pain/discomfort related to nasogfastric tube usage by reducing the friction between the tube and internal orifice (nose and pharynx)using micro vibrations

Official Title
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Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube

Conditions
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Intubation, Nasogastric

Intervention / Treatment
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* Device: NG Shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision Subject is able to understand and answer the pain and discomfort questionnaires Subject has been fasting for at least 12h prior to the insertion phase Subject underwent a physical examination by the PI Subject able, agrees and signs the Inform Consent Form (ICF) Exclusion Criteria: Subject has any history of dysphagia or esophageal disease Subject used anti pain medications during the last week prior to the study date Subject used Antibiotics during the last week prior to the study date Subject with Asthma Subject with chronic or acute nasal or throat disorder Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision Subject has any condition, which precludes compliance with study and/or device instruction for use Subject is currently participating in another clinical study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>starting with active NG Shield | Device: NG Shield<br>* A device to reduce pain/discomfort related to nasogastric tube usage<br>|
| Experimental: 2<br>Starting with inactive NG Shield | Device: NG Shield<br>* A device to reduce pain/discomfort related to nasogastric tube usage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase |  | every 30 minutes for 6 hours | 
| safety of device usage |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain/Dicomfort during insertion and removal of the nasogastric tube |  | at t=0h and t=6h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enteral feeding, Subject who requires nasogastric tube