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

Phase 2

Completed

• Conditions: Intubation, Nasogastric
• Interventions: Device: NG Shield

• Registration Number: NCT00781248
• Lead Sponsor: Nanovibronix

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-26
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-28
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Subject is in good health and able to undergoes the NG tube insertion procedure, according to the PI decision
2. Subject is able to understand and answer the pain and discomfort questionnaires
3. Subject has been fasting for at least 12h prior to the insertion phase
4. Subject underwent a physical examination by the PI
5. Subject able, agrees and signs the Inform Consent Form (ICF)

Exclusion Criteria

1. Subject has any history of dysphagia or esophageal disease
2. Subject used anti pain medications during the last week prior to the study date
3. Subject used Antibiotics during the last week prior to the study date
4. Subject with Asthma
5. Subject with chronic or acute nasal or throat disorder
6. Subject who suffered from upper respiratory infection at least 7 days prior to the insertion procedure
7. Any pain from other source prior to the initiation of the study procedure according to the PI judgment and decision
8. Subject has any condition, which precludes compliance with study and/or device instruction for use
9. Subject is currently participating in another clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	NG Shield	Starting with inactive NG Shield
1	NG Shield	starting with active NG Shield

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
pain/Dicomfort during insertion and removal of the nasogastric tube	at t=0h and t=6h

Trial Locations

Locations (1)

"Bikur Cholim" Hospital; 🇮🇱 Jerusalem, Israel