Intubation, Nasogastric Clinical Trial
Official title:
Evaluation of Safety and Efficacy of the NasoGastric Shield (NG Shield) in Healthy Subjects With Indwelling Nasogastric Tube
| Verified date | March 2009 |
| Source | Nanovibronix |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | December 2008 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Israel | "Bikur Cholim" Hospital | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Nanovibronix |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain/discomfort levelusing flicker scale (1-10 scale)during indwelling phase | every 30 minutes for 6 hours | No | |
| Primary | safety of device usage | 6 hours | Yes | |
| Secondary | pain/Dicomfort during insertion and removal of the nasogastric tube | at t=0h and t=6h | No |