EVALUATION OF SAFETY AND EFFICACY OF THE NG-SHIELD IN HEALTHY SUBJECTS WITH INDWELLING NASOGASTRIC TUBE
NasoGastric (NG) tube use is commonly associated with nasal and pharyngeal pain and discomfort secondary to trauma caused by the tube to the nasal and pharyngeal tissues. We tested the NG-Shield device that is designed to decrease NG associated pain and discomfort as well as tube associated trauma, in normal healthy volunteers.
This is a crossover, double blind, controlled randomized study.
24 healthy volunteers were recruited for the study.
The overall plan for all subjects consisted of the following elements:
- Subjects were assessed for their eligibility to participate in the study according to the inclusions/exclusions criteria and signed an informed consent according to Declaration of Helsinki and local regulations
- Randomization procedure was performed to determine the order of the devices during the study
- Activation of the NG Shield (if required, according to the randomization)
- Insertion of the NG tube
- Assessment of the insertion procedure
- Pain and discomfort assessment (every 30 minutes)
- Changing NG Shield status (active or inactive) every 60 minutes
- Removal of the NG tube (at t = 6 hours)
- Assessment of the removal procedure
- Physical examination of the subject
- Study termination
This study is aimed to assess the safety and effectiveness of the NG Shield in healthy subjects who undergo Nasogastric tube insertion.
To assess the safety of the NG Shield with indwelling NG tube Efficacy objectives
- To facilitate insertion and removal of the NG tube
- To reduce the pain due to presence of NG tube in the body
To reduce the discomfort level due to presence of NG tube in the body
Physical and clinical parameters
Table 1 summarizes the clinical parameters of the study groups. The results demonstrates that the groups are similar with no statistical differences
Pain and discomfort levels during the Insertion and removal of NG tube
The pain and discomfort levels that were recorded during the introduction and removal of the NG tube demonstrated that there was no difference in NG Tube passage or removal between the groups
Pain and discomfort levels during the indwelling NG tube
The results in the indwelling phase revealed that when starting with an inactive device a reduction of 55%, 36% and 32% in the nasal discomfort level and 24%, 33% and 22% in the pharyngeal discomfort level was present within the 1st, 2nd and 3rd crossover periods respectively (Graph 1)
The Surface Acoustic Technology employed by NG Shield and the resultant decrease in static friction of the NG tube reduced NG tube related symptoms in this study. This is the first medical device or therapy directed to reduce pain and discomfort induced by an indwelling nasogastric tube. In addition, it could possibly be utilized to treat or reduce NG tube related injury.