Functionality and Accuracy of the smART System in Real-Life ICU Settings

ART Medical

Status

Terminated

Conditions

Aspiration Pneumonia

Treatments

Device: smART Feeding Tube System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03198988

CLT3_SY_P001

Details and patient eligibility

About

Total participants in the "Functionality and Accuracy of the smART System in Real-Life ICU Settings" are 10 participants - in the current Jefferson study site there were 8 participants and in the Sheba study site (identifier NCT03689985) there were 2 participants.

This study is conducted in order to validate the functionality and accuracy of the smART™ System in a real-life ICU setting. The smART™ Feeding Tube System is a novel system with nasogastric tube developed by ART Medical (Healthcare) Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smART™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smART™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smART™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smART™ Feeding Tube System can guide operator to correctly re-position the tube. Lastly the smART™ Feeding Tube System is equipped with an anti-reflux mechanism and automatic Gastric Residual Volume (GRV).

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and females 18 years or older
Patient has already been admitted to ICU
Patient requires enteral feeding
Patients receiving Proton Pump Inhibitors (PPI) therapy
Informed consent by independent physician and next of kin
ICU ventilated patients

Exclusion criteria

Patients with anomalies or diseases of the esophagus and or stomach.
Patients with known sensitivities or allergies to any of the feeding tube materials
Inability to place patient in semi-Fowler's position.
Any clinically significant abnormality upon physical examination which may, in the opinion of the investigator, pose difficulty in inserting the feeding tube (e.g. cervical spine disorder)
Pregnancy
Recent abdominal surgery (less than 30 days)