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This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER.
Enterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.
The PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | In the treatment group: The LunGuard Peristaltic Feeding Tube (PFT) will be positioned in the ICU and positioning will be verified by X-ray. Nutritional formula will be fed into the stomach via the feeding lumen of the PFT |
|
| Control | Active Comparator | Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peristaltic Feeding Tube | Device |
| ||
| ConvaTec Levin Duodenal Tube |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of gastro-esophageal reflux (GER) by 30% | 12-24 hours | |
| Continuous esophageal pressure monitoring | 12-24 hours | |
| Successful introduction, positioning and removal of the device | 12-24 h | |
| Successful enteral feeding | 12-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of ventilator associated pneumonia (VAP) | 12-24 hours | |
| Reduction of micro-aspirations | 12-24 hours |
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Inclusion Criteria:
Informed consent.
Patients who are expected for at least 12 hours to be:
Included are:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adi Ickowicz | Contact | +97239233666 | 0 | adi@medicsense.com |
| Gilat Mor | Contact | +97239233666 | 4 | gilat@medicasense.com |
| Name | Affiliation | Role |
|---|---|---|
| Philip Biderman, MD | Bellinson Hospital | Principal Investigator |
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|
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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