Gastro-esophageal Reflux Clinical Trial
— PFTOfficial title:
A Single-Center, Open Label, Randomized, Controlled Study to Evaluate the Safety & Initial Efficacy of the LunGuard PFT System, and Its Impact on GER in Enteral-Fed, Sedated and Mechanically Ventilated Critically Ill Patients
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.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | October 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Informed consent. - Patients who are expected for at least 12 hours to be: - Mechanically ventilated and sedated. - Requiring a nasogastric tube. - Included are: - Patients who have undergone tracheostomy. - Patients who require use of pro-kinetic drugs and proton pump inhibitors. - All levels of Gastric Residual Volume (GRV) Exclusion Criteria: - • Patients with a contraindication for insertion of a nasogastric tube. - Patients with a known esophageal obstruction, preventing passage of the device. - Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients) - Acute and severe coagulation disorders - (INR> 2 or platelets below 30,000) - Diabetic patients with documented gastrointestinal neuropathy - Pregnancy or lactation - Allergy to Silicon - Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
LunGuard Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of gastro-esophageal reflux (GER) by 30% | 12-24 hours | No | |
Primary | Continuous esophageal pressure monitoring | 12-24 hours | Yes | |
Primary | Successful introduction, positioning and removal of the device | 12-24 h | Yes | |
Primary | Successful enteral feeding | 12-24 hours | Yes | |
Secondary | Reduction of ventilator associated pneumonia (VAP) | 12-24 hours | No | |
Secondary | Reduction of micro-aspirations | 12-24 hours | No |
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