Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT02609620
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02609620
Study Brief:
Protocol Section:
NCT02609620