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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02609620
Other study ID # PROT-150630835CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 17, 2015
Last updated December 30, 2015
Start date December 2015
Est. completion date October 2016

Study information

Verified date December 2015
Source LunGuard Ltd.
Contact Adi Ickowicz
Phone +97239233666
Email adi@medicsense.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Peristaltic Feeding Tube

ConvaTec Levin Duodenal Tube


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
LunGuard Ltd.

Outcome

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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