Clinical trial NCT03520582: Placement of Novel Endoscopic Enteral Feeding Tube
Official title: Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy Volunteers
Enteral Feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube

Brief summary: The aim of this study is to evaluate the technical feasibility of the new tube placement technology in healthy volunteers and, if proven feasible, in critically ill patients requiring placement of a feeding tube.

Detailed description: Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement especially in patients who are unable to fully collaborate during the tube placement due to neurological impairment and/or the presence of an artificial airway. The misplacement of a feeding tube in the airways has a high risk of severe complications, including pneumonia, mechanical damage of airways and the lung, and death. The verification of correct tube placement can be done using radiography, or interventions aimed at confirming the location of the tube tip by aspiration of gastric contents, and by auscultation during injection of air.

Approximately 20-25 % of patients treated in intensive care units are likely to need placement of a feeding tube, while undergoing mechanical ventilation and having an artificial airway. This high risk patient group would benefit from technologies allowing direct visualization of tube placement. It is also expected that direct visualization of tube placement will allow confirmation of tube placement and therefore eliminate the need of radiography (radiation).

Eligibility criteria: Inclusion Criteria:

Healthy volunteers

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Age \>18 years

Patients

* Age \>18 years
* mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications
* Informed Consent as documented by signature of relatives

Exclusion Criteria:

Healthy volunteers and patients

* Unrepaired tracheoesophageal fistula
* history of prior esophageal or gastric surgery
* esophageal obstruction, stricture, varices or diverticulum
* esophageal or gastric perforation, gastric or esophageal bleeding
* recent oropharyngeal surgery
* cervical spine injury or anomaly

Additional exclusion criterion for patients only

• know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) \> 3)

Primary outcomes:
measure: Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.
timeFrame: During Intervention Visit, an average of 24 hours
Secondary outcomes:
measure: In healthy volunteers, time required to reach gastric and postpyloric placement
timeFrame: During Intervention Visit, an average of 24 hours
measure: In healthy volunteers, ease of insertion, handling, and image quality assessed
timeFrame: During Intervention Visit, an average of 24 hours
measure: In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction
timeFrame: During Intervention Visit, an average of 24 hours
measure: In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation.
timeFrame: During Intervention Visit, an average of 24 hours
measure: In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value.
timeFrame: During Intervention Visit, an average of 24 hours
measure: In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction.
timeFrame: During Intervention Visit, an average of 24 hours
measure: In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients.
timeFrame: During Intervention Visit, an average of 24 hours
measure: In patients: Time required to reach gastric and postpyloric placement
timeFrame: During Intervention Visit, an average of 24 hours
measure: In patients: Feasibility of the feeding through Veritract tube.
timeFrame: During Intervention Visit, an average of 24 hours
measure: Bleeding and infection related to tube placement
timeFrame: During Intervention Visit, an average of 24 hours
measure: Erroneous placement in larynx and trachea and associated complications (pneumothorax).
timeFrame: During Intervention Visit, an average of 24 hours
measure: Injuries of the oesophagus, stomach or small intestine related to tube placement.
timeFrame: During Intervention Visit, an average of 24 hours
measure: Reflux of stomach contents during tube placement
timeFrame: During Intervention Visit, an average of 24 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitätsklinik für Intensivmedizin
Study officials:
affiliation: Inselspital Bern, Universitätsklinik für Intensivmedizin
name: Tobias Merz, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: