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Placement of Novel Endoscopic Enteral Feeding Tube (LEGEND)

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ClinicalTrials.gov Identifier: NCT03520582
Recruitment Status : Terminated (stop trial due to proposals for possible optimizations of the device by the investigators.)
First Posted : May 11, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
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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.

Condition or disease Intervention/treatment
Healthy Volunteers Enteral Feeding Device: Tube placement

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).

Study Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : July 30, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
Volunteers
Cohort of 10 healthy subjects. The tube will be placed and removed by a gastroenterologist experienced in performing endoscopic postpyloric tube placement. Secondly, a second tube will be placed and removed.
 Device: Tube placement
Placement of enteral feeding tubes
Mechanically ventilated ICU
Cohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications.
 Device: Tube placement
Placement of enteral feeding tubes


Outcome Measures
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Primary Outcome Measures :
  1. Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    using a visual analog scale of 1-10, with 1 indicating the best value


Secondary Outcome Measures :
  1. In healthy volunteers, time required to reach gastric and postpyloric placement [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Questionnaire with various positions and the time to reach the position

  2. In healthy volunteers, ease of insertion, handling, and image quality assessed [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Using a visual analog scale of 1-10, with 1 indicating the best value

  3. In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Using a visual analog scale of 1-10, with 1 indicating the best value.

  4. In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value

  5. In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    using a visual analog scale of 1-10, with 1 indicating the best value

  6. In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    using a visual analog scale of 1-10, with 1 indicating the best value

  7. In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    using a visual analog scale of 1-10, with 1 indicating the best value

  8. In patients: Time required to reach gastric and postpyloric placement [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Questionnaire

  9. In patients: Feasibility of the feeding through Veritract tube. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    using a visual analog scale of 1-10, with 1 indicating the best value

  10. Bleeding and infection related to tube placement [ Time Frame: During Intervention Visit, an average of 24 hours ]
    AE/SAE Questionnaire Yes/No

  11. Erroneous placement in larynx and trachea and associated complications (pneumothorax). [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Outcome mesured with a questionnaire Yes/No

  12. Injuries of the oesophagus, stomach or small intestine related to tube placement. [ Time Frame: During Intervention Visit, an average of 24 hours ]
    Outcome mesured with a questionnaire Yes/No

  13. Reflux of stomach contents during tube placement [ Time Frame: During Intervention Visit, an average of 24 hours ]
    AE/SAE Questionnaire Yes/No


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube
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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520582


Locations
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Switzerland
Universitätsklinik für Intensivmedizin
Bern, Switzerland, 3010
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Tobias Merz, Dr. med. Inselspital Bern, Universitätsklinik für Intensivmedizin
More Information
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Layout table for additonal information
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03520582    
Other Study ID Numbers: 16.22.CLI
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018