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Placement of Novel Endoscopic Enteral Feeding Tube (LEGEND)

5. september 2018 opdateret af: Nestlé

Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

12

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Bern, Schweiz, 3010
        • Universitätsklinik für Intensivmedizin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patient in ICU mechanically ventilated and requiring a placement of a postpyloric feeding tube

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Andet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Enhed: 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.
Enhed: Tube placement
Placement of enteral feeding tubes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.
Tidsramme: During Intervention Visit, an average of 24 hours
using a visual analog scale of 1-10, with 1 indicating the best value
During Intervention Visit, an average of 24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
In healthy volunteers, time required to reach gastric and postpyloric placement
Tidsramme: During Intervention Visit, an average of 24 hours
Questionnaire with various positions and the time to reach the position
During Intervention Visit, an average of 24 hours
In healthy volunteers, ease of insertion, handling, and image quality assessed
Tidsramme: During Intervention Visit, an average of 24 hours
Using a visual analog scale of 1-10, with 1 indicating the best value
During Intervention Visit, an average of 24 hours
In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction
Tidsramme: During Intervention Visit, an average of 24 hours
Using a visual analog scale of 1-10, with 1 indicating the best value.
During Intervention Visit, an average of 24 hours
In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation.
Tidsramme: 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
During Intervention Visit, an average of 24 hours
In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value.
Tidsramme: During Intervention Visit, an average of 24 hours
using a visual analog scale of 1-10, with 1 indicating the best value
During Intervention Visit, an average of 24 hours
In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction.
Tidsramme: During Intervention Visit, an average of 24 hours
using a visual analog scale of 1-10, with 1 indicating the best value
During Intervention Visit, an average of 24 hours
In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients.
Tidsramme: During Intervention Visit, an average of 24 hours
using a visual analog scale of 1-10, with 1 indicating the best value
During Intervention Visit, an average of 24 hours
In patients: Time required to reach gastric and postpyloric placement
Tidsramme: During Intervention Visit, an average of 24 hours
Questionnaire
During Intervention Visit, an average of 24 hours
In patients: Feasibility of the feeding through Veritract tube.
Tidsramme: During Intervention Visit, an average of 24 hours
using a visual analog scale of 1-10, with 1 indicating the best value
During Intervention Visit, an average of 24 hours
Bleeding and infection related to tube placement
Tidsramme: During Intervention Visit, an average of 24 hours
AE/SAE Questionnaire Yes/No
During Intervention Visit, an average of 24 hours
Erroneous placement in larynx and trachea and associated complications (pneumothorax).
Tidsramme: During Intervention Visit, an average of 24 hours
Outcome mesured with a questionnaire Yes/No
During Intervention Visit, an average of 24 hours
Injuries of the oesophagus, stomach or small intestine related to tube placement.
Tidsramme: During Intervention Visit, an average of 24 hours
Outcome mesured with a questionnaire Yes/No
During Intervention Visit, an average of 24 hours
Reflux of stomach contents during tube placement
Tidsramme: During Intervention Visit, an average of 24 hours
AE/SAE Questionnaire Yes/No
During Intervention Visit, an average of 24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nestlé

Efterforskere

  • Ledende efterforsker: Tobias Merz, Dr. med., Inselspital Bern, Universitätsklinik für Intensivmedizin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. november 2017

Primær færdiggørelse (Faktiske)

7. juni 2018

Studieafslutning (Faktiske)

30. juli 2018

Datoer for studieregistrering

Først indsendt

22. december 2016

Først indsendt, der opfyldte QC-kriterier

26. april 2018

Først opslået (Faktiske)

11. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 16.22.CLI

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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