Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Placement of Novel Endoscopic Enteral Feeding Tube (LEGEND)

5. september 2018 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

12

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Bern, Sveits, 3010
        • Universitätsklinik für Intensivmedizin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Annen

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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.
Enhet: 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.
Enhet: Tube placement
Placement of enteral feeding tubes

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nestlé

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. november 2017

Primær fullføring (Faktiske)

7. juni 2018

Studiet fullført (Faktiske)

30. juli 2018

Datoer for studieregistrering

Først innsendt

22. desember 2016

Først innsendt som oppfylte QC-kriteriene

26. april 2018

Først lagt ut (Faktiske)

11. mai 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. september 2018

Sist bekreftet

1. september 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 16.22.CLI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Friske Frivillige

Kliniske studier på Tube placement

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Mozambique

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere