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The Safety and Efficacy of Supraglottic Airway Use in Children

27. juli 2015 opdateret af: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.

Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.

The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

10000

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Rekruttering
        • Ann & Robert H. Lurie Children's Hospital of Chicago
        • Kontakt:
        • Ledende efterforsker:
          • Narasimhan Jagannathan, MD

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

1 dag til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.

Beskrivelse

Inclusion Criteria:

  • Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation

Exclusion Criteria:

  • N/A

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Supraglottic Airway Device
Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines
Enhed: Supraglottic Airway Device
Andre navne:
  • LMA Supreme
  • LMA ProSeal
  • I-Gel
  • LMA Unique
  • LMA Flexible
  • Ambu Aura-i
  • Ambu Aura Once
  • Air-Q

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Supraglottic Airway Device Failure
Tidsramme: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ease of Placement of Supraglottic Airway Device
Tidsramme: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Multiple Attempts to Place Supraglottic Airway Device
Tidsramme: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
change in device, placement method, and provider will be recorded
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway Maneuvers/interventions
Tidsramme: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
the number and type of airway maneuvers performed after device placement and during maintenance will be recorded
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Occurrence of Inadequate Ventilation
Tidsramme: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
cause and solution for inadequate ventilation will be recorded
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Intraoperative Complications
Tidsramme: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded
participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Postoperative Complications
Tidsramme: participants will be followed for the duration of anesthesia and 24 hours postoperatively
Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
participants will be followed for the duration of anesthesia and 24 hours postoperatively

Samarbejdspartnere og efterforskere

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

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Efterforskere

  • Ledende efterforsker: Narasimhan Jagannathan, MD, Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. juni 2014

Primær færdiggørelse (Forventet)

1. oktober 2015

Studieafslutning (Forventet)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

25. juli 2014

Først indsendt, der opfyldte QC-kriterier

25. juli 2014

Først opslået (Skøn)

28. juli 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. juli 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2014-15832

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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