- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02380768
A Comparison of the Ambu AuraGain Versus LMA Supreme in Children
17. juli 2015 opdateret af: Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago
A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme.
Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, and peri-operative complications will also be assessed.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Ann & Robert H Lurie Children's Hospital of Chicago
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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
3 måneder til 6 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Scheduled for surgery utilizing a supraglottic airway device
- ASA (American Society of Anesthesiologists) I-III classification
- Weighing between 5 - 20 kilograms
Exclusion Criteria:
- Active respiratory infection
- History of difficult mask ventilation
- Diagnosis of congenital syndrome with difficult airway management
- Active gastrointestinal reflux
- Coagulopathy
- Significant Pulmonary disease
- Emergent surgery
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ambu AuraGain
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
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The device will be inserted and timed.
A leak pressure test will be performed after successful insertion and after 10 minutes.
The larynx will be visualized by placing a fiberoptic bronchoscope through the device.
A gastric tube will be inserted through the device and timed.
Andre navne:
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Aktiv komparator: LMA Supreme
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
|
The device will be inserted and timed.
A leak pressure test will be performed after successful insertion and after 10 minutes.
The larynx will be visualized by placing a fiberoptic bronchoscope through the device.
A gastric tube will be inserted through the device and timed.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Oropharyngeal (airway) leak pressure - Initial
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
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Assessed intraoperatively at the time of confirmed device placement
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Oropharyngeal (airway) leak pressure - 10 Minutes
Tidsramme: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
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The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway
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Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Time for Successful Placement of the Supraglottic Airway
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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Time for successful placement of supraglottic device will be recorded
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Assessed intraoperatively at the time of confirmed device placement
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Number of attempts to placement of Supraglottic Airway
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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Number of attempts and insertion techniques will be recorded (maximum of 3 attempts)
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Assessed intraoperatively at the time of confirmed device placement
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Fiberoptic Grade of Laryngeal View through Supraglottic Airway
Tidsramme: Assessed intraoperatively at the time of confirmed device placement
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Fiberoptic Grade of Laryngeal View through either device will be graded using a previously published grading system
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Assessed intraoperatively at the time of confirmed device placement
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Gastric Tube Insertion Ease of Placement
Tidsramme: Assessed intraoperatively at the time of confirmed gastric tube placement
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The ease of placement, based on a 1-4 scale, will be recorded following placement and confirmation of the gastric tube.
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Assessed intraoperatively at the time of confirmed gastric tube placement
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Gastric Tube Insertion Time
Tidsramme: Assessed intraoperatively at the time of confirmed gastric tube placement
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The elapsed time from beginning insertion of the gastric tube to confirmation, will be recorded.
Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
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Assessed intraoperatively at the time of confirmed gastric tube placement
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Gastric Tube Insertion Attempts
Tidsramme: Assessed intraoperatively at the time of confirmed gastric tube placement
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Number of insertion attempts of the gastric tube through the SGA will be recorded.
Confirmation of gastric tube placement will be determined by injection of air with auscultation (listening for sounds) over the stomach with a stethoscope.
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Assessed intraoperatively at the time of confirmed gastric tube placement
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Postoperative Complications
Tidsramme: Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
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Patient will be evaluated for sore throat, cough, dysphonia, stridor, or other airway related complications during the post-operative period.
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Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.
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Intraoperative Complications
Tidsramme: Assessed intraoperatively
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Complications such as reflex activation of the airway (coughing, breath holding, laryngospasm, bronchospasm), oxygen desaturation will be recorded, if they occur.
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Assessed intraoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Narasimhan Jagannathan, M.D., Ann & Robert H Lurie Children's Hospital of Chicago
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
- White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.
- Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.
- Jagannathan N, Ramsey MA, White MC, Sohn L. An update on newer pediatric supraglottic airways with recommendations for clinical use. Paediatr Anaesth. 2015 Apr;25(4):334-45. doi: 10.1111/pan.12614. Epub 2015 Jan 13.
- Jagannathan N, Sohn L, Sommers K, Belvis D, Shah RD, Sawardekar A, Eidem J, Dagraca J, Mukherji I. A randomized comparison of the laryngeal mask airway supreme and laryngeal mask airway unique in infants and children: does cuff pressure influence leak pressure? Paediatr Anaesth. 2013 Oct;23(10):927-33. doi: 10.1111/pan.12145. Epub 2013 Mar 23.
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. marts 2015
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. juni 2015
Datoer for studieregistrering
Først indsendt
26. februar 2015
Først indsendt, der opfyldte QC-kriterier
2. marts 2015
Først opslået (Skøn)
5. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB 2015-252
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 .
Kliniske forsøg med Supraglottic Airway
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