- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00969189
Evaluation of the Pediatric Igel Airway in 250 Children
A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
Once a child has been anaesthetised and is fully asleep, a special airway tube called a laryngeal mask is often inserted into their mouth to help with their breathing. This tube is removed just before the child wakes up.
A new type of airway tube, called an i-gel airway, has been developed for children, which is hoped will be easier to insert, safer once in position, and will be less likely to cause a sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has been available for adults since 2007, and early trials have shown very encouraging results.
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Avon
-
Bristol, Avon, Det Forenede Kongerige, BS2 8BJ
- UH Bristol NHS Foundation Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All children weighing 5 -30kg
- Classified by the American Society of Anesthesiology (ASA) as grade 1-2,
- Scheduled for elective surgery under general anaesthesia, in whom a LMA or PLMA would otherwise be used for airway maintenance and in whom neuromuscular blocking drugs will not be used.
Exclusion Criteria:
- Inability of patient or parents to understand the study or consent process
- Neck pathology
- Previous or anticipated airway problems
- Pathology of airway, respiratory tract, upper gastrointestinal tract
- Increased risk of regurgitation or aspiration
- Weight >30kg or <5 kg
- ASA 3 and above,
- Emergency surgery
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
---|
Children
between 10 and 30 kgs
|
Infants
between 5 - 10 kg
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
Tidsramme: during anaesthesia
|
during anaesthesia
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae
Tidsramme: during anaesthesia and up to 24 hours postoperatively
|
during anaesthesia and up to 24 hours postoperatively
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michelle White, MB ChB, UH Bristol NHS Foundation Trust
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- CH/2008/2808
- NRES ID: 08/H0101/198
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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