A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.
The investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.
The two devices have now pediatric sizes.
To date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.
The chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:
- time to achieve an effective airway,
- ease of insertion,
- need for interventions to achieve an effective airway,
- cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,
- ventilatory variables during mechanical ventilation,
- fiberoptic score,
- gastric tube insertion and
- adverse perioperative events.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.
Exclusion Criteria:
- Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Laryngeal Tube Suction Disposable
Laryngeal Tube Suction Disposable for ventilation
|
Device for ventilation
|
|
Eksperimentel: Laryngeal Mask Airway AuraGain
Laryngeal Mask Airway AuraGain for oxygenation and ventilation
|
Ventilation device
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Leak pressure measure in cm H2O
Tidsramme: 60 seconds
|
60 seconds
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to insertion a device in seconds
Tidsramme: 60 seconds
|
60 seconds
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Andre undersøgelses-id-numre
- BnaiZionMC-16-LG-012
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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