- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02471521
Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children
Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children: Study Using Detection of Gastric Insufflation Using Ultrasonography of the Antrum and Epigastric Auscultation
The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients.
The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.
For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients.
The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. Stratum was constructed based on age and randomization scheme was performed separately within each stratum. Block randomization was done to ensure balance of the age groups.
For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.
For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.
Tidal volume and oxygen saturation are recorded during study period.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Seoul, Korea, Republikken, 110-744
- Seoul National University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Pediatric patients scheduled for elective surgery under general anesthesia
- BMI < 30
- ASA class 1 or 2
Exclusion Criteria:
- with difficult airway
- preexisting pulmonary disease
- upper respiratory tract infection
- intestinal obstruction
- with risk of pulmonary aspiration
- history of stoke or moyamoya disease
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Neuromuscular blocker
During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed with after rocuronium administration in children while continuous gastric auscultation and abdominal sonography are performed.
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Mask ventilation is performed after administration of rocuronium or not.
Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods.
Tracheal intubation is done after detection of gas.
Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.
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Aktiv komparator: Non-neuromuscular blocker
During induction of anesthesia, mask ventilation by pressure controlled ventilation is performed without rocuronium in children while continuous gastric auscultation and abdominal sonography are performed.
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Mask ventilation is performed after administration of rocuronium or not.
Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods.
Tracheal intubation is done after detection of gas.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Inspiratory Pressure That Cause Gastric Insufflation
Tidsramme: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
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Difference in the inspiratory pressure that minimized the incidence of gastric insufflation, yet guaranteed a tidal volume of at least 6 ml/kg between the neuromuscular blocker and non-neuromuscular blocker groups. Gastric insufflation was measured using both gastric ultrasonography and epigastric auscultation. |
Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Diagnostic Method That Detects Gastric Insufflation First
Tidsramme: Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
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Interval between start of mask ventilation and detection of gastric insufflation, an expected average of 100 sec
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jin-Tae Kim, MD. PhD., Seoul National University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H-1412-083-633
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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