General anesthetized patients requiring endtracheal intubation
Conditions
Interventions
Intervention: Intubate using cuffed tracheal tube (Microcuffe endotracheal tube / Halyard Healthcare, Inc.)
Control: Intubate using uncuffed tracheal tube (PORTEX endotracheal tube / Smiths Medica
Sponsors
Department of intensive care and anesthesia, National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children who are undergoing elective surgery or examination requiring enrtracheal intubation under general anesthesia 2) Children with parental written informed consent 3) Children who are planed to extubabe in operation room, stay at recovery room until getting stable, and then go back to ward 4) Children from newborns to younger than 6 years of age (Newborns are required to be born at full-term of gestation and weight more than or equal to 3 kg.)
Exclusion criteria
Exclusion criteria: 1) Children who are undergoing urgent or emergency surgery 2) Children who have impaired functions of airway and/or swallowing 3) Children who are known or predicted to have difficulty in airway management 4) Children who have upper respiratory infection within 2 weeks or lower respiratory infection within 4 weeks 5) Children who are undergoing surgical interventions into airway itself or lung (e.g. adenoidectomy) 6) Children who had been enrolled in this study 7) Children with severe general status (ASA PS >2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of inspiratory stridor after extubation in operation room and/or recovery room | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Secondary outcomes 1) Tube exchange 2) Therapy for inspiratory stridor after extubation (nebulized epinephrine and/or continuous positive airway pressure) 3) Time from extubation to leaving recovery room 4) Impaired airway track due to intubation itself (laryngospasm and/or tracheal hemorrhage) 5) Re-intubation 6) Unexpected ICU-admission due to airway problems 7) Need for oxygen at the time of leaving recovery room 8) Residual inspiratory stridor at the time of leaving recovery room 2. Experimental endpoints 1) Accidental one lung ventilation 2) Adjustment of tube position after intubation 3) Reliability of EtCO2 wave 4) Need for fresh gas flow more than 4L/min 5) Adjustment of cuff pressure due to accidental change in cuff pressure (Group A) 6) Change in length of tube position more than or equal to 1 cm 7) Need for pharyngeal gauze packing 8) Inappropriate location of tube tip detected with chest X-ray | — |
Countries
Japan
Contacts
Public ContactYasuhiro Kogure
National Center for Child Health and Development Department of intensive care and anesthesia
Outcome results
None listed