Airway Leak Pressure Clinical Trial
Official title:
Prospective Evaluation of Pediatric Supraglottic Airways in Anesthetized Children
The supraglottic airway device LMA Supreme has recently been introduced for pediatric
patients. The investigators will prospectively evaluate success rate and airway leak
pressure in everyday's clinical pediatric anesthesia practice. Primary hypothesis is that
the LMA Supreme has a leak pressure with a 95% confidence interval of 18-22cmH2O. Leak
pressures will be compared to results from other pediatric supraglottic airway devices
previously studied by the investigators group. Secondary Hypothesis: The primary success
rate of the LMA-S is higher than 90%; therefore, performance is similar to the performance
of the Ambu Aura Once™ and of the i-gel™. Study design: Prospective controlled observational
cohort study.
In a second step, we will include more pediatric supraglottic airway devices. Each new arm
will be handled exactly the same, assuming the same hypothesis being justified.
The induction of anesthesia will follow the standard operating procedures of the pediatric
anesthesia division at the children's hospital for the use of supraglottic airway devices.
After loss of eyelash reflex and proper bag-mask ventilation provided, the SGA will be
introduced into the mouth under standardized anesthesia to guarantee the same depth of
anesthesia. This includes either propofol 2.5 mg/kg for older children, or sevoflurane
inhalation in younger children at an end-tidal sevoflurane concentration of 6%. The time
necessary to insert the airway device and the success rate will be recorded. We will also
check at what airway pressure the SGA starts leaking. A fiberscope will be inserted through
the airway port and through the gastric tube to obtain a view of the vocal cords and
evaluate the position of the SGA. The gastric catheter will then be placed after insertion;
the size will be according manufacturers' recommendations. After surgery, the SGA will be
checked for evidence of mucosa lesions (blood stains on device). One day after surgery, the
patient (and/or the parents) will be interviewed about sore throat, hoarseness, dysphagia,
postoperative nausea and vomiting (PONV), rescue medication, pain, time of hospital
discharge and any unscheduled re-hospitalization.
Before and during the operation, the following data will be recorded: Sex, age, weight,
surgical procedure and duration, medications needed, cardiovascular parameter, depth of
anesthesia. Secondary outcome data include:
- The insertion time necessary to airway device placement.
- Success rate of SGA device to ventilate patient
- Fiberscope view through the airway port on the glottis opening (1 full vision on the
vocal cords - 4 no structure distinguishable)
- Fiberscope view through the airway gastric tube channel on the upper esophageal
sphincter (rating 1-4)
- Placement of the gastric catheter (yes, no)
- Postoperative: Device will be checked for evidence of mucosa lesions (blood stains on
device).
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Observational Model: Cohort, Time Perspective: Prospective