Evaluation of Supraglottic Airway Devices in Children and Comparison to Historic Control

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01625858
First received: May 31, 2012
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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.


Condition
Evaluation of Success Rate
Airway Leak Pressure
Side Effects of LMA Supreme in Pediatric Patients Undergoing General Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Pediatric Supraglottic Airways in Anesthetized Children

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Airway leak pressure [ Time Frame: After 8 months ] [ Designated as safety issue: Yes ]
    Measured in cmH2O


Secondary Outcome Measures:
  • Number of LMA-S with primary success [ Time Frame: After 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 250
Study Start Date: May 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Supreme / other pediatric SGA
pediatric patients undergoing general anesthesia being treated with LMA Supreme or another pediatric supraglottic airway device

Detailed Description:

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).
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

patients of both genders, ages 0-18 years, ASA physical status I-III, scheduled at the University Hospital of Bern for elective surgery under general anesthesia in supine position with planned operation time <4 hours and planned airway management including a supraglottic airway.

Criteria

Inclusion Criteria:

  • Patients of both genders, ages 0-18 years, ASA physical status I-III, scheduled at the University Hospital of Bern for elective surgery under general anesthesia in supine position with planned operation time <4 hours and planned airway management including a supraglottic airway, written informed consent.

Exclusion Criteria:

  • Exclusion criteria are high risk of aspiration of gastric content into the lungs, body mass index >35kg/m2, cervical spine disease, known difficult airway, upper respiratory tract symptoms in the previous 10 days, preoperative sore throat, poor dentition with high risk of damage, patients not speaking German or refusing to participate.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01625858

Locations
Switzerland
University Hospital Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Chair: Robert Greif, MD MME University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01625858     History of Changes
Other Study ID Numbers: THLD-4-12
Study First Received: May 31, 2012
Last Updated: September 1, 2014
Health Authority: Switzerland: Institutional Review Board, Inselspital

Keywords provided by University Hospital Inselspital, Berne:
LMA Supreme

ClinicalTrials.gov processed this record on September 30, 2014