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

September 1, 2014 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Supreme / other pediatric SGA
pediatric patients undergoing general anesthesia being treated with LMA Supreme or another pediatric supraglottic airway device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Airway leak pressure
Time Frame: After 8 months
Measured in cmH2O
After 8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of LMA-S with primary success
Time Frame: After 8 months
After 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Inselspital, Berne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Robert Greif, MD MME, University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THLD-4-12

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