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The Safety and Efficacy of Supraglottic Airway Use in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02202174
Recruitment Status : Unknown
Verified July 2015 by Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was:  Recruiting
First Posted : July 28, 2014
Last Update Posted : July 29, 2015
Sponsor:
Information provided by (Responsible Party):
Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary:
This purpose of this study is to determine the effectiveness, risk factors, and complications associated with use of supraglottic airway devices for primary airway maintenance during routine anesthesia in children.

Condition or disease Intervention/treatment
Supraglottic Airway Use in Children Device: Supraglottic Airway Device

Detailed Description:

This study aims to understand the efficacy of supraglottic airway (SGA) use in children in a tertiary care Children's Hospital.

Observational data regarding the type of SGA, experience level of practitioner, placement technique, number of placement attempts or placement failure, device failure, and cause of any related peri-operative complications will be prospectively collected.

The data collected in this study will allow the investigators to assess the overall safety and efficacy of SGA use in various medical and surgical procedures performed under general anesthesia in children.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Safety and Efficacy of Supraglottic Airway Use in Children
Study Start Date : June 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Group/Cohort Intervention/treatment
Supraglottic Airway Device
Patients will receive a supraglottic airway device as a primary means of ventilation. The following devices may be used: LMA Unique, LMA ProSeal, LMA Supreme, LMA Flexible, Ambu Aura-I, Ambu Aura Once, Air-Q, I-Gel, or other supraglottic airway device. Choice of the device will be clinician dependent and based on the patients body weight per manufacturer guidelines
Device: Supraglottic Airway Device
Other Names:
  • LMA Unique
  • LMA ProSeal
  • LMA Supreme
  • LMA Flexible
  • Ambu Aura-i
  • Ambu Aura Once
  • Air-Q
  • I-Gel




Primary Outcome Measures :
  1. Supraglottic Airway Device Failure [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Occurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation


Secondary Outcome Measures :
  1. Ease of Placement of Supraglottic Airway Device [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Ease of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)

  2. Multiple Attempts to Place Supraglottic Airway Device [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    change in device, placement method, and provider will be recorded

  3. Airway Maneuvers/interventions [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    the number and type of airway maneuvers performed after device placement and during maintenance will be recorded

  4. Occurrence of Inadequate Ventilation [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    cause and solution for inadequate ventilation will be recorded

  5. Intraoperative Complications [ Time Frame: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours ]
    Time period of complication (ie during device placement, maintenance, or removal) and cause of complication (ie. dental injury, light anesthesia, regurgitation, laryngospasm, bronchospasm, aspiration, etc.) will be recorded

  6. Postoperative Complications [ Time Frame: participants will be followed for the duration of anesthesia and 24 hours postoperatively ]
    Complications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients undergoing anesthesia with use of a supraglottic airway device as primary means of oxygenation and ventilation.
Criteria

Inclusion Criteria:

  • Children undergoing anesthesia with use of a supraglottic airway device as a primary means of oxygenation & ventilation

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202174


Contacts
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Contact: Narasimhan Jagannathan, MD 3122275170 njagannathan@luriechildrens.org

Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Narasimhan Jagannathan, MD       simjag2000@yahoo.com   
Principal Investigator: Narasimhan Jagannathan, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
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Principal Investigator: Narasimhan Jagannathan, MD Ann & Robert H. Lurie Children's Hospital of Chicago / Stanley Manne Research Institute
Publications:
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Responsible Party: Narasimhan Jagannathan, Primary Investigator; MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02202174    
Other Study ID Numbers: 2014-15832
First Posted: July 28, 2014    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Narasimhan Jagannathan, Ann & Robert H Lurie Children's Hospital of Chicago:
supraglottic airway
children
safety
efficacy