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The Safety and Efficacy of Supraglottic Airway Use in Children

The Safety and Efficacy of Supraglottic Airway Use in Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02202174
Enrollment
10000
Registered
2014-07-28
Start date
2014-06-30
Completion date
2015-10-31
Last updated
2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supraglottic Airway Use in Children

Keywords

supraglottic airway, children, safety, efficacy

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.

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.

Interventions

DEVICESupraglottic Airway Device

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Supraglottic Airway Device Failureparticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursOccurrence and reason for supraglottic airway device failure (ie inadequate ventilation, laryngospasm, bronchospasm, etc) will be recorded in addition to conversion to tracheal intubation

Secondary

MeasureTime frameDescription
Multiple Attempts to Place Supraglottic Airway Deviceparticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hourschange in device, placement method, and provider will be recorded
Airway Maneuvers/interventionsparticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursthe number and type of airway maneuvers performed after device placement and during maintenance will be recorded
Ease of Placement of Supraglottic Airway Deviceparticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursEase of placement of supraglottic airway device ranging from 1 (easy) to 4 (difficult)
Intraoperative Complicationsparticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hoursTime 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
Postoperative Complicationsparticipants will be followed for the duration of anesthesia and 24 hours postoperativelyComplications noted postoperatively relating to reflex activation of the airway, sore throat, or hoarseness
Occurrence of Inadequate Ventilationparticipants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hourscause and solution for inadequate ventilation will be recorded

Countries

United States

Contacts

Primary ContactNarasimhan Jagannathan, MD
njagannathan@luriechildrens.org3122275170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026