Clinical trial NCT03785977: Airway Deadspace in Children: Air-Q Versus Endotracheal Tube
Official title: A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Deadspace
Keywords: Ventilation
pediatrics
airway management
respiration
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 62
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To perform this investigation we will use volumetric capnography to examine the airway dead space associated with these devices during and elective general surgery and urologic procedures in healthy children between the ages of 0 and 5 years of age (roughly 5-20 kg).

Brief summary: The objective of this study will be to measure the airway deadspace associated with use of appropriately sized an AirQ, a commonly used supraglottic airway in young children weighing between 5 and 20 kg and compare that to the airway deadspace associated with use of an endotracheal tube (ETT) in similarly sized children undergoing controlled ventilation.

Detailed description: There is an increasing interest in the use of supraglottic airway devices in progressively younger and younger patients. One issue that has not been well evaluated is the contribution of these devices to airway dead space in young children and infants. Volumetric capnography is the only non-invasive technology available at the current time to evaluate airway deadspace. Volumetric capnography essentially monitors the flow of CO2 over time and from the expired waveform one can determine different respiratory parameters including dead space. This is clinically important in young children as the clinician begins to evaluate whether or not to use an endotracheal tube or supraglottic airway in these patients. To perform this investigation the study team will use volumetric capnography to examine the airway dead space associated with these devices during and elective general surgery and urologic procedures in healthy children between the ages of 0 and 6 years of age (roughly 5-20 kg).

Participants in the study will be given ETT or Air-Q as an intervention, but the investigator does not assign specific interventions to the study participants.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 3 months and 6 years of age weighing between 5 and 20 kg
* Patient presenting outpatient urologic or general surgery

Exclusion Criteria:

* History of difficult airway/intubation
* Patients suspected to have a difficult airway.
* Morbid obesity BMI \>39
* Emergency status of surgery
* Patients exposed to second hand smoke
* Patients with Asthma
* Patients with a URI symptom such as nasal drainage, cough, or fever within 7 days of the date of surgery
* History of Prematurity

Primary outcomes:
measure: Mean Value of Airway Dead Space
timeFrame: 10 minutes
Secondary outcomes:
measure: Lung Compliance measured by Respironics NM3 respiratory monitors
timeFrame: 10 minutes
measure: Airway Resistance measured by Respironics NM3 respiratory monitors
timeFrame: 10 minutes
measure: Volume of Carbon Dioxide Associated with the Devices
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas Templeton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Templeton TW, Goenaga-Diaz EJ, Templeton LB, Ririe DG. An in vitro analysis of the dead space in 5 supraglottic airway devices intended for use in small children and infants. Paediatr Anaesth. 2018 Jun;28(6):570-572. doi: 10.1111/pan.13382. No abstract available.
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