Airway Deadspace in Children: Air-Q Versus Endotracheal Tube

Completed

• Conditions: Airway Deadspace

• Registration Number: NCT03785977
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Study Start: 2019-03-25
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Value of Airway Dead Space	10 minutes	A mean value observed over the first 10 minutes following placement of the ETT or the AirQ at the beginning of the case will be recorded.

Secondary Outcome Measures

Name	Time	Method
Lung Compliance measured by Respironics NM3 respiratory monitors	10 minutes	The values of lung compliance will be collected and reported.
Volume of Carbon Dioxide Associated with the Devices	10 minutes	The volume of carbon dioxide associated with the devices will be recorded and reported.
Airway Resistance measured by Respironics NM3 respiratory monitors	10 minutes	The value of resistance to flow in the airways will be collected and reported

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States