Airway Deadspace in Children: Air-Q Versus Endotracheal Tube

March 25, 2020 updated by: Wake Forest University Health Sciences

A Prospective Comparison of the Airway Deadspace Associated With the Air-Q® and Endotracheal Tube Using Volumetric Capnography in Young Children

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

62

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

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27517
        • Wake Forest Baptist Medical Center

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

Ages Eligible for Study

3 months to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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

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
Air-Q 5-9kg
Participants weighing 5-9kg may be chosen to wear the Air-Q device.
Air-Q 10-14kg
Participants weighing 10-14kg may be chosen to wear the Air-Q device.
Air-Q 15-20kg
Participants weighing 15-20kg may be chosen to wear the Air-Q device.
ETT 5-9kg
Participants weighing 5-9kg may be chosen to wear the ETT device.
ETT 10-14kg
Participants weighing 10-14kg may be chosen to wear the ETT device.
ETT 15-20kg
Participants weighing 15-20kg may be chosen to wear the ETT device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Value of Airway Dead Space
Time Frame: 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.
10 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

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 (Actual)

March 25, 2019

Primary Completion (Actual)

August 9, 2019

Study Completion (Actual)

August 9, 2019

Study Registration Dates

First Submitted

December 19, 2018

First Submitted That Met QC Criteria

December 21, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB00055260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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