Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway

Study Overview
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Brief Summary
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This trial compares capnographic signals using a modified CO2/O2 Guedel airway with a CO2/O2 nasal cannula without and with oxygen supply in sedated children aged 4 - 24 months.

Detailed Description
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Sedation of pediatric patients is frequently jeopardized by respiratory adverse events such as central and/or obstructive apnea resulting in hypoxemia. Various factors such as patient comorbidities, medication and inconsistent physiologic monitoring are known to contribute to or facilitate adverse events during sedation. Therefore, monitoring of breathing by capnography is recommended and has become common standard e.g. by the use of a CO2/O2 nasal cannula. However, capnography derived from CO2/O2 nasal cannulas may be impaired and these impairments are exaggerated in infants based on their physiologic characteristics (small tidal volumes, high respiratory rates). To overcome these impairments, the investigators developed a modified CO2/O2 Guedel airway including a CO2 sampling port at the tip of the airway. In a previous study, significantly more accurate capnographic signals resulted compared with measurements derived from a nasal cannula when using a modified CO2/O2 Guedel airway in a model of a breathing 6-month-old manikin. The aim of the study is to examine the accuracy of capnographic measurements of the modified CO2/O2 Guedel airway in comparison with measurements from a CO2/O2 nasal cannula in sedated children aged 4 - 24 months.

Official Title
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Measurement of Expired Carbon Dioxide: Comparison of a Modified CO2/O2 Guedel Airway With a Nasal Cannula in Sedated Children Aged 4-24 Months

Conditions
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Breathing Stop

Intervention / Treatment
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* Device: modified Guedel airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term born infants aged 4 to 24 months Physical status according classification I or II (American Society of Anaesthesiologists (ASA)) Scheduled for elective diagnostic/therapeutic procedures or surgery under sedation/anaesthesia Informed Consent as documented by signature of the parents or legal caregiver Exclusion Criteria: syndrome that affects the airway anatomy Physical status according classification III or IV (American Society of Anaesthesiologists (ASA)) Upper respiratory tract infection at present or within the last two weeks before the study Previous enrolment into the current study Known hypersensitivity or allergic reactions to midazolam, nitrous oxide (N2O), Propofol or Sevoflurane. Positive Family History for malignant hyperthermia, Morbus Pompe or ophthalmic operations with gas injection or Sinus- or inner ear surgery.

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, randomized, single-blinded cross-over study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal cannula / Guedel<br>Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway | Device: modified Guedel airway<br>* Monitoring of breathing<br>|
| Experimental: Guedel / nasal cannula<br>Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula | Device: modified Guedel airway<br>* Monitoring of breathing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end-tidal carbon-dioxide concentration (etCO2) | Difference between capillary and maximum etCO2 sampled via a modified CO2/O2 Guedel airway versus a CO2/O2 nasal cannula | 90 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2) | Effect of O2 administration on etCO2 measurement | 90 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capnography, Pediatric, nasal cannula, Guedel airway