Clinical trial NCT03637257: Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway
Official title: Measurement of Expired Carbon Dioxide: Comparison of a Modified CO2/O2 Guedel Airway With a Nasal Cannula in Sedated Children Aged 4-24 Months
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breathing Stop
Keywords: Capnography
Pediatric
nasal cannula
Guedel airway
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Children's Hospital Basel
First posted: 2018-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized, single-blinded cross-over study
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: end-tidal carbon-dioxide concentration (etCO2)
timeFrame: 90 seconds
Secondary outcomes:
measure: Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)
timeFrame: 90 seconds
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children´s Hospital
state: Basel Stadt
Study officials:
affiliation: UKBB
name: Thomas Erb, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moll J, Anagnostopoulou P, Frei FJ, Erb TO. A modified CO2/O2 Guedel airway improves capnographic accuracy compared with a CO2/O2 nasal cannula: An infant manikin study. Eur J Anaesthesiol. 2018 Aug;35(8):566-572. doi: 10.1097/EJA.0000000000000818.