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

Not Applicable

Withdrawn

• Conditions: Breathing Stop
• Interventions: Device: modified Guedel airway

• Registration Number: NCT03637257
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Status Verified: 2020-11
• Study Start: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-06
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Guedel / nasal cannula	modified Guedel airway	Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula
Nasal cannula / Guedel	modified Guedel airway	Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)	90 seconds	Effect of O2 administration on etCO2 measurement

Trial Locations

Locations (1)

University Children´s Hospital; 🇨🇭 Basel, Basel Stadt, Switzerland