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

Breathing Stop Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03637257
• Other study ID #: UKBB_Anae_CO2_Gued_Feas
• Status: Withdrawn
• Phase: N/A
• Start date: November 2020
• Est. completion date: January 2021

Study information

• Verified date: November 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Breathing Stop

Intervention

Device:
• modified Guedel airway
Monitoring of breathing

Locations

Country	Name	City	State
Switzerland	University Children´s Hospital	Basel	Basel Stadt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)	Effect of O2 administration on etCO2 measurement	90 seconds