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

University Hospital Basel

Status

Withdrawn

Conditions

Breathing Stop

Treatments

Device: modified Guedel airway

Study type

Interventional

Funder types

Other

Identifiers

NCT03637257

UKBB_Anae_CO2_Gued_Feas

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

4 to 24 months old

Volunteers

Accepts Healthy Volunteers

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.