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

NCT ID: NCT03637257

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-01-31

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.

Conditions

Breathing Stop

Keywords

Capnography; Pediatric; nasal cannula; Guedel airway

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Nasal cannula / Guedel

Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway

Group Type: EXPERIMENTAL

modified Guedel airway

Intervention Type: DEVICE

Monitoring of breathing

Guedel / nasal cannula

Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula

Group Type: EXPERIMENTAL

modified Guedel airway

Intervention Type: DEVICE

Monitoring of breathing

Interventions

modified Guedel airway

Monitoring of breathing

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 4 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Children's Hospital Basel

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Erb, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

UKBB

Locations

University Children´s Hospital

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 29757925 (View on PubMed)

Other Identifiers

UKBB_Anae_CO2_Gued_Feas

Identifier Type: -

Identifier Source: org_study_id