search
Back to results

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

Primary Purpose

Breathing Stop

Status
Withdrawn
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
modified Guedel airway
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breathing Stop focused on measuring Capnography, Pediatric, nasal cannula, Guedel airway

Eligibility Criteria

4 Months - 24 Months (Child)All SexesAccepts 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.

Sites / Locations

  • University Children´s Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nasal cannula / Guedel

Guedel / nasal cannula

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2018
Last Updated
November 4, 2020
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Children's Hospital Basel
search

1. Study Identification

Unique Protocol Identification Number
NCT03637257
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
due to other priorities
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Children's Hospital Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breathing Stop
Keywords
Capnography, Pediatric, nasal cannula, Guedel airway

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, randomized, single-blinded cross-over study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal cannula / Guedel
Arm Type
Experimental
Arm Description
Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway
Arm Title
Guedel / nasal cannula
Arm Type
Experimental
Arm Description
Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula
Intervention Type
Device
Intervention Name(s)
modified Guedel airway
Intervention Description
Monitoring of breathing
Primary Outcome Measure Information:
Title
end-tidal carbon-dioxide concentration (etCO2)
Description
Difference between capillary and maximum etCO2 sampled via a modified CO2/O2 Guedel airway versus a CO2/O2 nasal cannula
Time Frame
90 seconds
Secondary Outcome Measure Information:
Title
Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)
Description
Effect of O2 administration on etCO2 measurement
Time Frame
90 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Erb, Prof. Dr. MD
Organizational Affiliation
UKBB
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children´s Hospital
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4056
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29757925
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs