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

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ClinicalTrials.gov Identifier: NCT03637257
Recruitment Status : Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
University Children's Hospital Basel
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
To compare 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.

Condition or disease Intervention/treatment Phase
Breathing Stop Device: modified Guedel airway Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Prospective, randomized, single-blinded cross-over study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Arm Intervention/treatment
Experimental: Nasal cannula / Guedel
Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway
Device: modified Guedel airway
Monitoring of breathing

Experimental: Guedel / nasal cannula
Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula
Device: modified Guedel airway
Monitoring of breathing




Primary Outcome Measures :
  1. end-tidal carbon-dioxide concentration (etCO2) [ Time Frame: 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 :
  1. Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2) [ Time Frame: 90 seconds ]
    Effect of O2 administration on etCO2 measurement



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Ages Eligible for Study:   4 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637257


Contacts
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Contact: Thomas O Erb, Prof. Dr. MD 0041617042822 thomas.erb@ukbb.ch

Locations
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Switzerland
University Children´s Hospital Not yet recruiting
Basel, Basel Stadt, Switzerland, 4056
Contact: Thomas O Erb, Prof. Dr. MD    0041617042822    thomas.erb@ukbb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Children's Hospital Basel
Investigators
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Principal Investigator: Thomas Erb, Prof. Dr. MD UKBB

Publications:
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03637257     History of Changes
Other Study ID Numbers: UKBB_Anae_CO2_Gued_Feas
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University Hospital, Basel, Switzerland:
Capnography
Pediatric
nasal cannula
Guedel airway
Additional relevant MeSH terms:
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Respiratory Aspiration
Apnea
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms