Breathing StopNCT03637257
Carbon Dioxide (CO2) Measurement With a CO2/O2 Guedel Airway
A study testing modified Guedel airway in people with Breathing Stop, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 4 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Breathing Stop
- What is being tested?
- modified Guedel airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2020to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children´s Hospital
Basel, Canton of Basel-City, 4056
About this study
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
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.
Read the 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
- Being tested
- modified Guedel airway
- Keywords
- Capnography, Pediatric, nasal cannula, Guedel airway
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified Guedel airwayDevice
Monitoring of breathing
| Study group | Role | What they receive |
|---|---|---|
| Nasal cannula / Guedel | Experimental | Record of capnography using a standard nasal cannula followed by use of a modified Guedel airway Receives: Device: modified Guedel airway |
| Guedel / nasal cannula | Experimental | Record of capnography using a modified Guedel airway followed by use of a standard nasal cannula Receives: Device: modified Guedel airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 seconds
Secondary outcomes (1)
Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)
Effect of O2 administration on etCO2 measurement
Measured: 90 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startNov 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Why it stopped: due to other priorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breathing StopStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomized, single-blinded cross-over study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital Basel
- Responsible party
- Sponsor
- Investigators
- Thomas Erb, Prof. Dr. MD, Principal investigator, UKBB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637257
- Sponsor's protocol ID
- UKBB_Anae_CO2_Gued_Feas
- Status last verified
- Nov 2020
- First submitted
- 7 Aug 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29757925
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03637257
- Acronym / sponsor ID
- UKBB_Anae_CO2_Gued_Feas
- Conditions
- Breathing Stop
- Keywords
- Capnography, Pediatric, nasal cannula, Guedel airway
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due to other priorities
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Children's Hospital Basel
- Study start
- Nov 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, single-blinded cross-over study
| Arm | Type | Receives |
|---|---|---|
| Nasal cannula / Guedel | Experimental | Device: modified Guedel airwayRecord of capnography using a standard nasal cannula followed by use of a modified Guedel airway |
| Guedel / nasal cannula | Experimental | Device: modified Guedel airwayRecord of capnography using a modified Guedel airway followed by use of a standard nasal cannula |
Who may qualify
- Ages
- 4 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified Guedel airwayMonitoring of breathing | Device | Guedel / nasal cannula, Nasal cannula / Guedel |
Primary outcome
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
1 secondary outcome
Change of end-tidal carbon-dioxide concentration (etCO2) according to different oxygen flows (O2)
Time frame: 90 seconds
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Background: PubMed 29757925Moll 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Erb, Prof. Dr. MD principal investigator
UKBB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified Guedel airway in people with Breathing Stop, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end-tidal carbon-dioxide concentration (etCO2) (time frame: 90 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03637257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.