InfantsNCT01664234
Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
A study testing laryngoscopy with oxygen and laryngoscopy without oxygen in people with Infants and Difficult Airway, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Infants, Difficult Airway
- What is being tested?
- laryngoscopy with oxygen and laryngoscopy without oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2012to 30 Dec 2014
- 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 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants (0-2) difficult airways
Who cannot join
- . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting
Trial locations and contacts
1 site in 1 country.
About this study
Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.
- Conditions
- Infants, Difficult Airway
- Being tested
- laryngoscopy with oxygen, laryngoscopy without oxygen
- Keywords
- infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21
- Medical subject headings
- Pierre Robin Syndrome, Mandibulofacial Dysostosis, Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngoscopy with oxygenOther
Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
laryngoscopy without oxygenOther
Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
| Study group | Role | What they receive |
|---|---|---|
| laryngoscopy with simultaneous insufflation of oxygen | Experimental | Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Receives: Other: laryngoscopy with oxygen |
| laryngoscopy without simultaneous oxygen insufflation | Placebo comparator | Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Receives: Other: laryngoscopy without oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to oxygen saturation
The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.
Measured: Day 1
Secondary outcomes (1)
mean oxygenation comparison
Randomized groups will be compared on mean oxygen saturation at the time of intubation using a 2-sample t-test
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study start1 Jan 2012
- Primary completion30 Dec 2014
- Study completion30 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Plattner, Medical University of Vienna
- Investigators
- Olga Plattner, M.D., Principal investigator, Medizinischen Universität Wien Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664234
- Sponsor's protocol ID
- ECS 1178/2012
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2012
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children
- ClinicalTrials.gov ID
- NCT01664234
- Acronym / sponsor ID
- ECS 1178/2012
- Conditions
- Infants, Difficult Airway
- Keywords
- infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Dec 2014 (actual)
- First posted
- 14 Aug 2012 (estimated)
- 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.
Infants (0-1 yr.) with anticipated difficult airways will be enrolled in the study. Specifically, we will include infants with cleft palate, Pierre Robin, Treacher Collins, trisomy 21, or similar congenital malformations. Patients with American Society of Anesthesiologists physical status scores ≥3 will be excluded, as will those with congenital heart disease and left-to-right shunting. Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. Randomization (1:1) will be based on computer-generated codes with random block sizes and stratified by hospital; allocation will be concealed and provided to clinicians via a secure web site that will be accessed shortly before induction of anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laryngoscopy with simultaneous insufflation of oxygen | Experimental | Other: laryngoscopy with oxygenPatients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. |
| laryngoscopy without simultaneous oxygen insufflation | Placebo comparator | Other: laryngoscopy without oxygenPatients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- infants (0-2) difficult airways
Key exclusion criteria (1 listed)
- . Patients with American Society of Anesthesiologists physical status scores ≥3 congenital heart disease left-to-right shunting
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 |
|---|---|---|
| laryngoscopy with oxygenPatients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq. | Other | laryngoscopy with simultaneous insufflation of oxygen |
| laryngoscopy without oxygenPatients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute. | Other | laryngoscopy without simultaneous oxygen insufflation |
Primary outcome
time to oxygen saturation
Time frame: Day 1
The randomized groups will be compared on time between laryngoscope (airtraq) insertion and reaching an oxygen saturation of 90%using a 2-tailed t-test or Wilcoxon-Mann-Whitney test, as appropriate.
1 secondary outcome
mean oxygenation comparison
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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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.
Olga Plattner, M.D. principal investigator
Medizinischen Universität Wien Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngoscopy with oxygen and laryngoscopy without oxygen in people with Infants and Difficult Airway, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 2023. 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 Austria. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to oxygen saturation (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2023.