Intubation of Pediatric Dental Surgery PatientsNCT01886807
The Use of Apneic Oxygenation During Prolonged Intubation in Pediatric Patients: a Randomized Clinical Trial
A study testing TrueView PCD Video Laryngoscope in people with Intubation of Pediatric Dental Surgery Patients, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Patient demographics (age, height and weight) will be collected for 546 consecutive patients presenting for dental restoration under general anesthesia. The baseline saturation will be recorded. The induction of anesthesia will be standardized for all patients. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Intubation of Pediatric Dental Surgery Patients
- What is being tested?
- TrueView PCD Video Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled for dental restoration under general nasotracheal anesthesia
- Patient age 1-17 years
- American Society of Anesthesiology physical status I, II, III.
Who cannot join
- Patients at risk of pulmonary aspiration
- Patient with known or suspected difficult airway
- Respiratory infections/disease
- Congenital heart disease
- Hemodynamic instability
- Patients with known latex allergy
Show all 9Show fewer
- Increased intracranial pressure
- Patients with known or suspected basilar skull fracture
- American Society of Anesthesiology physical status ≥ IV
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center Dallas
Dallas, Texas, 75235
About this study
Patient demographics (age, height and weight) will be collected for 546 consecutive patients presenting for dental restoration under general anesthesia. The baseline saturation will be recorded. The induction of anesthesia will be standardized for all patients. All patients will undergo an inhalational induction administered by face mask. After inserting an intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl could be added at the discretion of the anesthesiologist. The patients will be mask ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes after the administration of rocuronium.
Patients will be randomly assigned to one of three groups for the purpose of airway management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation (DLO2 Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL Group). Computer-generated treatment allocations (using the PLAN procedure in SAS statistical software, using random-sized blocks) will be maintained in sequentially numbered sealed envelopes that will be opened after consent is obtained. The laryngoscopy and intubations will be performed by the study investigators who are faculty anesthesiologists or by the mid-level or resident or fellow working with them.
Read more
The study will be stopped when:
- the patient will be intubated and a CO2 trace is obtained on the capnography or
- if the patient desaturates to 90%
- or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or hypotension)
Randomized groups will be compared for balance on potentially confounding baseline variables using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop. We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcomes. Thus our primary hypothesis will be assessed in a joint hypothesis testing framework described by Mascha and Turan. We a-priori define the non-inferiority delta for the outcome time to 1% drop as 5 seconds (or 1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.
Read the detailed description
Secondary outcomes:
Secondary-1. We will conduct tests for superiority to compare the Truview and DL with oxygen cannula methods on each of the two primary outcomes, and report the treatment effect estimates and adjusted confidence intervals. Notably, the study is not powered to be able to assess equivalence between these two oxygen techniques.
Secondary-2. We will compare the three randomized groups on total desaturation slope (rate) using a random slope linear mixed effects model with repeated measures. This model will allow accounting for the variability of the saturation rate for the patients and possible correlation of the saturation measurements within a patient (autoregressive correlation). We only will use saturation data before it reaches 90%.
Secondary-3. We will assess the relative efficacy of Truview and DL with oxygen cannula in preventing 90% saturation compared with DL alone using 2-tailed chi-square tests of proportions (for superiority), summarized with a relative risk and confidence interval.
Secondary -4: We will assess the correlation between the rate of desaturation and both age and body mass index, independent of randomized group. This will be done in the context of a random slope model as in the primary aim, assessing the interaction between the mean desaturation slope and each of age and body mass index.
To restrict overall Type I error of the secondary hypotheses at 5% we will apply Bonferroni correction for multiple inferences and adjustment for interim analyses.
Interim analyses will be conducted every 25% of the maximum planned enrollment using a groups sequential design to test for efficacy and futility. We will use a gamma spending function (gamma = -4 for efficacy and -2 for futility) to maintain the significance level for the primary outcome at 2.5% and the power at 90% across the interim analyses. Significance criteria for all tests will be adjusted for interim analyses based on the above-mentioned gamma spending function and the corresponding z-statistic at teach interim look.
- Being tested
- TrueView PCD Video Laryngoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrueView PCD Video LaryngoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| (DL group) | Other | direct laryngoscopy for nasotracheal intubation without oxygen insufflation Receives: Device: TrueView PCD Video Laryngoscope |
| (DL-O2 Group) | Other | direct laryngoscopy for nasotracheal intubation with oxygen insufflation Receives: Device: TrueView PCD Video Laryngoscope |
| (VL Group) | Experimental | nasotracheal intubation using the Truview PCD video laryngoscope Receives: Device: TrueView PCD Video Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Oxygen Saturation Change
In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome. From start of intubation attempt to completion of intubation.
Measured: From start of intubation attempt to completion of intubation, up to 1 hour
Time to 1% Saturation Drop
Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )
Measured: From beginning to end of laryngoscopy
Secondary outcomes (2)
Heart Rate
Measured: From start of intubation, up to 10 mins
Systolic Blood Pressure
Measured: From start of intubation attempt to completion of intubation, up to 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation of Pediatric Dental Surgery PatientsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Szmuk, University of Texas Southwestern Medical Center
- Investigators
- Jeffrey Steiner, DO, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886807
- Sponsor's protocol ID
- Apneic Oxygenation
- Status last verified
- Mar 2019
- First submitted
- 19 Jun 2013
- Last updated
- 11 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Steiner JW, Sessler DI, Makarova N, Mascha EJ, Olomu PN, Zhong JW, Setiawan CT, Handy AE, Kravitz BN, Szmuk P. Use of deep laryngeal oxygen insufflation during laryngoscopy in children: a randomized clinical trial. Br J Anaesth. 2016 Sep;117(3):350-7. doi: 10.1093/bja/aew186. Epub 2016 Jul 27.
PubMed 27466252
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Apneic Oxygenation During Prolonged Intubation in Pediatric Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01886807
- Acronym / sponsor ID
- Apneic Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 7 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patient demographics (age, height and weight) will be collected for 546 consecutive patients presenting for dental restoration under general anesthesia. The baseline saturation will be recorded. The induction of anesthesia will be standardized for all patients. All patients will undergo an inhalational induction administered by face mask. After inserting an intravenous (IV) line, rocuronium will be administered. Intravenous propofol and fentanyl could be added at the discretion of the anesthesiologist. The patients will be mask ventilated then be with a mixture of Air/Oxygen (O2) to achieve an FiO2 of 0.3 for 3 minutes after the administration of rocuronium.
Patients will be randomly assigned to one of three groups for the purpose of airway management: 1) direct laryngoscopy for nasotracheal intubation without oxygen insufflation (DL group); 2) direct laryngoscopy for nasotracheal intubation with oxygen insufflation (DLO2 Group); and 3) nasotracheal intubation using the Truview PCD video laryngoscope (VL Group). Computer-generated treatment allocations (using the PLAN procedure in SAS statistical software, using random-sized blocks) will be maintained in sequentially numbered sealed envelopes that will be opened after consent is obtained. The laryngoscopy and intubations will be performed by the study investigators who are faculty anesthesiologists or by the mid-level or resident or fellow working with them.
The study will be stopped when:
- the patient will be intubated and a CO2 trace is obtained on the capnography or
- if the patient desaturates to 90%
- or if the patient shows signs of cardiac instability (ectopic beats, arrhythmia or hypotension)
Randomized groups will be compared for balance on potentially confounding baseline variables using descriptive statistics. Primary outcome: In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop. We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcomes. Thus our primary hypothesis will be assessed in a joint hypothesis testing framework described by Mascha and Turan. We a-priori define the non-inferiority delta for the outcome time to 1% drop as 5 seconds (or 1.05 if using hazard ratio) and the slope delta as 0.05 percent per second.
Detailed description
Secondary outcomes:
Secondary-1. We will conduct tests for superiority to compare the Truview and DL with oxygen cannula methods on each of the two primary outcomes, and report the treatment effect estimates and adjusted confidence intervals. Notably, the study is not powered to be able to assess equivalence between these two oxygen techniques.
Secondary-2. We will compare the three randomized groups on total desaturation slope (rate) using a random slope linear mixed effects model with repeated measures. This model will allow accounting for the variability of the saturation rate for the patients and possible correlation of the saturation measurements within a patient (autoregressive correlation). We only will use saturation data before it reaches 90%.
Secondary-3. We will assess the relative efficacy of Truview and DL with oxygen cannula in preventing 90% saturation compared with DL alone using 2-tailed chi-square tests of proportions (for superiority), summarized with a relative risk and confidence interval.
Secondary -4: We will assess the correlation between the rate of desaturation and both age and body mass index, independent of randomized group. This will be done in the context of a random slope model as in the primary aim, assessing the interaction between the mean desaturation slope and each of age and body mass index.
To restrict overall Type I error of the secondary hypotheses at 5% we will apply Bonferroni correction for multiple inferences and adjustment for interim analyses.
Interim analyses will be conducted every 25% of the maximum planned enrollment using a groups sequential design to test for efficacy and futility. We will use a gamma spending function (gamma = -4 for efficacy and -2 for futility) to maintain the significance level for the primary outcome at 2.5% and the power at 90% across the interim analyses. Significance criteria for all tests will be adjusted for interim analyses based on the above-mentioned gamma spending function and the corresponding z-statistic at teach interim look.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| (DL group) | Other | Device: TrueView PCD Video Laryngoscopedirect laryngoscopy for nasotracheal intubation without oxygen insufflation |
| (DL-O2 Group) | Other | Device: TrueView PCD Video Laryngoscopedirect laryngoscopy for nasotracheal intubation with oxygen insufflation |
| (VL Group) | Experimental | Device: TrueView PCD Video Laryngoscopenasotracheal intubation using the Truview PCD video laryngoscope |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children scheduled for dental restoration under general nasotracheal anesthesia
- Patient age 1-17 years
- American Society of Anesthesiology physical status I, II, III.
Key exclusion criteria (9 listed)
- Patients at risk of pulmonary aspiration
- Patient with known or suspected difficult airway
- Respiratory infections/disease
- Congenital heart disease
- Hemodynamic instability
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 |
|---|---|---|
| TrueView PCD Video Laryngoscope | Device | (DL group), (DL-O2 Group), (VL Group) |
Primary outcome
Time of Oxygen Saturation Change
Time frame: From start of intubation attempt to completion of intubation, up to 1 hour
In the primary hypothesis, desaturation will be characterized using both time to 1% saturation drop from the baseline and the rate (slope) of desaturation after an initial 1% drop.We will consider a given intubation technique (DLO2 or VL) better than DL on controlling saturation if found noninferior (i.e., not worse) on both outcomes and superior on at least one of the outcome. From start of intubation attempt to completion of intubation.
Time to 1% Saturation Drop
Time frame: From beginning to end of laryngoscopy
Kaplan-Meyer estimate 25th percentile along with adjusted 95% confidence limits were reported instead of usual 50th percentile (median) since there was not enough non-censored data for the DLO2 group (not many patients dropped 1% in SO2 from their baseline )
2 secondary outcomes
Heart Rate
Time frame: From start of intubation, up to 10 mins
Systolic Blood Pressure
Time frame: From start of intubation attempt to completion of intubation, up to 10 mins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27466252Steiner JW, Sessler DI, Makarova N, Mascha EJ, Olomu PN, Zhong JW, Setiawan CT, Handy AE, Kravitz BN, Szmuk P. Use of deep laryngeal oxygen insufflation during laryngoscopy in children: a randomized clinical trial. Br J Anaesth. 2016 Sep;117(3):350-7. doi: 10.1093/bja/aew186. Epub 2016 Jul 27.
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.
Jeffrey Steiner, DO principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TrueView PCD Video Laryngoscope in people with Intubation of Pediatric Dental Surgery Patients, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 3 inclusion and 9 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 11 Apr 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Oxygen Saturation Change (time frame: From start of intubation attempt to completion of intubation, up to 1 hour). The study lists 2 primary outcomes in all. 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 NCT01886807, 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 11 Apr 2019.