Completed

NCT Number: NCT01886807

The Use of Apneic Oxygenation During Prolonged Intubation in Pediatric Patients: a Randomized Clinical Trial

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.

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Key information

Conditions

Intubation of Pediatric Dental Surgery Patients

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children scheduled for dental restoration under general nasotracheal anesthesia
Patient age 1-17 years
American Society of Anesthesiology physical status I, II, III.

Exclusion criteria

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
Increased intracranial pressure
Patients with known or suspected basilar skull fracture
American Society of Anesthesiology physical status ≥ IV

Treatment and study plan

TrueView PCD Video Laryngoscope

Device

Primary outcomes

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 )

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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Jun 26, 2013
Registry last updated: Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.