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

Completed · Not applicable

Conditions studied: Intubation of Pediatric Dental Surgery Patients

In brief

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.

Key facts

Study ID

NCT01886807

Run by

University of Texas Southwestern Medical Center

People needed

482

Starts

2013-06-01

Expected to finish

2015-05-01

Last updated by the study team

2019-04-11

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Children's Medical Center Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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