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NCT01886807 · ClinicalTrials.gov registry record · NA
The Use of Apneic Oxygenation During Prolonged Intubation in Pediatric Patients: a Randomized Clinical Trial
A NA study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 482
- Enrollment target
NCT01886807 is a NA study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 482 participants.
The verdict
NCT01886807, a NA study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 482 participants
- Enrollment target
Study 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. 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% d
Interventions
- DEVICE TrueView PCD Video Laryngoscope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 482 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01886807
The ClinicalTrials.gov registry entry for NCT01886807 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 482 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TrueView PCD Video Laryngoscope is the first listed.
NCT01886807 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01886807 about?
NCT01886807 is a clinical study titled "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 inhalatio...
What is the current status of trial NCT01886807?
This trial is currently completed. It is a NA study. The enrollment target is 482 participants. The study started on 2013-06. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01886807?
The interventions under investigation include: TrueView PCD Video Laryngoscope (DEVICE).
Who is sponsoring clinical trial NCT01886807?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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