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NCT02051816 · ClinicalTrials.gov registry record · NA
Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT02051816 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 150 participants.
The verdict
NCT02051816, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients. Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this setting. While there are many important components of successful airway management in critical illness, the maintenance of adequate arterial hemoglobin saturation from procedure initiation until endotracheal tube placement is paramount as desaturation is the most common factor associated with peri-intubation cardiac arrest and death. Interventions that either shorten the duration of time required for tube placement or prolong the period before desaturation may be effective in improving outcome. The high rate of complications and the lack of existing evidence regarding the efficacy of current airway management techniques in shortening the time to airway establishment or prolonging the time to desaturation mandates further investigation. The primary hypothesis is that video laryngoscopy will be superior to direct laryngoscopy in successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care Medicine fellows after controlling for the operator's past number of procedures with the equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure) will result in a higher arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death)
Interventions
- DEVICE Direct Laryngoscopy
- DEVICE Video Laryngoscopy
- DEVICE Apneic Oxygenation
- DEVICE No Apneic Oxygenation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02051816
The ClinicalTrials.gov registry entry for NCT02051816 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Direct Laryngoscopy is the first listed.
NCT02051816 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02051816 about?
NCT02051816 is a clinical study titled "Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study". Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients. Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this sett...
What is the current status of trial NCT02051816?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2014-02. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02051816?
The interventions under investigation include: Direct Laryngoscopy (DEVICE), Video Laryngoscopy (DEVICE), Apneic Oxygenation (DEVICE), No Apneic Oxygenation (DEVICE).
Who is sponsoring clinical trial NCT02051816?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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