N/A
N=150
Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study
Respiratory Failure
Bottom Line
View on ClinicalTrials.gov: NCT02051816 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. — 51; 50; NA; NA participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Video Laryngoscopy (Device); Apneic Oxygenation (Device); Direct Laryngoscopy (Device); No Apneic Oxygenation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. |
51; 50; NA; NA | — |
| PRIMARY 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). |
NA; NA; 92; 90 | — |
| SECONDARY Procedure-related Mortality |
0; 0; 0; 1 | — |
| SECONDARY ICU-mortality |
19; 15; 12; 17 | — |
| SECONDARY Adjusted Lowest Arterial Oxygen Saturation During Procedure |
88; 89; 87; 82 | — |
| SECONDARY Ventilator-free Days |
9; 12; 14; 11 | — |
| SECONDARY Number of Esophageal Intubations Per Group |
0; 1; 1; 3 | — |
| SECONDARY Grade View of the Glottis |
1.24; 1.8; 1.3; 1.75 | — |
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) compared to no apneic oxygenation.
Eligibility Criteria
Inclusion Criteria
- Adults
- Medical ICU Patients
- Require endotracheal intubation
- Endotracheal intubation to be performed by Pulmonary/Critical Care Medicine Fellow
- Sedation and/or neuromuscular blockade is planned for the procedure
Exclusion Criteria
- Operators other than Pulmonary/Critical Care Medicine Fellows
- The operator predetermines that the patient requires specific intubating equipment or oxygenation technique will be required for the safe performance of the procedure
Data sourced from ClinicalTrials.gov (NCT02051816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.