Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study

Vanderbilt University

Status: Completed

Conditions: Respiratory Failure

Treatments: Device: Video Laryngoscopy; Device: Direct Laryngoscopy; Device: No Apneic Oxygenation; Device: Apneic Oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT02051816

131966

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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150 participants in 4 patient groups

VL and AO

Active Comparator group

Description:

Video laryngoscopy and apneic oxygenation

Treatment:

Device: No Apneic Oxygenation

Device: Apneic Oxygenation

DL and AO

Active Comparator group

Description:

Direct Laryngoscopy and apneic oxygenation

Treatment:

Device: No Apneic Oxygenation

Device: Apneic Oxygenation

VL and no AO

Active Comparator group

Description:

Video Laryngoscopy and no apneic oxygenation

Treatment:

Device: Direct Laryngoscopy

Device: Video Laryngoscopy

DL and no AO

Active Comparator group

Description:

Direct Laryngoscopy and no apneic oxygenation

Treatment:

Device: Direct Laryngoscopy

Device: Video Laryngoscopy