The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
260
Use of a written checklist pre and peri-intubation
Raising the patient's head of bed to 25 degrees
University of Alabama - Birmingham
Birmingham, Alabama, United States
Louisiana State University School of Medicine
New Orleans, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Vanderbilt University
Nashville, Tennessee, United States
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure
Time frame: Time of Induction through 2 minutes after successful intubation
Lowest Systolic Blood Pressure (Checklist intervention only)
Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only)
Time frame: Time of Induction through 2 minutes after successful intubation
Incidence of Desaturation
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
Time frame: Time of Induction through 2 minutes after successful intubation
Incidence of Hypoxemia
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
Time frame: Time of Induction through 2 minutes after successful intubation
Change in Saturation
Change in oxygen saturation from baseline to lowest oxygen saturation
Time frame: Time of Induction through 2 minutes after successful intubation
Grade of First Glottic View
Cormack-Lehane grade of view on first intubation attempt
Time frame: Time of Induction through 2 minutes after successful intubation
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University of Washington
Seattle, Washington, United States
First Pass Success
Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices
Time frame: Time of Induction through 2 minutes after successful intubation
Number of Intubation Attempts
Number of attempts required for successful tube placement
Time frame: Time of Induction through 2 minutes after successful intubation
Time to Intubation
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
Time frame: Time of Induction through 2 minutes after successful intubation
Need for Assistance
Incidence of need for additional intubating equipment, second operator
Time frame: Time of Induction through 2 minutes after successful intubation
Non-hypoxic complications
Incidence of non-oxygenation complications - composite of all other recorded complications
Time frame: Time of Induction through 2 minutes after successful intubation
Malposition of Endotracheal Tube
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
Time frame: Time of Induction through 2 minutes after successful intubation
Repositioning Patient
Incidence of repositioning patient after procedure initiation
Time frame: Time of Induction through 2 minutes after successful intubation
In-Hospital Mortality
Death before hospital discharge
Time frame: From enrollment through the earlier of hospital discharge or 365 days
Ventilator-free Days
Days alive and free from mechanical ventilation
Time frame: From enrollment through study day 28
ICU-Free Days
Days alive and out of the ICU
Time frame: From enrollment through study day 28