Respiratory Failure
Conditions
Keywords
Endotracheal Intubation, Checklist, Positioning
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREWritten Checklist
Use of a written checklist pre and peri-intubation
PROCEDUREHead of Bed Up
Raising the patient's head of bed to 25 degrees
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Airway management events will be included in which: 1. Patient is admitted to the Medical Intensive Care Unit (MICU) 2. Planned procedure is endotracheal intubation 3. Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow 4. Administration of sedation and/or neuromuscular blockade is planned 5. Age ≥ 18 years old
Exclusion criteria
Airway management events will be excluded in which: 1. Operator feels specific patient positioning during intubation is required 2. Urgency of intubation precludes safe performance of study procedures 3. Operator feels an alternative pre-procedure checklist or no checklist is required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions) | Time of Induction through 2 minutes after successful intubation | 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 |
| Lowest Systolic Blood Pressure (Checklist intervention only) | Time of Induction through 2 minutes after successful intubation | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Saturation | Time of Induction through 2 minutes after successful intubation | Change in oxygen saturation from baseline to lowest oxygen saturation |
| Grade of First Glottic View | Time of Induction through 2 minutes after successful intubation | Cormack-Lehane grade of view on first intubation attempt |
| First Pass Success | Time of Induction through 2 minutes after successful intubation | 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 |
| Number of Intubation Attempts | Time of Induction through 2 minutes after successful intubation | Number of attempts required for successful tube placement |
| Time to Intubation | Time of Induction through 2 minutes after successful intubation | Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube |
| Need for Assistance | Time of Induction through 2 minutes after successful intubation | Incidence of need for additional intubating equipment, second operator |
| Incidence of Desaturation | Time of Induction through 2 minutes after successful intubation | Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation |
| Malposition of Endotracheal Tube | Time of Induction through 2 minutes after successful intubation | Incidence of post-intubation tube malposition on Chest X-Ray (CXR) |
| Repositioning Patient | Time of Induction through 2 minutes after successful intubation | Incidence of repositioning patient after procedure initiation |
| In-Hospital Mortality | From enrollment through the earlier of hospital discharge or 365 days | Death before hospital discharge |
| Ventilator-free Days | From enrollment through study day 28 | Days alive and free from mechanical ventilation |
| ICU-Free Days | From enrollment through study day 28 | Days alive and out of the ICU |
| Non-hypoxic complications | Time of Induction through 2 minutes after successful intubation | Incidence of non-oxygenation complications - composite of all other recorded complications |
| Incidence of Hypoxemia | Time of Induction through 2 minutes after successful intubation | Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80% |
Countries
United States
Outcome results
None listed