Acute Respiratory Failure
Conditions
Keywords
Intubation, Bougie
Brief summary
Complications are common during tracheal intubations performed outside of the operating room. Successful intubation on the first attempt has been associated with a lower rate of procedural complications, but the proportion of critically ill patients intubated on the first attempt during tracheal intubations outside of the operating room is less than 90%. The bougie, a thin semi-rigid tube that can be placed into the trachea, allowing a Seldinger-like technique of intubating a patient's airway, has been traditionally reserved for difficult or failed airways. However, a recent single center trial of adult patients intubated in an emergency department demonstrated that use of the bougie on the first attempt improved intubation success, compared to use of a traditional stylet. Theinvestigators propose a multi-center randomized trial to compare first-attempt bougie use versus endotracheal tube with stylet use for tracheal intubation of critically ill adults in the ED and ICU.
Detailed description
The BOUGIE trial is a prospective, parallel group, pragmatic, randomized trial comparing the effect of bougie use versus endotracheal tube with stylet use on the incidence of successful intubation on the first attempt among adults undergoing urgent or emergent tracheal intubation. Patients admitted to the study units who are deemed by their clinical team to require intubation and fulfill inclusion criteria without meeting exclusion criteria will be randomized 1:1 to use of a bougie or use of an endotracheal tube and stylet on the first attempt at intubation. All other decisions regarding airway management, including the choice to use a bougie or endotracheal tube and stylet on subsequent attempts, will remain at the discretion of the treating provider. The trial will enroll 1,106 patients. Conduct of the trial will be overseen by a Data Safety Monitoring Board. An interim analysis will be performed after the enrollment of 553 patients. The analysis of the trial will be conducted in accordance with a pre-specified statistical analysis plan, which will be submitted for publication or made publicly available prior to the conclusion of enrollment. The primary outcome is successful intubation on the first attempt The secondary outcome is severe hypoxemia (lowest arterial oxygen saturation between induction and two minutes following intubation of less than 80%)
Interventions
OTHERBougie
disposable tracheal tube introducer of approximately 70 cm in length
endotracheal tube preloaded with a removable, malleable stylet
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is located in a participating unit of an adult hospital 2. Planned procedure is tracheal intubation with sedative administration (or tracheal intubation without sedative administration during cardiac arrest) 3. Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit 4. Planned laryngoscopy device is a non-hyperangulated laryngoscope blade
Exclusion criteria
1. Patient is pregnant 2. Patient is a prisoner 3. Urgency of intubation precludes safe performance of study procedures 4. Operator feels an approach to intubation other than use of a bougie or use of an endotracheal tube with stylet would be best for the care of the patient 5. Operator feels use of a bougie is required or contraindicated for the care of the patient 6. Operator feels use of an endotracheal tube with stylet is required or contraindicated for the care of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubations with successful intubation on the first attempt | from induction to 2 minutes following tracheal intubation | The primary outcome is successful intubation on the first attempt. Successful intubation on the first attempt is defined as placement of an endotracheal tube in the trachea (confirmed by standard means including capnography) following: (1) a single insertion of a laryngoscope blade into the mouth and (2) EITHER a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth OR a single insertion of an endotracheal tube with stylet into the mouth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of intubations with severe hypoxemia | from induction to 2 minutes following tracheal intubation | Defined as an oxygen saturation less than 80% during the time interval from induction to two minutes after completion of the intubation procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts at passing bougie | from induction to 2 minutes following tracheal intubation | — |
| Number of attempts at passing endotracheal tube | from induction to 2 minutes following tracheal intubation | — |
| Duration of intubation | from the first of induction or initiation of laryngoscopy to 2 minutes following tracheal intubation | The start of the procedure will be defined as either the time of first sedative administration or the time of initiation of laryngoscopy among patients who do not receive a sedative. The end of the procedure will be defined as the time of the final placement of an endotracheal tube within the trachea. |
| Use of video laryngoscope screen | from induction to 2 minutes following tracheal intubation | Operator report of use of video laryngoscope screen on first attempt among intubations where the operator used a video laryngoscope |
| Number of intubations with esophageal intubation | from induction to 2 minutes following tracheal intubation | Operator report of whether or not an esophageal intubation occurred |
| Number of intubations with operator-reported aspiration | from induction to 2 minutes following tracheal intubation | Operator report of whether or not an an aspiration event occurred |
| Cormack-Lehane grade of glottic view on first attempt | from induction to 2 minutes following tracheal intubation | Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen (none of glottis) Grade 4: Neither glottis nor epiglottis seen |
| Number of intubations with cardiac arrest within 1 hour following intubation | within 1 hour following intubation | — |
| Number of intubations with peri-intubation cardiovascular collapse | within 1 hour following intubation | Defined as any of: 1. New systolic blood pressure \< 65 mmHg between induction and 2 minutes following intubation 2. New or increased vasopressor between induction and 2 minutes following intubation 3. Cardiac arrest within 1 hour following intubation 4. Death within 1 hour following intubation |
| The number of ICU-free days, for each intubation, in the first 28 days | 28 days | — |
| The number of ventilator free days, for each intubation, in the first 28 days | 28 days | — |
| The number of patients who experience all-cause in-hospital mortality | 28 days | — |
| Number of intubations with airway trauma | from induction to 2 minutes following tracheal intubation | Operator report of whether or not airway trauma occurred |
| Number of laryngoscopy attempts | from induction to 2 minutes following tracheal intubation | — |
Countries
United States
Outcome results
None listed