Clinical trial NCT02497729: Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
Official title: Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Failure
Keywords: Endotracheal Intubation
Checklist
Positioning
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Lowest Systolic Blood Pressure (Checklist intervention only)
timeFrame: Time of Induction through 2 minutes after successful intubation
Secondary outcomes:
measure: Incidence of Desaturation
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Incidence of Hypoxemia
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Change in Saturation
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Grade of First Glottic View
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: First Pass Success
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Number of Intubation Attempts
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Time to Intubation
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Need for Assistance
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Non-hypoxic complications
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Malposition of Endotracheal Tube
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: Repositioning Patient
timeFrame: Time of Induction through 2 minutes after successful intubation
measure: In-Hospital Mortality
timeFrame: From enrollment through the earlier of hospital discharge or 365 days
measure: Ventilator-free Days
timeFrame: From enrollment through study day 28
measure: ICU-Free Days
timeFrame: From enrollment through study day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: New Orleans
country: United States
facility: Louisiana State University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Todd W Rice, MD, MSc
role: STUDY_DIRECTOR
References:
citation: Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14.
citation: Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6.