Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial

Vanderbilt University

Status and phase: Completed; Phase 4

Conditions: Respiratory Failure

Treatments: Procedure: Head of Bed Up; Procedure: Written Checklist

Study type: Interventional

Funder types: Other

Identifiers

NCT02497729

150897

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 4 patient groups

Sniffing Position, No Checklist

No Intervention group

Description:

Patient in the sniffing position without the use of a written checklist

Sniffing Position, Checklist

Active Comparator group

Description:

Patient in the sniffing position with the use of a written checklist

Treatment:

Procedure: Written Checklist

Head of Bed Up, No Checklist

Active Comparator group

Description:

Patient with the head of bed up and without the use of a checklist

Treatment:

Procedure: Head of Bed Up

Head of Bed Up, Checklist

Active Comparator group

Description:

Patient with the head of bed up and with the use of a checklist

Treatment:

Procedure: Written Checklist

Procedure: Head of Bed Up