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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: Written Checklist; Procedure: Head of Bed Up

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama - Birmingham
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University School of Medicine
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Sniffing Position, No Checklist; Patient in the sniffing position without the use of a written checklist
Active Comparator: Sniffing Position, Checklist; Patient in the sniffing position with the use of a written checklist	Procedure: Written Checklist; Use of a written checklist pre and peri-intubation; Other Names: Checklist
Active Comparator: Head of Bed Up, No Checklist; Patient with the head of bed up and without the use of a checklist	Procedure: Head of Bed Up; Raising the patient's head of bed to 25 degrees; Other Names: Patient Positioning; Sniff Position
Active Comparator: Head of Bed Up, Checklist; Patient with the head of bed up and with the use of a checklist	Procedure: Written Checklist; Use of a written checklist pre and peri-intubation; Other Names: Checklist; Procedure: Head of Bed Up; Raising the patient's head of bed to 25 degrees; Other Names: Patient Positioning; Sniff Position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 of Induction through 2 minutes after successful intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Desaturation	Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation	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 of Induction through 2 minutes after successful intubation
Change in Saturation	Change in oxygen saturation from baseline to lowest oxygen saturation	Time of Induction through 2 minutes after successful intubation
Grade of First Glottic View	Cormack-Lehane grade of view on first intubation attempt	Time of Induction through 2 minutes after successful intubation
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 of Induction through 2 minutes after successful intubation
Number of Intubation Attempts	Number of attempts required for successful tube placement	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 of Induction through 2 minutes after successful intubation
Need for Assistance	Incidence of need for additional intubating equipment, second operator	Time of Induction through 2 minutes after successful intubation
Non-hypoxic complications	Incidence of non-oxygenation complications - composite of all other recorded complications	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 of Induction through 2 minutes after successful intubation
Repositioning Patient	Incidence of repositioning patient after procedure initiation	Time of Induction through 2 minutes after successful intubation
In-Hospital Mortality	Death before hospital discharge	From enrollment through the earlier of hospital discharge or 365 days
Ventilator-free Days	Days alive and free from mechanical ventilation	From enrollment through study day 28
ICU-Free Days	Days alive and out of the ICU	From enrollment through study day 28

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Study Director: Todd W Rice, MD, MSc, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: September 16, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Checklist; Endotracheal Intubation; Positioning
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 150897