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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Written Checklist
Head of Bed Up
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Failure focused on measuring Endotracheal Intubation, Checklist, Positioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama - Birmingham
  • Louisiana State University School of Medicine
  • Ochsner Medical Center
  • Vanderbilt University
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Sniffing Position, No Checklist

Sniffing Position, Checklist

Head of Bed Up, No Checklist

Head of Bed Up, Checklist

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Incidence of Desaturation
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
Incidence of Hypoxemia
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
Change in Saturation
Change in oxygen saturation from baseline to lowest oxygen saturation
Grade of First Glottic View
Cormack-Lehane grade of view on first intubation attempt
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
Number of Intubation Attempts
Number of attempts required for successful tube placement
Time to Intubation
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
Need for Assistance
Incidence of need for additional intubating equipment, second operator
Non-hypoxic complications
Incidence of non-oxygenation complications - composite of all other recorded complications
Malposition of Endotracheal Tube
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
Repositioning Patient
Incidence of repositioning patient after procedure initiation
In-Hospital Mortality
Death before hospital discharge
Ventilator-free Days
Days alive and free from mechanical ventilation
ICU-Free Days
Days alive and out of the ICU

Full Information

First Posted
July 6, 2015
Last Updated
September 16, 2016
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02497729
Brief Title
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
Acronym
Check-UP
Official Title
Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
Endotracheal Intubation, Checklist, Positioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sniffing Position, No Checklist
Arm Type
No Intervention
Arm Description
Patient in the sniffing position without the use of a written checklist
Arm Title
Sniffing Position, Checklist
Arm Type
Active Comparator
Arm Description
Patient in the sniffing position with the use of a written checklist
Arm Title
Head of Bed Up, No Checklist
Arm Type
Active Comparator
Arm Description
Patient with the head of bed up and without the use of a checklist
Arm Title
Head of Bed Up, Checklist
Arm Type
Active Comparator
Arm Description
Patient with the head of bed up and with the use of a checklist
Intervention Type
Procedure
Intervention Name(s)
Written Checklist
Other Intervention Name(s)
Checklist
Intervention Description
Use of a written checklist pre and peri-intubation
Intervention Type
Procedure
Intervention Name(s)
Head of Bed Up
Other Intervention Name(s)
Patient Positioning, Sniff Position
Intervention Description
Raising the patient's head of bed to 25 degrees
Primary Outcome Measure Information:
Title
Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions)
Description
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 Frame
Time of Induction through 2 minutes after successful intubation
Title
Lowest Systolic Blood Pressure (Checklist intervention only)
Description
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 Frame
Time of Induction through 2 minutes after successful intubation
Secondary Outcome Measure Information:
Title
Incidence of Desaturation
Description
Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Incidence of Hypoxemia
Description
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Change in Saturation
Description
Change in oxygen saturation from baseline to lowest oxygen saturation
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Grade of First Glottic View
Description
Cormack-Lehane grade of view on first intubation attempt
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
First Pass Success
Description
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 Frame
Time of Induction through 2 minutes after successful intubation
Title
Number of Intubation Attempts
Description
Number of attempts required for successful tube placement
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Time to Intubation
Description
Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Need for Assistance
Description
Incidence of need for additional intubating equipment, second operator
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Non-hypoxic complications
Description
Incidence of non-oxygenation complications - composite of all other recorded complications
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Malposition of Endotracheal Tube
Description
Incidence of post-intubation tube malposition on Chest X-Ray (CXR)
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
Repositioning Patient
Description
Incidence of repositioning patient after procedure initiation
Time Frame
Time of Induction through 2 minutes after successful intubation
Title
In-Hospital Mortality
Description
Death before hospital discharge
Time Frame
From enrollment through the earlier of hospital discharge or 365 days
Title
Ventilator-free Days
Description
Days alive and free from mechanical ventilation
Time Frame
From enrollment through study day 28
Title
ICU-Free Days
Description
Days alive and out of the ICU
Time Frame
From enrollment through study day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Airway management events will be included in which: Patient is admitted to the Medical Intensive Care Unit (MICU) Planned procedure is endotracheal intubation Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow Administration of sedation and/or neuromuscular blockade is planned Age ≥ 18 years old Exclusion Criteria: Airway management events will be excluded in which: Operator feels specific patient positioning during intubation is required Urgency of intubation precludes safe performance of study procedures Operator feels an alternative pre-procedure checklist or no checklist is required
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd W Rice, MD, MSc
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28917549
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.
Results Reference
derived
PubMed Identifier
28487139
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.
Results Reference
derived

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

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