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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497729
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Todd Rice, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Procedure: Written Checklist Procedure: Head of Bed Up Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial
Study Start Date : July 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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 Name: 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 Name: Checklist

Procedure: Head of Bed Up
Raising the patient's head of bed to 25 degrees
Other Names:
  • Patient Positioning
  • Sniff Position




Primary Outcome Measures :
  1. Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions) [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    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

  2. Lowest Systolic Blood Pressure (Checklist intervention only) [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    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 :
  1. Incidence of Desaturation [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation

  2. Incidence of Hypoxemia [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%

  3. Change in Saturation [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Change in oxygen saturation from baseline to lowest oxygen saturation

  4. Grade of First Glottic View [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Cormack-Lehane grade of view on first intubation attempt

  5. First Pass Success [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    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

  6. Number of Intubation Attempts [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Number of attempts required for successful tube placement

  7. Time to Intubation [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube

  8. Need for Assistance [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Incidence of need for additional intubating equipment, second operator

  9. Non-hypoxic complications [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Incidence of non-oxygenation complications - composite of all other recorded complications

  10. Malposition of Endotracheal Tube [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Incidence of post-intubation tube malposition on Chest X-Ray (CXR)

  11. Repositioning Patient [ Time Frame: Time of Induction through 2 minutes after successful intubation ]
    Incidence of repositioning patient after procedure initiation

  12. In-Hospital Mortality [ Time Frame: From enrollment through the earlier of hospital discharge or 365 days ]
    Death before hospital discharge

  13. Ventilator-free Days [ Time Frame: From enrollment through study day 28 ]
    Days alive and free from mechanical ventilation

  14. ICU-Free Days [ Time Frame: From enrollment through study day 28 ]
    Days alive and out of the ICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497729


Locations
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United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Louisiana
Louisiana State University School of Medicine
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center
New Orleans, Louisiana, United States, 70115
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Vanderbilt University
Investigators
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Study Director: Todd W Rice, MD, MSc Vanderbilt University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Todd Rice, Associate Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02497729    
Other Study ID Numbers: 150897
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016
Keywords provided by Todd Rice, Vanderbilt University:
Endotracheal Intubation
Checklist
Positioning
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases