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Completed

NCT Number: NCT02497729

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Checklist

Procedure

Use of a written checklist pre and peri-intubation

Other names: Checklist

Head of Bed Up

Procedure

Raising the patient's head of bed to 25 degrees

Other names: Patient Positioning, Sniff Position

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Acronym: Check-UP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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