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

Respiratory Failure Clinical Trial

— Check-UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497729
• Other study ID #: 150897
• Status: Completed
• Phase: Phase 4
• First received: July 6, 2015
• Last updated: September 16, 2016
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Written Checklist
Use of a written checklist pre and peri-intubation
• Head of Bed Up
Raising the patient's head of bed to 25 degrees

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Vanderbilt University	Nashville	Tennessee
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Change in Saturation	Change in oxygen saturation from baseline to lowest oxygen saturation	Time of Induction through 2 minutes after successful intubation	No
Secondary	Grade of First Glottic View	Cormack-Lehane grade of view on first intubation attempt	Time of Induction through 2 minutes after successful intubation	No
Secondary	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	No
Secondary	Number of Intubation Attempts	Number of attempts required for successful tube placement	Time of Induction through 2 minutes after successful intubation	Yes
Secondary	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	No
Secondary	Need for Assistance	Incidence of need for additional intubating equipment, second operator	Time of Induction through 2 minutes after successful intubation	No
Secondary	Non-hypoxic complications	Incidence of non-oxygenation complications - composite of all other recorded complications	Time of Induction through 2 minutes after successful intubation	Yes
Secondary	Malposition of Endotracheal Tube	Incidence of post-intubation tube malposition on Chest X-Ray (CXR)	Time of Induction through 2 minutes after successful intubation	Yes
Secondary	Repositioning Patient	Incidence of repositioning patient after procedure initiation	Time of Induction through 2 minutes after successful intubation	No
Secondary	In-Hospital Mortality	Death before hospital discharge	From enrollment through the earlier of hospital discharge or 365 days	No
Secondary	Ventilator-free Days	Days alive and free from mechanical ventilation	From enrollment through study day 28	No
Secondary	ICU-Free Days	Days alive and out of the ICU	From enrollment through study day 28	No