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

NCT02497729 | Completed Phase 4

• 1 other identifier: 150897
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 5

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.

Conditions

Respiratory Failure

Keywords

Endotracheal Intubation; Checklist; Positioning

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Incidence of Desaturation

  Time of Induction through 2 minutes after successful intubation

• Incidence of Hypoxemia

  Time of Induction through 2 minutes after successful intubation

• Change in Saturation

  Time of Induction through 2 minutes after successful intubation

• Grade of First Glottic View

  Time of Induction through 2 minutes after successful intubation

• First Pass Success

  Time of Induction through 2 minutes after successful intubation

Study Arms (4)

Sniffing Position, No Checklist

NO INTERVENTION

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

Sniffing Position, Checklist

ACTIVE COMPARATOR

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

Procedure: Written Checklist

Head of Bed Up, No Checklist

ACTIVE COMPARATOR

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

Procedure: Head of Bed Up

Head of Bed Up, Checklist

ACTIVE COMPARATOR

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

Procedure: Written Checklist; Procedure: Head of Bed Up

Interventions

Written Checklist PROCEDURE

Use of a written checklist pre and peri-intubation

Also known as: Checklist

Head of Bed Up, Checklist; Sniffing Position, Checklist

Head of Bed Up PROCEDURE

Raising the patient's head of bed to 25 degrees

Also known as: Patient Positioning, Sniff Position

Head of Bed Up, Checklist; Head of Bed Up, No Checklist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (5)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70115, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• 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.

  PMID: 28917549 DERIVED

• 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.

  PMID: 28487139 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Checklist; Patient Positioning

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Todd W Rice, MD, MSc

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: July 14, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

US (5)