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

NCT ID: NCT02497729

Last Updated: 2016-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sniffing Position, No Checklist

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Sniffing Position, Checklist

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

Group Type ACTIVE_COMPARATOR

Written Checklist

Intervention Type PROCEDURE

Use of a written checklist pre and peri-intubation

Head of Bed Up, No Checklist

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

Group Type ACTIVE_COMPARATOR

Head of Bed Up

Intervention Type PROCEDURE

Raising the patient's head of bed to 25 degrees

Head of Bed Up, Checklist

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

Group Type ACTIVE_COMPARATOR

Written Checklist

Intervention Type PROCEDURE

Use of a written checklist pre and peri-intubation

Head of Bed Up

Intervention Type PROCEDURE

Raising the patient's head of bed to 25 degrees

Interventions

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Written Checklist

Use of a written checklist pre and peri-intubation

Intervention Type PROCEDURE

Head of Bed Up

Raising the patient's head of bed to 25 degrees

Intervention Type PROCEDURE

Other Intervention Names

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Checklist Patient Positioning Sniff Position

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Todd Rice

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Todd W Rice, MD, MSc

Role: STUDY_DIRECTOR

Vanderbilt University Medical Center

Locations

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University of Alabama - Birmingham

Birmingham, Alabama, United States

Site Status

Louisiana State University School of Medicine

New Orleans, Louisiana, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28917549 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28487139 (View on PubMed)

Other Identifiers

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150897

Identifier Type: -

Identifier Source: org_study_id

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