Back to results

Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation (USE AP OX)

Primary Purpose

Intubation

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Apneic oxygenation

Pre-oxgenation with NRB, NIPPV, BVM

About this trial

This is an interventional supportive care trial for Intubation focused on measuring hypoxemia, intubation, apneic oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium)

Exclusion Criteria:

Known prisoners
Patients in cardiac arrest
Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).

Sites / Locations

Intermountain Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apneic oxygenation

non-apneic oxygenation

Arm Description

Outcomes

Primary Outcome Measures

First pass success without hypoxemia

Secondary Outcome Measures

Change in peri-intubation saturation

Saturation at time of tube placement

Time to desaturation <93%

Saturation at post intubation

Full Information

NCT ID

NCT02961933

First Posted

November 1, 2016

Last Updated

February 10, 2020

Sponsor

Intermountain Health Care, Inc.

Collaborators

University of Utah

1. Study Identification

Unique Protocol Identification Number

NCT02961933

Brief Title

Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation

Acronym

USE AP OX

Official Title

Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

January 2020 (Actual)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intermountain Health Care, Inc.

Collaborators

University of Utah

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intubation

Keywords

hypoxemia, intubation, apneic oxygenation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apneic oxygenation

Arm Type

Experimental

Arm Title

non-apneic oxygenation

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Apneic oxygenation

Intervention Description

Nasal cannula apneic oxygenation

Intervention Type

Other

Intervention Name(s)

Pre-oxgenation with NRB, NIPPV, BVM

Intervention Description

Pre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask

Primary Outcome Measure Information:

Title

First pass success without hypoxemia

Time Frame

10 minutes

Secondary Outcome Measure Information:

Title

Change in peri-intubation saturation

Time Frame

0, 30, 60 and 120 seconds

Title

Saturation at time of tube placement

Time Frame

10 minutes

Title

Time to desaturation <93%

Time Frame

measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes

Title

Saturation at post intubation

Time Frame

0, 30, 60, and 120 seconds

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium) Exclusion Criteria: Known prisoners Patients in cardiac arrest Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Valerie Aston, MBA, RT

Phone

801-507-4606

valerie.aston@imail.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Bryant, MD

Organizational Affiliation

Intermountain Health Care, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intermountain Medical Center

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valerie Aston, MBA, RT

Phone

801-507-4606

Valerie.Aston@imail.org

First Name & Middle Initial & Last Name & Degree

Rob Bryant, MD

First Name & Middle Initial & Last Name & Degree

Joseph Bledsoe, MD

First Name & Middle Initial & Last Name & Degree

Hill Stoecklein, MD

First Name & Middle Initial & Last Name & Degree

Megan Fix, MD

First Name & Middle Initial & Last Name & Degree

Amber Bledsoe, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation

We'll reach out to this number within 24 hrs