Utah Study Evaluating Apneic Oxygenation for Emergency De... | NCT02961933

Studies
Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation

NCT02961933

Sponsor

Intermountain Health Care, Inc.

Status

Unknown status

Last Update Posted

Feb 11, 2020Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Intubation

Interventions

Apneic oxygenation
Pre-oxgenation with NRB, NIPPV, BVM

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Jan 2020Actual

Completion Date

Jun 2020Estimated

First Submitted Date

Nov 1, 2016

First Submission Date that Met QC Criteria

Nov 8, 2016

First Posted Date

Nov 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2020

Last Update Posted Date

Feb 11, 2020Actual

Name	Class
University of Utah	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apneic oxygenation	Experimental		Other: Apneic oxygenation
non-apneic oxygenation	Active Comparator		Other: Pre-oxgenation with NRB, NIPPV, BVM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Apneic oxygenation	Other	Nasal cannula apneic oxygenation	Apneic oxygenation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First pass success without hypoxemia		10 minutes

Secondary Outcomes

Measure	Description	Time Frame
Change in peri-intubation saturation		0, 30, 60 and 120 seconds
Saturation at time of tube placement		10 minutes
Time to desaturation <93%

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valerie Aston, MBA, RT	Contact	801-507-4606		valerie.aston@imail.org

Overall Officials

Name	Affiliation	Role
Robert Bryant, MD	Intermountain Health Care, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intermountain Medical Center	Recruiting	Murray	Utah	84107	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000860	Hypoxia

Ancestor Terms

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided