NCT02961933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

3.1 years

First QC Date

November 1, 2016

Last Update Submit

February 10, 2020

Conditions

Intubation

Keywords

hypoxemiaintubationapneic oxygenation

Outcome Measures

Primary Outcomes (1)

  • First pass success without hypoxemia

    10 minutes

Secondary Outcomes (4)

  • Change in peri-intubation saturation

    0, 30, 60 and 120 seconds

  • Saturation at time of tube placement

    10 minutes

  • Time to desaturation <93%

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

  • Saturation at post intubation

    0, 30, 60, and 120 seconds

Study Arms (2)

Apneic oxygenation

EXPERIMENTAL
Other: Apneic oxygenation

non-apneic oxygenation

ACTIVE COMPARATOR
Other: Pre-oxgenation with NRB, NIPPV, BVM

Interventions

Apneic oxygenationOTHER

Nasal cannula apneic oxygenation

Apneic oxygenation
Pre-oxgenation with NRB, NIPPV, BVMOTHER

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

non-apneic oxygenation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Bryant, MD

    Intermountain Health Care, Inc.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Aston, MBA, RT

CONTACT

801-507-4606valerie.aston@imail.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2016

First Posted

November 11, 2016

Study Start

December 1, 2016

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)