NCT01683526

Brief Summary

The safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 25, 2014

Completed
Last Updated

October 20, 2014

Status Verified

October 1, 2014

Enrollment Period

8 months

First QC Date

September 6, 2012

Results QC Date

May 23, 2014

Last Update Submit

October 9, 2014

Conditions

Respiratory Failure

Keywords

Urgent endotrachel intubationDirect laryngoscopyVideo laryngoscopyGlidescopeCritical Care

Outcome Measures

Primary Outcomes (1)

  • First Pass Success Rate

    From begining of intubation to verification. Less then 5 minutes approximatly

Secondary Outcomes (4)

  • Severe Desaturation

    For 10 minutes post intubation

  • Hypotension

    For 10 minutes post intubation

  • Cardiac Arrest

    For 1 hour post intubation

  • Complications of Intubation

    For 10 minutes post intubation

Study Arms (2)

Direct laryngoscopy

ACTIVE COMPARATOR

Intubation will be done using direct laryngoscopy

Procedure: Direct laryngoscopy

Video laryngoscopy

ACTIVE COMPARATOR

Intubation will be done using video laryngoscopy

Device: Video laryngoscopy (Glidescope)

Interventions

Direct laryngoscopyPROCEDURE
Also known as: standard laryngoscope
Direct laryngoscopy
Video laryngoscopy (Glidescope)DEVICE
Also known as: Glidescope Video Laryngoscope
Video laryngoscopy

Eligibility Criteria

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

You may qualify if:

  • All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician

You may not qualify if:

  • Difficult airway
  • Oxygen saturation \< 92% despite adequate mask ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Isreal Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Results Point of Contact

Title
Michael Silverberg
Organization
Beth Israel Medical center
msilverberg2@chpnet.org
2124202377

Study Officials

  • Michael Silverberg, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

September 6, 2012

First Posted

September 12, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 20, 2014

Results First Posted

June 25, 2014

Record last verified: 2014-10

Locations

US(1)