NCT01091948

Brief Summary

Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration 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

February 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

December 20, 2016

Completed
Last Updated

December 20, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

March 9, 2010

Results QC Date

June 20, 2016

Last Update Submit

October 26, 2016

Conditions

Oral Intubation

Keywords

elective general surgeryorotracheal intubationPatients would be eligible for inclusion if they were at least 18 years old and scheduled for elective surgery requiring orotracheal intubation.

Outcome Measures

Primary Outcomes (1)

  • Time to Intubation (TTI) as Measured in Seconds

    Time from insertion of either the GlideScope or in the case of fibreoptic intubation, a Williams airway (SunMed, Largo, FL, USA) into the mouth, to the time when end-tidal PCO2 exceeded 2.7 kPa (20 mmHg).

    from start of intubation to successfully intubated up to 100 seconds

Secondary Outcomes (6)

  • Intubation Difficulty Score

    from start of intubation to successfully intubated

  • Successful Intubation on 1st Attempt

    from start of first intubation to end of first intubation attempt

  • Occurrence of Hypoxaemia

    at 1 min prior to intubation, intubation, and 2, 4, 6, 8, and 10 min after

  • Trace Bleeding

    Right after intubation

  • Sore Throat Grade

    On the first postoperative day

  • +1 more secondary outcomes

Study Arms (2)

Fiberoptic Intubation

ACTIVE COMPARATOR

Subjects will be intubated with the Fiberoptic laryngoscope.

Device: Intubation with Fiberoptic laryngoscope

GlideScope® Video Laryngoscope

ACTIVE COMPARATOR

Subjects will be intubated with the GlideScope® Video Laryngoscope.

Device: GlideScope® Video Laryngoscope

Interventions

Intubation with Fiberoptic laryngoscopeDEVICE

Subjects will be intubated with the Fiberoptic laryngoscope.

Also known as: Fiberoptic, laryngoscope
Fiberoptic Intubation
GlideScope® Video LaryngoscopeDEVICE

Patients will be intubated with the GlideScope® Video Laryngoscope.

Also known as: GlideScope®, Video Laryngoscope
GlideScope® Video Laryngoscope

Eligibility Criteria

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

You may qualify if:

  • at least 18 years old
  • scheduled for elective surgery requiring orotracheal intubation.

You may not qualify if:

  • known, difficult airway
  • loose teeth
  • pregnant
  • require a rapid sequence induction,
  • Body Mass Index under 30
  • unable to give consent
  • if special endotracheal tube (ETT) is needed for the case.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

IntubationOptical FibersLaryngoscopes

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative TechniquesOptical DevicesEquipment and SuppliesEndoscopesDiagnostic EquipmentSurgical Equipment

Results Point of Contact

Title
Dr. Basem Abdelmalak
Organization
Cleveland Clinic Foundation
abdelmb@ccf.org
216-444-3746

Study Officials

  • Daniel I Sessler, MD

    The Cleveland Clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 24, 2010

Study Start

February 1, 2008

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

December 20, 2016

Results First Posted

December 20, 2016

Record last verified: 2016-10

Locations

US(1)