NCT00911755

Brief Summary

Endotracheal Intubation (ETI) is done to place a plastic tube in a patient's trachea (windpipe) to assist with breathing. Patients admitted to the intensive care unit (ICU) are the sickest of patients and the majority of them require this life saving procedure. A critical illness can be sudden and ETI required urgently. The doctors performing ETI in these situations may not be experts at ETI. Studies have shown that if it takes more than one attempt to get the tube in the right position patients can have severe complications such as: decrease level of oxygen in the body, decrease blood pressure, and cardiac arrest. These complications can be life threatening and increase the length of time spent in an ICU. To perform ETI the doctor uses a metal tool called a laryngoscope that is placed through the patient's mouth to open the throat and then pass the tube into the trachea. The type of procedure that has been used for many years is called Direct Laryngoscopy (DL) which means that the doctor looks through the mouth directly into the throat. Newer technology is available and can be used at VGH called Video Laryngoscopy (VL). With VL there is a camera on the end of the laryngoscope and a video image is displayed on a monitor making it easier to see the entrance to the trachea. VL is not available for all cases at VGH and is unavailable in many other hospitals. In this study we will compare DL to VL. Patients will be randomly placed in one of two groups: first attempt at ETI done with DL or first attempt of ETI done with DL. Patients will only be considered eligible for this study if the doctor feels that either DL or VL would be appropriate for the patient. In this pilot study we hope show that conducting a larger study would be feasible. If a larger study were to show that VL decreases complications and shortens length of ICU stay we would be able to recommend this procedure for all ETI at VGH as well as other hospitals where it currently may not be available.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

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

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

3.1 years

First QC Date

May 29, 2009

Last Update Submit

February 18, 2014

Conditions

Keywords

LaryngoscopyGlidescope

Outcome Measures

Primary Outcomes (1)

  • risk of failure on the first attempt of endotracheal intubation

Secondary Outcomes (3)

  • number of attempts at laryngoscopy

  • time to successful intubation

  • number of complications

Study Arms (2)

Laryngoscopy

OTHER
Procedure: Endotracheal Intubation

Videolaryngoscopy

OTHER
Procedure: Endotracheal Intubation

Interventions

This study is comparing 2 currently accepted methods of endotracheal intubation: laryngoscopy and videolaryngoscopy

Laryngoscopy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient over the age of 16 years, requiring urgent (within 30 minutes) endotracheal intubation, who are attended to by the critical care team will be eligible for enrolment

You may not qualify if:

  • Patients who require intubation within 5 minutes or have contraindications to either of the study intubation technique will be ineligible
  • cardiac arrest
  • cardiopulmonary instability (oxygen saturation \<90% or systolic blood pressure \< 80 mmHg despite oxygen or fluid therapy)
  • any clinical deterioration while awaiting randomization
  • known prior or anticipated difficult intubation
  • need for awake intubation (defined by sedation, topicalization and avoidance of neuromuscular blockade)
  • pregnancy
  • cervical spine precautions
  • any patient deemed inappropriate for enrolment by the attending physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital, Intensive Care Unit

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

  • Griesdale DE, Chau A, Isac G, Ayas N, Foster D, Irwin C, Choi P; Canadian Critical Care Trials Group. Video-laryngoscopy versus direct laryngoscopy in critically ill patients: a pilot randomized trial. Can J Anaesth. 2012 Nov;59(11):1032-9. doi: 10.1007/s12630-012-9775-8. Epub 2012 Aug 30.

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Donald EG Griesdale, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR
  • P Choi

    University of British Columbia

    STUDY DIRECTOR
  • G Isac

    University of British Columbia

    STUDY DIRECTOR
  • V Dhingra

    University of British Columbia

    STUDY DIRECTOR
  • A Chau

    University of British Columbia

    STUDY DIRECTOR
  • C Menon

    University of British Columbia

    STUDY DIRECTOR

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

May 29, 2009

First Posted

June 2, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations