Videolaryngoscopy in the Critically Ill (VICI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00911755
First received: May 29, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Endotracheal Intubation
Procedure: Endotracheal Intubation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Evaluate the Efficacy of Video-laryngoscopy vs. Direct Laryngoscopy for Endotracheal Intubation in the Critically Ill Patients: A Pilot Study

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • risk of failure on the first attempt of endotracheal intubation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of attempts at laryngoscopy [ Designated as safety issue: No ]
  • time to successful intubation [ Designated as safety issue: No ]
  • number of complications [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Laryngoscopy Procedure: Endotracheal Intubation
This study is comparing 2 currently accepted methods of endotracheal intubation: laryngoscopy and videolaryngoscopy
Videolaryngoscopy Procedure: Endotracheal Intubation

Detailed Description:

Hypothesis: In this study, we hypothesize that videolaryngoscopy (VL) is associated with a decreased risk of intubation failure compared to direct laryngoscopy in the critically ill. We also hypothesize that VL is associated with fewer number of intubation attempts and decreased risk of complications compared to DL.

Background: In the critically ill, endotracheal intubation is a high-risk procedure with complications occurring in up to 54% of patients. Our own published work has demonstrated that more than one attempt at intubation occurred in 33% of patients and was associated with a three-fold increased risk of severe complications. VL provides a superior laryngeal view when compared to DL which may translate into less failed intubations, and resultant decreased complications.

Specific objectives:

  1. Determine point estimates for failure to intubate on the first attempt, which can then be used to power a larger efficacy trial examining VL vs. DL in the critically ill.
  2. Compare VL vs. DL on risk of intubation failure (as defined by one than more attempt)
  3. Compare VL vs. DL on number of attempts at endotracheal intubation, time-to-intubate, and risk of complications.

Methods:

  1. Design: Single center, randomized-controlled pilot study
  2. Patients: Forty critically ill patients requiring urgent endotracheal intubation (within 30 minutes) by the intensive care team.
  3. Intervention: Patients will be randomized to initial attempt at intubation by VL vs DL.
  4. Power Calculation: Given this is a pilot study to generate point estimates, power calculations have not been performed. However, 20 patients in each arm will provide a robust point estimate that can be used to power a future efficacy study.
  5. Analysis: Data will be analyzed in an intention-to-treat fashion. Our primary objective, failure to intubate on the first attempt, will be analyzed using Fisher's exact test. This test will also be used to analyze the risk of complications comparing VL to DL. Number of attempts at intubation and time-to-intubation will be analyzed using a Wilcoxon rank-sum test.
  6. Potential Pitfalls: As slow recruitment is always a concern, we conservatively estimate that 5 patients will be enrolled per month, thus requiring a total of 8 months for patient accrual.

Significance: If VL results in fewer complications during endotracheal intubation, then this technique may become widely adopted for this high risk procedure. Furthermore, in many centers, anesthesiology support for airway management of the critically ill may be limited, if at all present. Thus, the impact of this research may be even more applicable outside of the tertiary teaching centers where airway management expertise is readily available.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911755

Locations
Canada, British Columbia
Vancouver General Hospital, Intensive Care Unit
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Donald EG Griesdale, MD University of British Columbia
Study Director: 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
  More Information

No publications provided by University of British Columbia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00911755     History of Changes
Other Study ID Numbers: H08-02826
Study First Received: May 29, 2009
Last Updated: February 18, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Laryngoscopy
Glidescope

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014