Endotracheal IntubationVICINCT00911755
Videolaryngoscopy in the Critically Ill
A study testing Endotracheal Intubation in people with Endotracheal Intubation, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Endotracheal Intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- pregnancy
- cervical spine precautions
- any patient deemed inappropriate for enrolment by the attending physician
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver General Hospital, Intensive Care Unit
Vancouver, British Columbia, V5Z 1M9
About this study
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
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.
Read the 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:
- 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.
- Compare VL vs. DL on risk of intubation failure (as defined by one than more attempt)
- Compare VL vs. DL on number of attempts at endotracheal intubation, time-to-intubate, and risk of complications.
Methods:
- Design: Single center, randomized-controlled pilot study
- Patients: Forty critically ill patients requiring urgent endotracheal intubation (within 30 minutes) by the intensive care team.
- Intervention: Patients will be randomized to initial attempt at intubation by VL vs DL.
- 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.
- 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.
- 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.
- Conditions
- Endotracheal Intubation
- Being tested
- Endotracheal Intubation
- Keywords
- Laryngoscopy, Glidescope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal IntubationProcedure or surgery
This study is comparing 2 currently accepted methods of endotracheal intubation: laryngoscopy and videolaryngoscopy
Endotracheal IntubationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Laryngoscopy | Other | Not described Receives: Procedure: Endotracheal Intubation |
| Videolaryngoscopy | Other | Not described Receives: Procedure: Endotracheal Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endotracheal IntubationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald EG Griesdale, MD, Principal investigator, University of British ColumbiaP Choi, Study director, University of British ColumbiaG Isac, Study director, University of British ColumbiaV Dhingra, Study director, University of British ColumbiaA Chau, Study director, University of British ColumbiaC Menon, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911755
- Sponsor's protocol ID
- H08-02826
- Acronym
- VICI
- Status last verified
- Feb 2014
- First submitted
- 29 May 2009
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22932944
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00911755
- Acronym / sponsor ID
- VICI / H08-02826
- Conditions
- Endotracheal Intubation
- Keywords
- Laryngoscopy, Glidescope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Compare VL vs. DL on risk of intubation failure (as defined by one than more attempt)
- Compare VL vs. DL on number of attempts at endotracheal intubation, time-to-intubate, and risk of complications.
Methods:
- Design: Single center, randomized-controlled pilot study
- Patients: Forty critically ill patients requiring urgent endotracheal intubation (within 30 minutes) by the intensive care team.
- Intervention: Patients will be randomized to initial attempt at intubation by VL vs DL.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laryngoscopy | Other | Procedure: Endotracheal Intubation |
| Videolaryngoscopy | Other | Procedure: Endotracheal Intubation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endotracheal IntubationThis study is comparing 2 currently accepted methods of endotracheal intubation: laryngoscopy and videolaryngoscopy | Procedure or surgery | Laryngoscopy |
| Endotracheal Intubation | Procedure or surgery | Videolaryngoscopy |
Primary outcome
risk of failure on the first attempt of endotracheal intubation
3 secondary outcomes
number of attempts at laryngoscopy
time to successful intubation
number of complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Derived from this study: PubMed 22932944Griesdale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald EG Griesdale, MD principal investigator
University of British Columbia
P Choi study director
University of British Columbia
G Isac study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal Intubation in people with Endotracheal Intubation, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk of failure on the first attempt of endotracheal intubation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911755, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.