Anesthesia Intubation ComplicationNCT01790646
Learning and Performance of Glidescope® Videolaryngoscope Intubation
An observational study of Anesthesia Intubation Complication, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 3 sites in Italy.
Trial summary
Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its learning curve was prooved on manikin but not in adult patients. Read more about this study
- Who is it for?
- Ages 16 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- intubation
- How many people
- 600 participants
- Where
- 3 sitesItaly
- Study dates
- Sep 2012to May 2013
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: elective neurosurgical patients from a tertiary neurosurgical centre
Who may be able to join
- any patient undergoing GA
Who cannot join
- patients with predicted difficult intubation undergoing awake intubation
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Istituto Neurologico Besta
Milan, 20136
Paolo Cortellazzi, MD, +39022304 ext. 2420, paolo.cortellazzi@istituto-besta.it
Paolo Cortellazzi, MD, +3902239 ext. 2420, paolo.cortellazzi@istituto-besta.it
- Recruiting
Istituto Neurologico Besta
Milan, 20136
Paolo Lamperti, MD, +39022394 ext. 2420
- Recruiting
Istituto Neurologico Besta
Milan, 20136
Massimo Lamperti, MD, +39022394 ext. 2420, paolo.cortellazzi@istituto-besta.it
Paolo Cortellazzi, MD
About this study
Official title: Learning and Performance of Glidescope® Videolaryngoscope Intubation in Anesthesiologists Trained in Direct Laryngoscopy: a "in Vivo" Study
Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its learning curve was prooved on manikin but not in adult patients.
Read the detailed description
Glidescope® Videolaryngoscope is an angulated rigid optical device introduced in clinical practice in 2004 to facilitate endotracheal intubation.
Since its introduction potential benefits of this instrument might lie with use in patients with clinical features indicating difficult laryngoscopy or it being used as a rescue method following failed direct laryngoscopy. In a few centers was proposed and used routinely.
The performance of Glidescope® was studied in easy and difficult scenarios, in vivo and on manikins and compared with the reference standard McIntosh direct laryngoscopy. In patients with predicted or simulated difficult intubation, despite glottis visualization was improved with Glidescope®, the introduction of the tube in trachea was difficult the same as with McIntosh laryngoscopy. Training of operators before to entertain the trials varied from 20 to 50 Glidescope successful intubations. In an observational study Aziz et al. demonstrated in the two Institutions involved that the GlideScope® was used more frequently at the Institution were the failure rate was significantly lower. At this , 51 providers performed mean 21.7 GlideScope® intubations while at the other 91 providers performed 9.9 intubations.
These data highlight the important issue of how many Glidescope® intubations a provider should complete to reach a definitive clinical competence in this practice. Until now there is only one study performed on mankin comparing Glidescope® with AirTraq® and McIntosh laryngoscopes in novices . The authors concluded that despite a steep learning curve after 5 intubation difficulties in instrumentation and longer times to intubate persisted with Glidescope® in comparison with the other two devices. Outcome measures were: duration of intubation attempt, modified Cormack grades, dental trauma and difficulty of use.
In vivo both timely insertion of laryngoscope blade and introduction of the tube, no need of help or of external laryngeal displacement should be included to ascertain expertise with this new technology in patients with different grades of difficulty predicted.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intubationOther
intubation using Glidescope videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing general anesthesia | every elective patient undergoing general anesthesia for neurosurgical procedures with endotracheal intubation Receives: Other: intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
from Glidescope blade insertion to succefull introduction of the tracheal tube and tube secured in the trachea with ETCO2 confirmation of tracheal ventilation
Measured: from induction of GA to successful intubation
Secondary outcomes (1)
Features useful to define a Glidescope intubation successful
the following criteria have to be satisfied: one introduction of the laryngoscope, one introduction of the tube, Cormack-leane 1, no external laryngeal displacement, time to intubation <43 seconds, no need for help of an external operator, no complications
Measured: successfull intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Lamperti, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Investigators
- Paolo Cortellazzi, MD, Principal investigator, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790646
- Sponsor's protocol ID
- INCCB 2012-02
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning and Performance of Glidescope® Videolaryngoscope Intubation in Anesthesiologists Trained in Direct Laryngoscopy: a "in Vivo" Study
- ClinicalTrials.gov ID
- NCT01790646
- Acronym / sponsor ID
- INCCB 2012-02
- Conditions
- Anesthesia Intubation Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 13 Feb 2013 (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.
Glidescope laryngoscope was introduced as a novel tool for difficult intubation. Its learning curve was prooved on manikin but not in adult patients.
Detailed description
Glidescope® Videolaryngoscope is an angulated rigid optical device introduced in clinical practice in 2004 to facilitate endotracheal intubation.
Since its introduction potential benefits of this instrument might lie with use in patients with clinical features indicating difficult laryngoscopy or it being used as a rescue method following failed direct laryngoscopy. In a few centers was proposed and used routinely.
The performance of Glidescope® was studied in easy and difficult scenarios, in vivo and on manikins and compared with the reference standard McIntosh direct laryngoscopy. In patients with predicted or simulated difficult intubation, despite glottis visualization was improved with Glidescope®, the introduction of the tube in trachea was difficult the same as with McIntosh laryngoscopy. Training of operators before to entertain the trials varied from 20 to 50 Glidescope successful intubations. In an observational study Aziz et al. demonstrated in the two Institutions involved that the GlideScope® was used more frequently at the Institution were the failure rate was significantly lower. At this , 51 providers performed mean 21.7 GlideScope® intubations while at the other 91 providers performed 9.9 intubations.
These data highlight the important issue of how many Glidescope® intubations a provider should complete to reach a definitive clinical competence in this practice. Until now there is only one study performed on mankin comparing Glidescope® with AirTraq® and McIntosh laryngoscopes in novices . The authors concluded that despite a steep learning curve after 5 intubation difficulties in instrumentation and longer times to intubate persisted with Glidescope® in comparison with the other two devices. Outcome measures were: duration of intubation attempt, modified Cormack grades, dental trauma and difficulty of use.
In vivo both timely insertion of laryngoscope blade and introduction of the tube, no need of help or of external laryngeal displacement should be included to ascertain expertise with this new technology in patients with different grades of difficulty predicted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing general anesthesia | – | Other: intubationevery elective patient undergoing general anesthesia for neurosurgical procedures with endotracheal intubation |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- elective neurosurgical patients from a tertiary neurosurgical centre
Key inclusion criteria (1 listed)
- any patient undergoing GA
Key exclusion criteria (1 listed)
- patients with predicted difficult intubation undergoing awake 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 |
|---|---|---|
| intubationintubation using Glidescope videolaryngoscope | Other | patients undergoing general anesthesia |
Primary outcome
number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient
Time frame: from induction of GA to successful intubation
from Glidescope blade insertion to succefull introduction of the tracheal tube and tube secured in the trachea with ETCO2 confirmation of tracheal ventilation
1 secondary outcome
Features useful to define a Glidescope intubation successful
Time frame: successfull intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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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.
Paolo Cortellazzi, MD principal investigator
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Intubation Complication, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 3 sites in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paolo Cortellazzi, MD (+39022394 ext. 2420, paolo.cortellazzi@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of attempts with Glidescope laryngoscopy necessary for beeing considered proficient (time frame: from induction of GA to successful intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2013.