Difficult IntubationNCT01789034
Difficult Intubation With Glidescope Video Laryngoscope
An observational study of Difficult Intubation and Complications, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial summary
A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely. Primary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating… Read more about this study
- Who is it for?
- Ages 16 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation, Complications
- How many people
- 2,600 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2011to Jun 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: Patients undergoing neurosurgical procedures eligible for intubation in a tertiary neurosurgical centre
Who may be able to join
- any patient up to ASA4 eligible for intubation for neurosurgical procedures
- any anesthesiologist in charge for GA
Who cannot join
- children
- patient not suitable for clinical evaluation of predictors for difficult intubation (ie. Parkinson's disease)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Neurologico Besta
Milan, 20136
Paolo Cortellazzi, MD, +39022394 ext. 2420, doclampmd@gmail.com
About this study
Official title: Incidence and Predictors of Difficult Intubation Adopting an Institutional Algorithm Glidescope Based: a Cohort Study
A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely.
Primary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating difficulties.
Read the detailed description
All possible factors involved in difficult intubations were included in this prospective analysis.
Main predictors were considered: time to Cormack Lane using Glidescope intubation, Cormack Lane score, experience of the operator (staff or resident), number of bag mask ventilation, number of intubation attempts.
- Conditions
- Difficult Intubation, Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of difficult intubation using Adnet score modified
Difficult intubation in the current study is measured using Adnet score including the number of laryngoscopies
Measured: 3 years
Secondary outcomes (1)
incidence of difficult intubations in novices vs experts and complication in the overall cohort
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IntubationStudies of the same condition, open and under way.
- 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
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- 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, Istituto Nazionale Neurologico Carlo Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789034
- Sponsor's protocol ID
- Besta-2012-01
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictors of Difficult Intubation Adopting an Institutional Algorithm Glidescope Based: a Cohort Study
- ClinicalTrials.gov ID
- NCT01789034
- Acronym / sponsor ID
- Besta-2012-01
- Conditions
- Difficult Intubation, Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2013 (estimated)
- First posted
- 11 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.
A prospective observational study on predictors available and on variables of difficult intubation adopting Gliscope video laryngoscope routinely.
Primary hypothesis of the current study is that the rate of difficult intubation with Glidescope is low and multiple predictors interact favorably in anticipating difficulties.
Detailed description
All possible factors involved in difficult intubations were included in this prospective analysis.
Main predictors were considered: time to Cormack Lane using Glidescope intubation, Cormack Lane score, experience of the operator (staff or resident), number of bag mask ventilation, number of intubation attempts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing neurosurgical procedures eligible for intubation in a tertiary neurosurgical centre
Key inclusion criteria (2 listed)
- any patient up to ASA4 eligible for intubation for neurosurgical procedures
- any anesthesiologist in charge for GA
Key exclusion criteria (2 listed)
- children
- patient not suitable for clinical evaluation of predictors for difficult intubation (ie. Parkinson's disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of difficult intubation using Adnet score modified
Time frame: 3 years
Difficult intubation in the current study is measured using Adnet score including the number of laryngoscopies
1 secondary outcome
incidence of difficult intubations in novices vs experts and complication in the overall cohort
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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
Istituto Nazionale Neurologico Carlo Besta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Intubation and Complications, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site 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 2 inclusion and 2 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 12 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 1 site 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 (+3902239 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?
incidence of difficult intubation using Adnet score modified (time frame: 3 years). 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 12 Feb 2013.