Airway MorbidityNCT02627755
GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways.
A study testing aScope® and Glidescope® in people with Airway Morbidity and Anesthesia Intubation Complication, run by Hospital de Manises at 1 site in Spain.
Trial summary
The use in a combined way of two systems of intubation (Glidescope + aScope) would condition an increase in the success rate of endotracheal intubation maneuver compared to conventional isolated Glidescope use in patients with clinical criteria of difficult airway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Morbidity, Anesthesia Intubation Complication
- What is being tested?
- aScope® and Glidescope®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 21 Nov 2016to 21 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients programed for general anesthesia with endotracheal intubation required that presents one or both criteria of difficult airway predictors:
- criteria 1: Arne test >10 (Arne J,1998)
- criteria 2: Ratio between neck circumference and thyromental distance > 4. (Kim WH, 2011)
Who cannot join
- Patients with mouth opening which does not allow the introduction of video laryngoscope.
- Patients with indication of flexible fiberoptic intubation with awake patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways. Assessment of a New Procedure for Endotracheal Intubation in Patients With Suspected Difficult Airways
The use in a combined way of two systems of intubation (Glidescope + aScope) would condition an increase in the success rate of endotracheal intubation maneuver compared to conventional isolated Glidescope use in patients with clinical criteria of difficult airway.
Read the detailed description
Worldwide, up to 600 patients are estimated to die annually as a result of the complications that occur during tracheal intubation The GlideScope® (videolaryngoscope) is used for endotracheal intubation in patients with difficult airway predictors, in this patients overall success intubation rate is 96%. but success intubation rate at first attempt is only 86%.
Despite this positive rates, due to high comorbidity when intubation fails, both failure rates (inverse of success rate) are impermissible. 14% failure at the first attempt intubation as well as 4% overall intubation failure.
in this study the investigators try to show that new procedure associating aScope® (disposable fiberscope) together with GlideScope® increases the success intubation rate of both ( overall and first attempt).
- Being tested
- aScope®, Glidescope®
- Keywords
- videolaryngoscopy, difficult airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aScope®Device
we use the aScope® as a flexible and dirigible guide to facilitate the passage of the endotracheal tube through the vocal cords.
Glidescope®Device
use of Glidescope® in conventional manner to facilitate endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Glide group | Active comparator | Device: Glidescope® use Receives: Device: Glidescope® |
| Glide+aScope group | Experimental | Device: combined use of two airway devices Glidescope® + aScope® Receives: Device: aScope®; Device: Glidescope® |
What is being measured
The primary outcome is the main question the study is designed to answer.
first attempt intubation success rate
first attempt intubation success rate
Measured: through study completion, an average of 1 year.
Secondary outcomes (3)
overall intubation success rate
through study completion, an average of 1 year.
Measured: through study completion, an average of 1 year.
intubation time (in seconds)
during anesthetic induction time until inflate pneumo tamponade after tracheal intubation
Measured: through study completion, an average of 1 year
complications related to intubation
questionnaire
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study start21 Nov 2016
- Primary completionOct 2017 (estimated)
- Study completion21 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Airway MorbidityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Manises
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Responsible party
- Sponsor
- Investigators
- Lucas Rovira Soriano, PhD MD, Study chair, Hospital de ManisesGuido Mazzinari, PhD MD, Principal investigator, Hospital de Manises
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627755
- Sponsor's protocol ID
- ROV-GLI-2015-02
- Status last verified
- Feb 2017
- First submitted
- 30 Nov 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1.
PubMed 22042705Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PubMed 21150569Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050-61. doi: 10.1111/j.1399-6576.2010.02285.x. Epub 2010 Jul 28.
PubMed 20887406Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.
PubMed 21354999Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.
PubMed 9602574Guay J, Williams SR, Robin F, Ruel M. Effect of Intravenous Dexamethasone on the Regression of Isobaric Bupivacaine Spinal Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):e100-e103. doi: 10.1213/ANE.0000000000003670.
PubMed 31094803Mazzinari G, Rovira L, Henao L, Ortega J, Casasempere A, Fernandez Y, Acosta M, Belaouchi M, Esparza-Minana JM. Effect of Dynamic Versus Stylet-Guided Intubation on First-Attempt Success in Difficult Airways Undergoing Glidescope Laryngoscopy: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):1264-1271. doi: 10.1213/ANE.0000000000004102.
PubMed 31094798
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideScope® vs GlideScope® + aScope® for Managing Difficult Airways. Assessment of a New Procedure for Endotracheal Intubation in Patients With Suspected Difficult Airways
- ClinicalTrials.gov ID
- NCT02627755
- Acronym / sponsor ID
- ROV-GLI-2015-02
- Keywords
- videolaryngoscopy, difficult airway management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital de ManisesUniversity, hospital or other
- Collaborators
- Instituto de Investigacion Sanitaria La Fe
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- 21 Nov 2017 (estimated)
- First posted
- 11 Dec 2015 (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.
The use in a combined way of two systems of intubation (Glidescope + aScope) would condition an increase in the success rate of endotracheal intubation maneuver compared to conventional isolated Glidescope use in patients with clinical criteria of difficult airway.
Detailed description
Worldwide, up to 600 patients are estimated to die annually as a result of the complications that occur during tracheal intubation The GlideScope® (videolaryngoscope) is used for endotracheal intubation in patients with difficult airway predictors, in this patients overall success intubation rate is 96%. but success intubation rate at first attempt is only 86%.
Despite this positive rates, due to high comorbidity when intubation fails, both failure rates (inverse of success rate) are impermissible. 14% failure at the first attempt intubation as well as 4% overall intubation failure.
in this study the investigators try to show that new procedure associating aScope® (disposable fiberscope) together with GlideScope® increases the success intubation rate of both ( overall and first attempt).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glide group | Active comparator | Device: Glidescope®Device: Glidescope® use |
| Glide+aScope group | Experimental | Device: aScope®, Device: Glidescope®Device: combined use of two airway devices Glidescope® + aScope® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients programed for general anesthesia with endotracheal intubation required that presents one or both criteria of difficult airway predictors:
- criteria 1: Arne test >10 (Arne J,1998)
- criteria 2: Ratio between neck circumference and thyromental distance > 4. (Kim WH, 2011)
Key exclusion criteria (2 listed)
- Patients with mouth opening which does not allow the introduction of video laryngoscope.
- Patients with indication of flexible fiberoptic intubation with awake patient.
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 |
|---|---|---|
| aScope®we use the aScope® as a flexible and dirigible guide to facilitate the passage of the endotracheal tube through the vocal cords. | Device | Glide+aScope group |
| Glidescope®use of Glidescope® in conventional manner to facilitate endotracheal intubation | Device | Glide group, Glide+aScope group |
Primary outcome
first attempt intubation success rate
Time frame: through study completion, an average of 1 year.
first attempt intubation success rate
3 secondary outcomes
overall intubation success rate
Time frame: through study completion, an average of 1 year.
intubation time (in seconds)
Time frame: through study completion, an average of 1 year
complications related to intubation
Time frame: 30 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 22042705Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1.
- Background: PubMed 21150569Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
- Background: PubMed 20887406Niforopoulou P, Pantazopoulos I, Demestiha T, Koudouna E, Xanthos T. Video-laryngoscopes in the adult airway management: a topical review of the literature. Acta Anaesthesiol Scand. 2010 Oct;54(9):1050-61. doi: 10.1111/j.1399-6576.2010.02285.x. Epub 2010 Jul 28.
- Background: PubMed 21354999Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.
- Background: PubMed 9602574Arne J, Descoins P, Fusciardi J, Ingrand P, Ferrier B, Boudigues D, Aries J. Preoperative assessment for difficult intubation in general and ENT surgery: predictive value of a clinical multivariate risk index. Br J Anaesth. 1998 Feb;80(2):140-6. doi: 10.1093/bja/80.2.140.
- Derived from this study: PubMed 31094803Guay J, Williams SR, Robin F, Ruel M. Effect of Intravenous Dexamethasone on the Regression of Isobaric Bupivacaine Spinal Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):e100-e103. doi: 10.1213/ANE.0000000000003670.
- Derived from this study: PubMed 31094798Mazzinari G, Rovira L, Henao L, Ortega J, Casasempere A, Fernandez Y, Acosta M, Belaouchi M, Esparza-Minana JM. Effect of Dynamic Versus Stylet-Guided Intubation on First-Attempt Success in Difficult Airways Undergoing Glidescope Laryngoscopy: A Randomized Controlled Trial. Anesth Analg. 2019 Jun;128(6):1264-1271. doi: 10.1213/ANE.0000000000004102.
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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.
Lucas Rovira Soriano, PhD MD study chair
Hospital de Manises
Guido Mazzinari, PhD MD principal investigator
Hospital de Manises
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aScope® and Glidescope® in people with Airway Morbidity and Anesthesia Intubation Complication, run by Hospital de Manises at 1 site in Spain.
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 3 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 23 Feb 2017. 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 Spain. 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?
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?
first attempt intubation success rate (time frame: through study completion, an average of 1 year.). 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 NCT02627755, which also lists 7 linked publications.
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 23 Feb 2017.