Intubation;DifficultNCT04174833
GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening
An observational study of Intubation;Difficult and Videolaryngoscopy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study aims to evaluate the clinical performance, quality of larynx visualization and difficulty of videolaryngoscopic intubation in patients with a reduced mouth opening (1.0 to 3.0 cm) utilizing the latest generation of GlideScopeTM Spectrum low profile laryngoscopy system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation;Difficult, Videolaryngoscopy, Small Mouth
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jan 2021to 17 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for non-cardiac surgery under general anesthesia with a need for endotracheal intubation presenting at the Anesthesiology Preassessment Clinic of the Hamburg University Hospital with a mouth opening between 1.0 and 3.0 cm within the recruiting period.
Who may be able to join
- Patients scheduled for non-cardiac surgery
- Required general anesthesia and endotracheal intubation
- Mouth opening between 1.0 and 3.0 cm (any reason) recognized during preoperative assessment
- Written consent provided
Who cannot join
- Pregnant or breastfeeding women
- Confirmed indication for awake fiberoptic intubation, especially due to enoral and pharyngeal tumors, abscesses or other obstructive lesions
- Endotracheal intubation planned without deep general anesthesia or without neuromuscular blockade (e.g. awake videolaryngoscopy)
- Qualification for rapid sequence anesthesia induction due to risk of pulmonary aspiration
- Loose teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening, a Prospective Cohort Study
This study aims to evaluate the clinical performance, quality of larynx visualization and difficulty of videolaryngoscopic intubation in patients with a reduced mouth opening (1.0 to 3.0 cm) utilizing the latest generation of GlideScopeTM Spectrum low profile laryngoscopy system.
Read the detailed description
Reduced mouth opening in adults has been proven an important risk factor for difficult endotracheal intubation utilizing both direct and indirect laryngoscopy techniques, and a major reason for anesthesia-related adverse events. Over the past two decades, videolaryngoscopy has evolved to be the primary indirect laryngoscopy technique in a difficult endotracheal intubation setting. The possibility for optimal visualization of the laryngeal structures renders this method particularly helpful in patients with limited mouth opening. Especially videolaryngoscopy with acute-angle blades has been proposed to be favorable over conventional direct laryngoscopy in this setting. However, previous research has shown that a mouth opening of approximately 2.0 - 3.0 cm represents an independent risk factor and a possible critical lower limit for safe videolaryngoscopic intubation.
The latest generation of GlideScopeTM Spectrum blades may provide sufficient intubation conditions even in patients with a maximum mouth opening below 3.0 cm.
Our research group aims to evaluate the clinical performance, quality of larynx visualization and severity of videolaryngoscopic intubation the GlideScopeTM Spectrum system in patients with a small mouth opening.
- Conditions
- Intubation;Difficult, Videolaryngoscopy, Small Mouth
- Keywords
- GlideScope, Airway Management, Videolaryngoscopic Intubation
- Medical subject headings
- Microstomia
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful videolaryngoscopic endotracheal intubation rate
Observation during airway management
Measured: Within 1 hour after anesthesia induction
Secondary outcomes (5)
First pass success rate
Observation during airway management
Measured: Within 1 hour after anesthesia induction
Endotracheal intubation difficulty
Subjective rating on a numeric rating scale [0-100]; 0 - very easy; 100 - very difficult
Measured: Within 1 hour after concluded endotracheal intubation
Best view obtained
Cormack-Lehane classification
Measured: Within 1 hour after concluded endotracheal intubation
Intubation time
Observation during airway management
Measured: Within 1 hour after anesthesia induction
Number of attempts
Observation during airway management
Measured: Within 1 hour after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start20 Jan 2021
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Verathon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174833
- Sponsor's protocol ID
- PV6094
- Status last verified
- Nov 2021
- First submitted
- 6 Oct 2019
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlideScope Videolaryngoscopy in Patients With Reduced Mouth Opening, a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04174833
- Acronym / sponsor ID
- PV6094
- Conditions
- Intubation;Difficult, Videolaryngoscopy, Small Mouth
- Keywords
- GlideScope, Airway Management, Videolaryngoscopic Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Verathon
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 22 Nov 2019 (actual)
- 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.
This study aims to evaluate the clinical performance, quality of larynx visualization and difficulty of videolaryngoscopic intubation in patients with a reduced mouth opening (1.0 to 3.0 cm) utilizing the latest generation of GlideScopeTM Spectrum low profile laryngoscopy system.
Detailed description
Reduced mouth opening in adults has been proven an important risk factor for difficult endotracheal intubation utilizing both direct and indirect laryngoscopy techniques, and a major reason for anesthesia-related adverse events. Over the past two decades, videolaryngoscopy has evolved to be the primary indirect laryngoscopy technique in a difficult endotracheal intubation setting. The possibility for optimal visualization of the laryngeal structures renders this method particularly helpful in patients with limited mouth opening. Especially videolaryngoscopy with acute-angle blades has been proposed to be favorable over conventional direct laryngoscopy in this setting. However, previous research has shown that a mouth opening of approximately 2.0 - 3.0 cm represents an independent risk factor and a possible critical lower limit for safe videolaryngoscopic intubation.
The latest generation of GlideScopeTM Spectrum blades may provide sufficient intubation conditions even in patients with a maximum mouth opening below 3.0 cm.
Our research group aims to evaluate the clinical performance, quality of larynx visualization and severity of videolaryngoscopic intubation the GlideScopeTM Spectrum system in patients with a small mouth opening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for non-cardiac surgery under general anesthesia with a need for endotracheal intubation presenting at the Anesthesiology Preassessment Clinic of the Hamburg University Hospital with a mouth opening between 1.0 and 3.0 cm within the recruiting period.
Key inclusion criteria (4 listed)
- Patients scheduled for non-cardiac surgery
- Required general anesthesia and endotracheal intubation
- Mouth opening between 1.0 and 3.0 cm (any reason) recognized during preoperative assessment
- Written consent provided
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Confirmed indication for awake fiberoptic intubation, especially due to enoral and pharyngeal tumors, abscesses or other obstructive lesions
- Endotracheal intubation planned without deep general anesthesia or without neuromuscular blockade (e.g. awake videolaryngoscopy)
- Qualification for rapid sequence anesthesia induction due to risk of pulmonary aspiration
- Loose teeth
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
Successful videolaryngoscopic endotracheal intubation rate
Time frame: Within 1 hour after anesthesia induction
Observation during airway management
5 secondary outcomes
First pass success rate
Time frame: Within 1 hour after anesthesia induction
Endotracheal intubation difficulty
Time frame: Within 1 hour after concluded endotracheal intubation
Best view obtained
Time frame: Within 1 hour after concluded endotracheal intubation
Intubation time
Time frame: Within 1 hour after anesthesia induction
Number of attempts
Time frame: Within 1 hour after anesthesia induction
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 24 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intubation;Difficult and Videolaryngoscopy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 4 inclusion and 5 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 24 Nov 2021. 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 Germany. 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?
Successful videolaryngoscopic endotracheal intubation rate (time frame: Within 1 hour after anesthesia induction). 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 24 Nov 2021.