General AnesthesiaNCT02002364
Comparison of a Single Use (Ambu aScope) and a Reusable Flexible Optical Scope for Intubation Through a Supraglottic Airway Device (Aura-i)
A study testing tracheal intubation in people with General Anesthesia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
Trial summary
In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- tracheal intubation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2013to Dec 2014
- 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
- ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
- The patient must have one or two of the following predictors of difficult tracheal intubation:
- Modified Mallampati score > 2 (= "no parts of the Uvula is visible")
- a thyromental distance of less then or equal to 6.5 cms
- Combined movement in head and neck < 90 degrees
- Mouth-opening less the 4 cm (but must be larger then 2.5 cm)
Show all 10Show fewer
- Inability to protrude the teeth n the lower jaw beyond the upper incisors
- BMI > 40 combined with a neck-circumference > 43 cms
- Upper-lip-bite-test > 2
- Previous difficult intubation or laryngoscopy (If more then two criteria are fulfilled the patient should be considered intubated awake instead. . But the upper-lip-bite-test and the prognation-beyond the incisors test represents a similar thing, namely the inability to sub-luxate the lower jaw, the if both these findings are positive it is only considered as counting for one.
Who cannot join
- ASA physical status 4 or 5
- contraindications for use of the SAD
- Patients in whom intubation via a SAD has previously failed
- Patients at risk of aspiration from the gastrointestinal channel
- diseases in mouth, pharynx or larynx that precludes the use of a SAD
- Patients in whom the cricothyroid membrane cannot be localized preanaesthetically
- Patients in whom the doctor making the pre-anaesthetic evaluation finds in need of an awake intubation
- Patients with possible Creutzfeldt-Jacobs disease or contraindication against the use of non-autoclavable equipment r risk of cross contamination with prions
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, Denmark
Copenhagen, 2100
Michael S Kristensen, M.D., 0045 3445 8033, michael.seltz.kristensen@regionh.dk
Michael S Kristensen, M.D.
France1 site, 1 recruiting
- Not yet recruiting
Service d'anesthesie-reanimation 1 avenue Moliere Hopiatl de Hautepierre
Strasbourg, 67098
Pierre Diemunsch, M.D., 0033 3 88 12 70 76, pierre.diemunsch@chrustrasbourg.fr
Pierre Diemunsch, M.D.
About this study
Official title: A Comparison Between Flexible Single Use Endoscopes (Ambu aScopes) and Reusable Flexible Endoscopes Used as a Standard of Car When Intubation the Trachea Via an Aura-I Supraglottic Airway Device
In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.
We hypothesize that intubation is obtained equally effective with both types of flexible scopes
- Conditions
- General Anesthesia
- Being tested
- tracheal intubation
- Keywords
- tracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal intubationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single use flexible optical scope | Active comparator | Single use flexible optical scope , Ambu aScope Receives: Procedure: tracheal intubation |
| Multiple use flexible optical scope | Active comparator | Multiple use flexible optical scope Receives: Procedure: tracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
Measured: Measured during tracheal intubation at induction of anesthesia
Secondary outcomes (9)
Number of attempts at placing the supraglottic-airway-device (SAD)
an attempt is defined as the tip of the SAD passing the upper front teeth
Measured: From anesthesia induction and the following 10 minutes during securing of the airway
number of attempts at placing the flexible endoscope in the trachea
Measured: From anesthesia induction and the following 10 minutes
number of attempts at intubation
An intubation attempt starts when the tip of the endotracheal tube passes the entrance to the SAD
Measured: From anesthesia induction and during the following 10 minutes during airway management
Total time for placement of SAD and endoscopy and intubation
Measured: During induction of anesthesia and the following 10 minutes during airway management
The best glottic view obtained
Measured: After anesthesia induction and during the following 10 minutes during airway management
The ease of passage of the flexible endoscope via the SAD
Measured: During induction and airway management
The anesthesiologists' satisfaction with the procedure
Measured: During induction of anesthesia and within the 30 minutes hereafter
The quality of the endoscopically obtained image
Measured: During induction of anesthesia and the following 10 minutes during airway management
Postoperative sore throat, dysphonia or dysphagia one hour after extubation
Measured: AT the time 1 hour after extubation of the trachea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Ambu A/S
- Responsible party
- Principal investigator, Michael Seltz Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael S Kristensen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002364
- Sponsor's protocol ID
- Journal nr. H-3-2012-001
- Status last verified
- May 2014
- First submitted
- 24 Nov 2013
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Flexible Single Use Endoscopes (Ambu aScopes) and Reusable Flexible Endoscopes Used as a Standard of Car When Intubation the Trachea Via an Aura-I Supraglottic Airway Device
- ClinicalTrials.gov ID
- NCT02002364
- Acronym / sponsor ID
- Journal nr. H-3-2012-001
- Conditions
- General Anesthesia
- Keywords
- tracheal intubation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 5 Dec 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.
In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.
We hypothesize that intubation is obtained equally effective with both types of flexible scopes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single use flexible optical scope | Active comparator | Procedure: tracheal intubationSingle use flexible optical scope , Ambu aScope |
| Multiple use flexible optical scope | Active comparator | Procedure: tracheal intubationMultiple use flexible optical scope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
- The patient must have one or two of the following predictors of difficult tracheal intubation:
Key exclusion criteria (8 listed)
- ASA physical status 4 or 5
- contraindications for use of the SAD
- Patients in whom intubation via a SAD has previously failed
- Patients at risk of aspiration from the gastrointestinal channel
- diseases in mouth, pharynx or larynx that precludes the use of a SAD
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 |
|---|---|---|
| tracheal intubation | Procedure or surgery | Multiple use flexible optical scope, Single use flexible optical scope |
Primary outcome
Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen
Time frame: Measured during tracheal intubation at induction of anesthesia
9 secondary outcomes
Number of attempts at placing the supraglottic-airway-device (SAD)
Time frame: From anesthesia induction and the following 10 minutes during securing of the airway
number of attempts at placing the flexible endoscope in the trachea
Time frame: From anesthesia induction and the following 10 minutes
number of attempts at intubation
Time frame: From anesthesia induction and during the following 10 minutes during airway management
Total time for placement of SAD and endoscopy and intubation
Time frame: During induction of anesthesia and the following 10 minutes during airway management
The best glottic view obtained
Time frame: After anesthesia induction and during the following 10 minutes during airway management
The ease of passage of the flexible endoscope via the SAD
Time frame: During induction and airway management
The anesthesiologists' satisfaction with the procedure
Time frame: During induction of anesthesia and within the 30 minutes hereafter
The quality of the endoscopically obtained image
Time frame: During induction of anesthesia and the following 10 minutes during airway management
Postoperative sore throat, dysphonia or dysphagia one hour after extubation
Time frame: AT the time 1 hour after extubation of the trachea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
Michael S Kristensen principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tracheal intubation in people with General Anesthesia, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
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 10 inclusion and 8 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 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, France. 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 Michael S Kristensen, M.D. (0045 35458033, michael.seltz.kristensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of intubation. From the endoscope enters the supraglottic-airway-device to CO2-curve is seen (time frame: Measured during tracheal intubation at induction of anesthesia). 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 21 May 2014.