Airway ManagementNCT04680169
I-gel vs AuraGain for Bronchoscopic Intubation Through SGA
A study testing Bronchoscopic intubation through AuraGain LMA and Bronchoscopic intubation through I-gel SGA in people with Airway Management, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
This trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- Bronchoscopic intubation through AuraGain LMA and Bronchoscopic intubation through I-gel SGA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jan 2021to 4 May 2021
- 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 scheduled for a non-acute ENT, gynaecological, gastrointestinal or orthopaedic surgical procedure for which general anaesthesia including oral intubation with an endotracheal tube will be provided
Who cannot join
- Age<18 years
- Inter-incisional distance <30mm
- Pregnant and BMI>40kg/m2
- ASA physical status classification system grade >3
- Earlier laryngeal or pharyngeal surgery
- Increased risk of aspiration (e.g. nasogastric tube inserted, planned Rapid Sequence Induction)
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- Informed consent cannot be obtained
- Patients with stridor
- Patients with hypoxemia defines by saturation <90 without oxygen at arrival to the operating room
- Use of oxygen supply at home
- Need of one of the following special endotracheal tubes for scheduled surgery: neural integrity monitor (NIM) electromyogram (EMG) tracheal tubes, wire tubes
- Patients scheduled for any awake approach to secure the airway e.g. awake videolaryngoscopy, awake fiberoptic bronchoscope intubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I-gel Versus AuraGain for Bronchoscopic Intubation Through Supraglottic Airway Device - a Randomized Controlled Trial
This trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use.
Read the detailed description
A prospective randomized controlled trial in the Department of Anesthesiology, Copenhagen University Hospital Nordsjællands Hospital-Hillerød Denmark. The study is approved by the Ethics Committee, capital region of Denmark. The aim of the study is to compare bronchoscopic tracheal intubation during continuous oxygenation through the AuraGain and I-gel supraglottic airway device. One hundred patients will be randomly allocated into two groups, group A (AuraGain) and group B (I-gel). Study outcomes are time to tracheal intubation confirmed by capnography as well as anesthesiologists reports of ease of use. Twenty-five anesthesiologists participates in this study, and are allocated four patient each. In random order, each physician will perform two bronchoscopic tracheal intubations with each SGA.
In the preoperative setting, a complete anesthetic evaluation will be performed, including a detailed airway assessment determining predictors for difficulties of face mask ventilation, insertion of SGA and tracheal intubation. Participants are scheduled to undergo elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with 100% oxygen. After induction, rocuronium 0.6mg/kg will be used to facilitate neuromuscular blockade. Sufficient face mask ventilation will be performed before intervention.
Group A: AuraGain:
Time is measured from when the anesthesiologist reaches for the AuraGain LMA until the mask is placed and adequate ventilation is confirmed by capnography. The AuraGain LMA will be used as conduit for bronchoscopic intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.
Group B: I-gel:
Time is measured from when the anesthesiologist reaches for the I-gel LMA until the mask is placed and adequate ventilation is confirmed by capnography.The I-gel LMA will be used as conduit for bronchoscopic tracheal intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.
In both groups (A and B) up to two attempts of SGA placement and up to three attempts of tracheal intubation are allowed.
In case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA placement, the difficult airway algorithm, DAS, UK will be followed. Video- assisted laryngoscopy will be the first option.
- Conditions
- Airway Management
- Being tested
- Bronchoscopic intubation through AuraGain LMA, Bronchoscopic intubation through I-gel SGA
- Keywords
- Intubation, Bronchoscopic, Supraglottic airway device, I-gel, AuraGain, Flexible, Fiberoptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopic intubation through AuraGain LMADevice
Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
Bronchoscopic intubation through I-gel SGADevice
Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| Group A: Bronchoscopic intubation using AuraGain LMA as conduit | Active comparator | A group of 50 patients randomly allocated to bronchoscopic intubation using AuraGain Receives: Device: Bronchoscopic intubation through AuraGain LMA |
| Group B: Bronchoscopic intubation with I-gel SGA as conduit | Active comparator | A group of 50 patients randomly allocated to bronchoscopic intubation using I-gel Receives: Device: Bronchoscopic intubation through I-gel SGA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time for airway management
Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography
Measured: Up to study completion, an average of 4 months
Secondary outcomes (4)
Time to placement of SGA
Time measured from reaching SGA with hands to correct placement of SGA confirmed by end of first curve on capnography
Measured: Up to study completion, an average of 4 months
Time to trans-device tracheal intubation
time measured from confirmed placement of SGA until successful tracheal intubation confirmed by end of first curve on capnography
Measured: Up to study completion, an average of 4 months
Number of attempts needed for correct placement of SGA
two attempts at correct placement allowed. Attempt is failed if no curve appears on capnography.
Measured: Up to study completion, an average of 4 months
Number of attempts needed for correct intubation
Attempt of bronchoscopic intubation begins when entering aScope in swivel. Attempt is failed if airway is not visualised, if tracheal tube can not be advanced in trachea, if SpO2 is <85% or if total time exceeds 6 minutes. Three attempts of intubation is allowed.
Measured: Up to study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start18 Jan 2021
- Primary completion4 May 2021
- Study completion4 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte V Rosenstock, Ph.d, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680169
- Sponsor's protocol ID
- Intubation through SGA
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-gel Versus AuraGain for Bronchoscopic Intubation Through Supraglottic Airway Device - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04680169
- Acronym / sponsor ID
- Intubation through SGA
- Conditions
- Airway Management
- Keywords
- Intubation, Bronchoscopic, Supraglottic airway device, I-gel, AuraGain, Flexible, Fiberoptic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 22 Dec 2020 (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 trial compares two different second generation supraglottic airway devices (AuraGain and I-gel) used as a conduit for bronchoscopic tracheal intubation during continuous oxygenation in order tο determine time to successful tracheal intubation and ease of use.
Detailed description
A prospective randomized controlled trial in the Department of Anesthesiology, Copenhagen University Hospital Nordsjællands Hospital-Hillerød Denmark. The study is approved by the Ethics Committee, capital region of Denmark. The aim of the study is to compare bronchoscopic tracheal intubation during continuous oxygenation through the AuraGain and I-gel supraglottic airway device. One hundred patients will be randomly allocated into two groups, group A (AuraGain) and group B (I-gel). Study outcomes are time to tracheal intubation confirmed by capnography as well as anesthesiologists reports of ease of use. Twenty-five anesthesiologists participates in this study, and are allocated four patient each. In random order, each physician will perform two bronchoscopic tracheal intubations with each SGA.
In the preoperative setting, a complete anesthetic evaluation will be performed, including a detailed airway assessment determining predictors for difficulties of face mask ventilation, insertion of SGA and tracheal intubation. Participants are scheduled to undergo elective surgery under general anesthesia. Before induction, all patients will be preoxygenated with 100% oxygen. After induction, rocuronium 0.6mg/kg will be used to facilitate neuromuscular blockade. Sufficient face mask ventilation will be performed before intervention.
Group A: AuraGain:
Time is measured from when the anesthesiologist reaches for the AuraGain LMA until the mask is placed and adequate ventilation is confirmed by capnography. The AuraGain LMA will be used as conduit for bronchoscopic intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.
Group B: I-gel:
Time is measured from when the anesthesiologist reaches for the I-gel LMA until the mask is placed and adequate ventilation is confirmed by capnography.The I-gel LMA will be used as conduit for bronchoscopic tracheal intubation during continuous oxygenation, and time is measured until placement of the tracheal tube verified by capnography.
In both groups (A and B) up to two attempts of SGA placement and up to three attempts of tracheal intubation are allowed.
In case of an emerging unpredicted difficult airway and a concurrent unsuccessful SGA placement, the difficult airway algorithm, DAS, UK will be followed. Video- assisted laryngoscopy will be the first option.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Bronchoscopic intubation using AuraGain LMA as conduit | Active comparator | Device: Bronchoscopic intubation through AuraGain LMAA group of 50 patients randomly allocated to bronchoscopic intubation using AuraGain |
| Group B: Bronchoscopic intubation with I-gel SGA as conduit | Active comparator | Device: Bronchoscopic intubation through I-gel SGAA group of 50 patients randomly allocated to bronchoscopic intubation using I-gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for a non-acute ENT, gynaecological, gastrointestinal or orthopaedic surgical procedure for which general anaesthesia including oral intubation with an endotracheal tube will be provided
Key exclusion criteria (12 listed)
- Age<18 years
- Inter-incisional distance <30mm
- Pregnant and BMI>40kg/m2
- ASA physical status classification system grade >3
- Earlier laryngeal or pharyngeal surgery
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 |
|---|---|---|
| Bronchoscopic intubation through AuraGain LMAComparing two different SGAs as conduit for bronchoscopic tracheal intubation | Device | Group A: Bronchoscopic intubation using AuraGain LMA as conduit |
| Bronchoscopic intubation through I-gel SGAComparing two different SGAs as conduit for bronchoscopic tracheal intubation | Device | Group B: Bronchoscopic intubation with I-gel SGA as conduit |
Primary outcome
Total time for airway management
Time frame: Up to study completion, an average of 4 months
Total time from reaching the SGA with hands to ended bronchoscopic tracheal intubation confirmed by the end of first curve on capnography
4 secondary outcomes
Time to placement of SGA
Time frame: Up to study completion, an average of 4 months
Time to trans-device tracheal intubation
Time frame: Up to study completion, an average of 4 months
Number of attempts needed for correct placement of SGA
Time frame: Up to study completion, an average of 4 months
Number of attempts needed for correct intubation
Time frame: Up to study completion, an average of 4 months
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 21 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Charlotte V Rosenstock, Ph.d principal investigator
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopic intubation through AuraGain LMA and Bronchoscopic intubation through I-gel SGA in people with Airway Management, run by Nordsjaellands Hospital at 1 site in Denmark.
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 12 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 21 Jun 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 Denmark. 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?
Total time for airway management (time frame: Up to study completion, an average of 4 months). 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 Jun 2021.