Intubation; Difficult or FailedNCT03408431
Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™
A study testing Ambu® AuraGain™ and neck extension in people with Intubation; Difficult or Failed and Intubation Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In a previous study, NCT03147469, the investigators found that the vocal cords were more easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of this finding, the investigators are going to conduct a randomized controlled trial to evaluate the effect of neck extension on the… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Intubation; Difficult or Failed, Intubation Complication
- What is being tested?
- Ambu® AuraGain™ and neck extension
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jan 2018to 1 May 2018
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing general anesthesia with endotracheal intubation
Who cannot join
- Emergency operation
- History of esophageal, oropharyngeal, or laryngeal disease
- History of cervical spine surgery
- Insufficient NPO time
- Loosening teeth
- Mouth opening less than 2cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™ Laryngeal Mask: a Randomized Controlled Trial
In a previous study, NCT03147469, the investigators found that the vocal cords were more easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of this finding, the investigators are going to conduct a randomized controlled trial to evaluate the effect of neck extension on the success rate of blind intubation through laryngeal mask.
Participants undergoing general anesthesia will be randomly assigned to group E (with neck extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if blind intubation succeed. Blind intubation will be performed with a maximum of two attempts. If all attempts failed, the laryngeal mask will be removed and the tube will be intubated using a direct laryngoscopy.
The primary outcome of this study is the success rate of blind intubation within a first attempt. Secondary outcomes included overall success rate of blind intubation within a maximum of two attempts, time for blind intubation, the incidence of postoperative hoarseness, cough, and sore throat, and any obvious complications related to airway management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.
- Being tested
- Ambu® AuraGain™, neck extension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu® AuraGain™Device
Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask under each position according to the assigned group.
neck extensionProcedure or surgery
Patients' neck will be maximally extended (~60°) during blind intubation.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Experimental | After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning. Receives: Device: Ambu® AuraGain™; Procedure: neck extension |
| Group C | Active comparator | After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neutral head and neck position. Receives: Device: Ambu® AuraGain™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate in first attempt
Successful blind intubation in a first attempt
Measured: In a first attempt for blind intubation, an average of 30 seconds
Secondary outcomes (5)
Overall success rate
Successful blind intubation within a maximum of two attempts
Measured: In a maximum of two attempts for blind intubation, an average of 60 seconds
Time for blind intubation
Time between insertion of an endotracheal tube within the laryngeal mask and detection of end-tidal CO2 from the tube
Measured: In a maximum of two attempts for blind intubation, an average of 60 seconds
Postoperative hoarseness
The incidence of postoperative hoarseness
Measured: 24 hours after extubation
Postoperative cough
The incidence of postoperative cough
Measured: 24 hours after extubation
Postoperative sore throat
The incidence of postoperative sore throat
Measured: 24 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start25 Jan 2018
- Primary completion30 Apr 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408431
- Sponsor's protocol ID
- H-1709-123-890
- Status last verified
- May 2018
- First submitted
- 10 Jan 2018
- Last updated
- 3 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoo S, Park SK, Kim WH, Hur M, Bahk JH, Lim YJ, Kim JT. The effect of neck extension on success rate of blind intubation through Ambu(R) AuraGain laryngeal mask: a randomized clinical trial. Can J Anaesth. 2019 Jun;66(6):639-647. doi: 10.1007/s12630-019-01353-4. Epub 2019 Mar 27.
PubMed 30919236
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Neck Extension on Blind Intubation Via Ambu® AuraGain™ Laryngeal Mask: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03408431
- Acronym / sponsor ID
- H-1709-123-890
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 24 Jan 2018 (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.
In a previous study, NCT03147469, the investigators found that the vocal cords were more easily visualized by fiberoptic bronchoscopy with neck extension positioning. On the basis of this finding, the investigators are going to conduct a randomized controlled trial to evaluate the effect of neck extension on the success rate of blind intubation through laryngeal mask.
Participants undergoing general anesthesia will be randomly assigned to group E (with neck extension) or group C (with neutral position). Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask. The participants will be mechanically ventilated with an endotracheal tube if blind intubation succeed. Blind intubation will be performed with a maximum of two attempts. If all attempts failed, the laryngeal mask will be removed and the tube will be intubated using a direct laryngoscopy.
The primary outcome of this study is the success rate of blind intubation within a first attempt. Secondary outcomes included overall success rate of blind intubation within a maximum of two attempts, time for blind intubation, the incidence of postoperative hoarseness, cough, and sore throat, and any obvious complications related to airway management such as bleeding, airway trauma, dental fracture, aspiration, or bronchospasm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group E | Experimental | Device: Ambu® AuraGain™, Procedure: neck extensionAfter the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neck extension positioning. |
| Group C | Active comparator | Device: Ambu® AuraGain™After the placement of Ambu® AuraGain™, blind intubation will be performed in patients assigned group E with neutral head and neck position. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing general anesthesia with endotracheal intubation
Key exclusion criteria (6 listed)
- Emergency operation
- History of esophageal, oropharyngeal, or laryngeal disease
- History of cervical spine surgery
- Insufficient NPO time
- Loosening teeth
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 |
|---|---|---|
| Ambu® AuraGain™Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask under each position according to the assigned group. | Device | Group C, Group E |
| neck extensionPatients' neck will be maximally extended (~60°) during blind intubation. | Procedure or surgery | Group E |
Primary outcome
Success rate in first attempt
Time frame: In a first attempt for blind intubation, an average of 30 seconds
Successful blind intubation in a first attempt
5 secondary outcomes
Overall success rate
Time frame: In a maximum of two attempts for blind intubation, an average of 60 seconds
Time for blind intubation
Time frame: In a maximum of two attempts for blind intubation, an average of 60 seconds
Postoperative hoarseness
Time frame: 24 hours after extubation
Postoperative cough
Time frame: 24 hours after extubation
Postoperative sore throat
Time frame: 24 hours after extubation
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 3 May 2018.
- Derived from this study: PubMed 30919236Yoo S, Park SK, Kim WH, Hur M, Bahk JH, Lim YJ, Kim JT. The effect of neck extension on success rate of blind intubation through Ambu(R) AuraGain laryngeal mask: a randomized clinical trial. Can J Anaesth. 2019 Jun;66(6):639-647. doi: 10.1007/s12630-019-01353-4. Epub 2019 Mar 27.
- Individual participant dataSharing planned: Undecided
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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.
Jin-Tae Kim, PhD. principal investigator
Seoul National University 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 Ambu® AuraGain™ and neck extension in people with Intubation; Difficult or Failed and Intubation Complication, run by Seoul National University Hospital at 1 site in South Korea.
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 6 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 3 May 2018. 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 South Korea. 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?
Success rate in first attempt (time frame: In a first attempt for blind intubation, an average of 30 seconds). 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 NCT03408431, which also lists 1 linked publication.
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 3 May 2018.