Supraglottic AirwayNCT01656967
AMBU AScope2 Fiberoptic Intubation Versus Fastrach Intubating LMA
A study testing AMBU Aura-I/aScope 2 and LMA Fastrach Single Use in people with Supraglottic Airway, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraglottic Airway
- What is being tested?
- AMBU Aura-I/aScope 2 and LMA Fastrach Single Use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult surgical Candidates Aged 18-80 years
- ASA I-III
- Mallampati Score of I or II
- BMI ≤ 35 kg/m2
- Presenting for elective surgery
- Require General Endotracheal Anesthesia.
Who cannot join
- Previously known difficult airway,
- Emergency status
- Require prone positioning
- Interincisor distance < 2.5cm
- Thyromental distance < 5cm
- Clinically suspected difficult airway
Show all 9Show fewer
- Contraindications to LMA Insertion, such as Reflux disease
- Patients who do not require endotracheal intubation
- Indications for Rapid Sequence Induction (RSI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, 77030
About this study
Official title: Flexible Optical Intubation Via the AMBU Aura-I Versus Blind Intubation Via the Fastrach Single Use Intubating LMA - A Prospective Randomized Clinical Trial
The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in patients undergoing general anesthesia for elective surgery.
Read the detailed description
The study will include a total of 66 patients. Patients will be randomized into 2 groups through a computer generated randomization schedule. Patients in group A (N= 30) will be intubated using Ambu Aura-I and the Ambu aScope and patients in group B (N= 30) will be intubated using Intubating LMA. Patients will only be tested with one device.In the operating room, standard monitoring devices will be applied including a pulse oximeter, 3 lead (at least) ECG and blood pressure cuff; the latter could be invasive or non-invasive depending on the nature of the surgery. Baseline measures of BP, pulse, oxygen saturation, and CO2 will be made. The time will be noted before any sedation or anesthesia is administered. Vital signs will be recorded after induction of anesthesia, after insertion of SGA, and again after successful intubation.
General anesthesia will be induced by bolus administration of propofol (1.5 to 2mg/kg) and fentanyl (1mcg/kg), and maintained with an inhalational agent. Rocuronium (0.6 mg/kg) will be administered to provide muscle relaxation and a mixture of sevoflurane or isoflurane and nitrous oxide will be utilized for maintenance of anesthesia once the ability to mask ventilate is confirmed. The lungs will be mechanically ventilated with a semi-closed circle system to maintain an end-tidal CO2 near 35 mmHg. Patients' lungs will be ventilated via anesthesia mask 100% oxygen until the patient is completely relaxed.
The size of the SGA device used will be based on manufacturer's recommendations and clinical evaluation of the anesthesiologist. The SGA device will be placed using standard technique and jaw lift will always be performed to aid in placement. The user will record ease of insertion on a scale (1-5) and number of insertions required will also be recorded. A new attempt is considered to begin if the tip of the cuff is withdrawn to the level of the lips. Accurate ventilation is achieved when the CO2 signal is rectangular and the mask is airtight at a respiratory pressure of up to 20 cm H2O. Time will be recorded from when the tip of the device cuff is at the mouth opening and stopped when first CO2 waveform is recorded.
Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope. If the epiglottis is down folded and obscuring optical view, jaw lift can be performed by an assistant to improve visualization of the cords. The aScope will be advanced until the carina is visualized and then the ETT is railroaded via the aScope into position (5cm above carina or cuff of ETT just below vocal cords). Once the ETT is successfully inserted, the cuff of the Aura-I will be deflated and the patient is ventilated via the ETT. If it is not possible to intubate, the ETT should be rotated 90° counterclockwise and jaw lift should be performed to help with intubation. If unsuccessful after two attempts, the anesthesiologist will proceed to intubate in standard fashion. The patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure.
Once the procedure has finished and the patient is adequately reversed as determined by nerve stimulation, the cuff will be reinflated and the ETT will be removed. Ventilation will resume via the SGA. Once the ETT is withdrawn, the cuff will be adjusted to 60cm H2O using a cuff pressure manometer. The oropharyngeal leak pressure(OLP) is determined with a 60 cm H2O intracuff pressure by closing the expiratory spill valve and then closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min, without any respiration. The airway pressure at which equilibrium is reached and air leaks from the mouth or into the stomach, as sign of leak of the laryngeal mask is noted. Esophageal leak is determined by stethoscopy of the epigastrium and oropharyngeal leak is dectected listening for air leak over the mouth.
The peak airway pressure is not allowed to exceed 40 cmH2O. After OLP measurement and once the patient is adequately breathing on their own, the SGA can be removed.
- Conditions
- Supraglottic Airway
- Being tested
- AMBU Aura-I/aScope 2, LMA Fastrach Single Use
- Keywords
- Laryngeal Mask Airway, LMA, Intubation, AMBU, AScope, Aura-I, Fastrach, Fiberoptic, Disposable Fiberoptic, Blind Intubation, Fiberoptic Intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMBU Aura-I/aScope 2Device
Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope.
LMA Fastrach Single UseDevice
The patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure.
| Study group | Role | What they receive |
|---|---|---|
| AMBU Aura-I/aScope 2 | Experimental | First, the AMBU Aura-I LMA will be inserted. Then, the patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system. Receives: Device: AMBU Aura-I/aScope 2 |
| LMA Fastrach | Experimental | The LMA Fastrach Single Use Laryngeal Mask Airway will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube. Receives: Device: LMA Fastrach Single Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Intubation Time
Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.
Measured: Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion
Secondary outcomes (8)
Time for Supraglottic Airway (SGA) Insertion
Time for SGA insertion was measured from when the tip of the cuff was at the mouth to detection of CO2 on the capnogram.
Measured: At SGA insertion
Time for Endotracheal Tube (ETT) Insertion
After the SGA is inserted, time for intubation will be recorded. Time for ETT insertion was measured, for arm 1, from when the AMBU aScope is at the connector level of the Aura-I or, for arm 2, from when the ETT is at the connector level of the Intubating LMA to first detection of CO2 on the capnogram. The AScope 2 disposable fiberoptic camera will be used to assist with intubation for Group 1 patients. Group 2 patients will be intubated using the LMA-Fastrach EndoTracheal Tube.
Measured: At ETT insertion
Number of Participants in Whom SGA Insertion Was Successful on the First Attempt
Measured: At SGA insertion
Number of Participants in Whom ETT Insertion Was Successful on the First Attempt
Measured: At ETT insertion
Number of Participants With Overall Success for SGA Placement
Ease of SGA insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).
Measured: At SGA insertion
Number of Participant With Overall Intubation Success
Ease of ETT insertion is subjectively assessed by the operator on a scale from 1 to 5 (1 = extremely easy, 5 = extremely difficult).
Measured: At ETT insertion
Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)
The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.
Measured: Within 30 minutes of completion of surgery
Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)
The patient will be assessed for Post-Operative Hoarseness, Sore Mouth, Sore Neck, Sore Jaw, Dysphonia, Dysphagia, and Altered Tongue Sensation.
Measured: Approximately 1-2 hours after entering the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Supraglottic AirwayStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ambu A/S
- Responsible party
- Principal investigator, Carin A. Hagberg, The University of Texas Health Science Center, Houston
- Investigators
- Carin A Hagberg, MD, Principal investigator, The University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656967
- Sponsor's protocol ID
- HSC-MS-10-0604
- Status last verified
- Oct 2018
- First submitted
- 30 Jul 2012
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Optical Intubation Via the AMBU Aura-I Versus Blind Intubation Via the Fastrach Single Use Intubating LMA - A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01656967
- Acronym / sponsor ID
- HSC-MS-10-0604
- Conditions
- Supraglottic Airway
- Keywords
- Laryngeal Mask Airway, LMA, Intubation, AMBU, AScope, Aura-I, Fastrach, Fiberoptic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Posted 22 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two types of supraglottic airways (SGA), the Ambu® Aura-I and the Intubating Laryngeal Mask Airway (ILMA), regarding time to intubate, ease of insertion, sealing properties, optical view upon fiberoptic examination regarding the Ambu Aura-I, ease and success rate of intubation, airway morbidity, and patient comfort in patients undergoing general anesthesia for elective surgery.
Detailed description
The study will include a total of 66 patients. Patients will be randomized into 2 groups through a computer generated randomization schedule. Patients in group A (N= 30) will be intubated using Ambu Aura-I and the Ambu aScope and patients in group B (N= 30) will be intubated using Intubating LMA. Patients will only be tested with one device.In the operating room, standard monitoring devices will be applied including a pulse oximeter, 3 lead (at least) ECG and blood pressure cuff; the latter could be invasive or non-invasive depending on the nature of the surgery. Baseline measures of BP, pulse, oxygen saturation, and CO2 will be made. The time will be noted before any sedation or anesthesia is administered. Vital signs will be recorded after induction of anesthesia, after insertion of SGA, and again after successful intubation.
General anesthesia will be induced by bolus administration of propofol (1.5 to 2mg/kg) and fentanyl (1mcg/kg), and maintained with an inhalational agent. Rocuronium (0.6 mg/kg) will be administered to provide muscle relaxation and a mixture of sevoflurane or isoflurane and nitrous oxide will be utilized for maintenance of anesthesia once the ability to mask ventilate is confirmed. The lungs will be mechanically ventilated with a semi-closed circle system to maintain an end-tidal CO2 near 35 mmHg. Patients' lungs will be ventilated via anesthesia mask 100% oxygen until the patient is completely relaxed.
The size of the SGA device used will be based on manufacturer's recommendations and clinical evaluation of the anesthesiologist. The SGA device will be placed using standard technique and jaw lift will always be performed to aid in placement. The user will record ease of insertion on a scale (1-5) and number of insertions required will also be recorded. A new attempt is considered to begin if the tip of the cuff is withdrawn to the level of the lips. Accurate ventilation is achieved when the CO2 signal is rectangular and the mask is airtight at a respiratory pressure of up to 20 cm H2O. Time will be recorded from when the tip of the device cuff is at the mouth opening and stopped when first CO2 waveform is recorded.
Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope. If the epiglottis is down folded and obscuring optical view, jaw lift can be performed by an assistant to improve visualization of the cords. The aScope will be advanced until the carina is visualized and then the ETT is railroaded via the aScope into position (5cm above carina or cuff of ETT just below vocal cords). Once the ETT is successfully inserted, the cuff of the Aura-I will be deflated and the patient is ventilated via the ETT. If it is not possible to intubate, the ETT should be rotated 90° counterclockwise and jaw lift should be performed to help with intubation. If unsuccessful after two attempts, the anesthesiologist will proceed to intubate in standard fashion. The patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure.
Once the procedure has finished and the patient is adequately reversed as determined by nerve stimulation, the cuff will be reinflated and the ETT will be removed. Ventilation will resume via the SGA. Once the ETT is withdrawn, the cuff will be adjusted to 60cm H2O using a cuff pressure manometer. The oropharyngeal leak pressure(OLP) is determined with a 60 cm H2O intracuff pressure by closing the expiratory spill valve and then closing the expiratory valve of the circle system at a fixed gas flow of 3 L/min, without any respiration. The airway pressure at which equilibrium is reached and air leaks from the mouth or into the stomach, as sign of leak of the laryngeal mask is noted. Esophageal leak is determined by stethoscopy of the epigastrium and oropharyngeal leak is dectected listening for air leak over the mouth.
The peak airway pressure is not allowed to exceed 40 cmH2O. After OLP measurement and once the patient is adequately breathing on their own, the SGA can be removed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMBU Aura-I/aScope 2 | Experimental | Device: AMBU Aura-I/aScope 2First, the AMBU Aura-I LMA will be inserted. Then, the patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system. |
| LMA Fastrach | Experimental | Device: LMA Fastrach Single UseThe LMA Fastrach Single Use Laryngeal Mask Airway will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult surgical Candidates Aged 18-80 years
- ASA I-III
- Mallampati Score of I or II
- BMI ≤ 35 kg/m2
- Presenting for elective surgery
Key exclusion criteria (9 listed)
- Previously known difficult airway,
- Emergency status
- Require prone positioning
- Interincisor distance < 2.5cm
- Thyromental distance < 5cm
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 Aura-I/aScope 2Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope. | Device | AMBU Aura-I/aScope 2 |
| LMA Fastrach Single UseThe patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure. | Device | LMA Fastrach |
Primary outcome
Total Intubation Time
Time frame: Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion
Total Intubation Time includes time for SGA insertion and for ETT insertion. The total time to intubation was measured from the beginning of SGA insertion to successful endotracheal tube intubation verified by detection of CO2 on the capnogram.
8 secondary outcomes
Time for Supraglottic Airway (SGA) Insertion
Time frame: At SGA insertion
Time for Endotracheal Tube (ETT) Insertion
Time frame: At ETT insertion
Number of Participants in Whom SGA Insertion Was Successful on the First Attempt
Time frame: At SGA insertion
Number of Participants in Whom ETT Insertion Was Successful on the First Attempt
Time frame: At ETT insertion
Number of Participants With Overall Success for SGA Placement
Time frame: At SGA insertion
Number of Participant With Overall Intubation Success
Time frame: At ETT insertion
Post-Operative Discomfort Upon Entering the Post-Anesthesia Care Unit (PACU)
Time frame: Within 30 minutes of completion of surgery
Post-Operative Discomfort Upon Leaving the Post-Anesthesia Care Unit (PACU)
Time frame: Approximately 1-2 hours after entering the PACU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Carin A Hagberg, MD principal investigator
The University of Texas Medical School at Houston
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 Aura-I/aScope 2 and LMA Fastrach Single Use in people with Supraglottic Airway, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 6 inclusion and 9 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 8 Nov 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Intubation Time (time frame: Duration of Intubation, including supraglottic airway (SGA) insertion and endotracheal tube (ETT) insertion). 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 8 Nov 2018.