Intubation, EndotrachealPhase 4NCT00272194
Ambu® Laryngeal Mask as an Intubation Conduit
A Phase 4 study testing Ambu Laryngeal Mask, Aintree Exchange Catheter and Laryngeal Mask Airway in people with Intubation, Endotracheal, 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 determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intubation, Endotracheal
- What is being tested?
- Ambu Laryngeal Mask, Aintree Exchange Catheter and Laryngeal Mask Airway
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Apr 2007
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is ASA 1-3 presenting for an elective surgical procedure
- The patient is 18-65 years of age
- The patient weighs > 50 kg with a BMI < 30 kg/m2
- The patient has a Mallampati grade I -III airway
- The patient is undergoing general anesthesia with controlled ventilation for minor routine surgical procedures
- The period of anesthesia time is >30 minutes
Who cannot join
- The patient is an ASA classification 4
- The patient is < 18 or >65 years of age
- The patient weighs < 50 kg or has a BMI > 30 kg/m2
- The patient has a history of inadequate cervical mobility
- The patient has a history or signs of difficult airway management
- The patient has a Mallampati grade IV Class airway
Show all 12Show fewer
- The patient has a mouth opening < 2.5 cm
- The patient has an oral cavity disease
- The patient has a cervical malformation
- The patient had upper respiratory tract symptoms in the previous 10 days
- The patient is to have surgery performed to the head/neck or thoracoabdominal cavities needing to be paralyzed, or in the lateral/prone position
- The patient is considered at risk of aspiration (non-fasted, gastroesophageal reflux/disease)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ambu® Laryngeal Mask as an Intubation Conduit For Patients Undergoing Routine General Anesthesia
The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.
Read the detailed description
The laryngeal mask airway (LMA) is an established supra-glottic device that provides better ventilation than traditional mask ventilation and is less invasive than endotracheal intubation. Being less invasive, it is commonly used for short elective surgical procedures. Its ability to be both easily and rapidly inserted also makes it useful as a rescue device in difficult and failed intubations. Being a supra-glottic device, the LMA does not protect patients from regurgitation and aspiration. Additionally, patients requiring alternative positions, such as prone or lateral, or those having surgery in the neck/head area are contra-indicated for LMA use due to risk of possible movement of the LMA, and therefore possible loss of airway patency. Thus, the LMA can be utilized as an intermediary method of airway management to endotracheal intubation.
The manufacturer of the reusable LMA-ClassicTM states that "the success rate of intubation through the standard LMA-ClassicTM is highly variable (30-93%)," whereas the success rate of the disposable version, LMA-UniqueTM, has been found to be only 21%1. An LMA specifically designed for intubation now exists and improves the success rate of intubation. The reusable LMA-FastrachTM or Intubating-LMATM (ILMA) is a rigid and anatomically curved airway tube. It is wide enough to accommodate 8.0 mm cuffed endotracheal tubes. Attached to the ILMA is a rigid handle to aid in one-handed insertion, removal, and adjustment. Success rates for intubating through the ILMA are 96.5% when inserted blindly and 100% with fiberoptic guidance2. No disposable version of the ILMA presently exists.
The Ambu® Laryngeal Mask (ALMA) is a new disposable laryngeal mask with an anatomical curve similar to the ILMA. The reasons for the use of disposable products can be many and varied. The residual risk of the transmission of germs and protein particles represents one indication. If supra-glottic airway devices are used electively or in emergencies, e.g. for HIV-positive patients or those infected with Creutzfeldt-Jacob disease, reuse of the products is not desirable. Disposable products, on the other hand, offer the benefit that the transmission of germs is avoided, and at the same time offer considerable economic advantages due to the much lower price of the product. The disposable ALMA has been proven as an effective and safe supra-glottic airway device3. Upon fiberoptic visualization through its shaft, the glottis was visualized 91.5% of the time, indicating that this device may be used as an intubation conduit. The purpose of this study is to determine if the ALMA is also safe and effective as an intubating conduit. The hypothesis is that the ALMA will perform as well as, if not better than the LMA-UniqueTM.
- Conditions
- Intubation, Endotracheal
- Being tested
- Ambu Laryngeal Mask, Aintree Exchange Catheter, Laryngeal Mask Airway
- Keywords
- Endotracheal Intubation, Supraglottic Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu Laryngeal MaskDevice
Aintree Exchange CatheterDevice
Laryngeal Mask AirwayDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and arytenoids
Secondary outcomes (1)
vital signs, oxygen saturation, end-tidal carbon dioxide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startDec 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, EndotrachealStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 160 participants
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, M.D., Principal investigator, The University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272194
- Sponsor's protocol ID
- HSC-MS-05-0347
- Status last verified
- Mar 2016
- First submitted
- 2 Jan 2006
- Last updated
- 23 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ambu® Laryngeal Mask as an Intubation Conduit For Patients Undergoing Routine General Anesthesia
- ClinicalTrials.gov ID
- NCT00272194
- Acronym / sponsor ID
- HSC-MS-05-0347
- Conditions
- Intubation, Endotracheal
- Keywords
- Endotracheal Intubation, Supraglottic Airway
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- Dec 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 4 Jan 2006 (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.
The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.
Detailed description
The laryngeal mask airway (LMA) is an established supra-glottic device that provides better ventilation than traditional mask ventilation and is less invasive than endotracheal intubation. Being less invasive, it is commonly used for short elective surgical procedures. Its ability to be both easily and rapidly inserted also makes it useful as a rescue device in difficult and failed intubations. Being a supra-glottic device, the LMA does not protect patients from regurgitation and aspiration. Additionally, patients requiring alternative positions, such as prone or lateral, or those having surgery in the neck/head area are contra-indicated for LMA use due to risk of possible movement of the LMA, and therefore possible loss of airway patency. Thus, the LMA can be utilized as an intermediary method of airway management to endotracheal intubation.
The manufacturer of the reusable LMA-ClassicTM states that "the success rate of intubation through the standard LMA-ClassicTM is highly variable (30-93%)," whereas the success rate of the disposable version, LMA-UniqueTM, has been found to be only 21%1. An LMA specifically designed for intubation now exists and improves the success rate of intubation. The reusable LMA-FastrachTM or Intubating-LMATM (ILMA) is a rigid and anatomically curved airway tube. It is wide enough to accommodate 8.0 mm cuffed endotracheal tubes. Attached to the ILMA is a rigid handle to aid in one-handed insertion, removal, and adjustment. Success rates for intubating through the ILMA are 96.5% when inserted blindly and 100% with fiberoptic guidance2. No disposable version of the ILMA presently exists.
The Ambu® Laryngeal Mask (ALMA) is a new disposable laryngeal mask with an anatomical curve similar to the ILMA. The reasons for the use of disposable products can be many and varied. The residual risk of the transmission of germs and protein particles represents one indication. If supra-glottic airway devices are used electively or in emergencies, e.g. for HIV-positive patients or those infected with Creutzfeldt-Jacob disease, reuse of the products is not desirable. Disposable products, on the other hand, offer the benefit that the transmission of germs is avoided, and at the same time offer considerable economic advantages due to the much lower price of the product. The disposable ALMA has been proven as an effective and safe supra-glottic airway device3. Upon fiberoptic visualization through its shaft, the glottis was visualized 91.5% of the time, indicating that this device may be used as an intubation conduit. The purpose of this study is to determine if the ALMA is also safe and effective as an intubating conduit. The hypothesis is that the ALMA will perform as well as, if not better than the LMA-UniqueTM.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is ASA 1-3 presenting for an elective surgical procedure
- The patient is 18-65 years of age
- The patient weighs > 50 kg with a BMI < 30 kg/m2
- The patient has a Mallampati grade I -III airway
- The patient is undergoing general anesthesia with controlled ventilation for minor routine surgical procedures
Key exclusion criteria (12 listed)
- The patient is an ASA classification 4
- The patient is < 18 or >65 years of age
- The patient weighs < 50 kg or has a BMI > 30 kg/m2
- The patient has a history of inadequate cervical mobility
- The patient has a history or signs of difficult airway management
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 Laryngeal Mask | Device | – |
| Aintree Exchange Catheter | Device | – |
| Laryngeal Mask Airway | Device | – |
Primary outcome
Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and arytenoids
1 secondary outcome
vital signs, oxygen saturation, end-tidal carbon dioxide
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 23 Mar 2016.
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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, M.D. 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 Phase 4 study testing Ambu Laryngeal Mask, Aintree Exchange Catheter and Laryngeal Mask Airway in people with Intubation, Endotracheal, 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 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 23 Mar 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and arytenoids. 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 23 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.