Endotracheal IntubationNCT00581386
Clinical Comparison of the Airway Devices
A study testing LTS-D, ProSeal Laryngeal Mask Airway and Esophageal Tracheal Combitube (ETC) in people with Endotracheal Intubation and 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 evaluate a new supra-glottic airway device, the "Disposable Laryngeal Tube Suction" (LTS-D; King Systems, Noblesville, IN). We propose to test its ease of insertion, position within the airway, patency of drain tube and anatomic sealing properties during spontaneous ventilation in… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Endotracheal Intubation, Supraglottic Airway
- What is being tested?
- LTS-D, ProSeal Laryngeal Mask Airway and Esophageal Tracheal Combitube (ETC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2009
- 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
- The subjects will be adult surgical candidates aged 18-80, ASA I-III, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
- Both male and female patients will be included.
Who cannot join
- Patients will be excluded from the study if they present as Mallampati III or IV, ASA IV-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA ProSeal including:
- Obesity
- Pregnancy
- History of gastric regurgitation, heart burn, ileus or "full stomach"
- History of low pulmonary compliance or high pulmonary resistance
- Known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
Show all 16Show fewer
- Pharyngeal pathology or
- Upper airway obstruction due to laryngeal pathology.
- Additionally, they will be excluded if they meet one of the contraindication criteria for the Combitube including:
- Intact gag reflexes
- Height <4 feet
- Central airway obstruction
- Recent ingestion of caustic substances
- Known esophageal pathology, or
- Known latex allergy.
- They will also be excluded if any tracheal disease is present such as tracheal tumors, stenosis or previous tracheal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Comparison Of The King Systems Disposable Laryngeal Tube Suction (LTS-D), The Esophageal Tracheal Combitube (ETC) And The Proseal Laryngeal Mask Airway (PLMA) In Adult Patients
The purpose of this study is to evaluate a new supra-glottic airway device, the "Disposable Laryngeal Tube Suction" (LTS-D; King Systems, Noblesville, IN). We propose to test its ease of insertion, position within the airway, patency of drain tube and anatomic sealing properties during spontaneous ventilation in anesthetized patients. The study device will be compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).
Read the detailed description
During the past decade, several pharyngeal airways have been introduced into clinical practice for airway management, such as the Laryngeal Mask Airway (LMA), the Cuffed Oropharyngeal Airway (COPA), the Esophageal Tracheal Combitube (ETC), and most recently, the Laryngeal Tube (LT). These airway devices have become very popular because of their ability to maintain an airway without perturbing the trachea, and can be used in patients without muscle relaxation and who are only lightly anesthetized.
The LMA generally provides an adequate airway, but certain problems remain. (1) In 8-33% of LMA placements, more than one attempt is required. (2) It is sometimes difficult to advance the LMA without extending the neck (which is contraindicated in some patients). (3) The device does not protect the airway from aspiration of gastric contents. (4) It does not provide an airtight seal around the larynx (the usual pressures causing leakage of gas being 15-20 cm H20). Consequently, the device functions poorly during positive-pressure ventilation. (5) The esophagus is included within the rim of the LMA in 10-15% of patients, directly exposing the esophagus to positive airway pressures. This often results in insufflation of the stomach and postoperative discomfort.
The ETC is a disposable double-lumen tube that combines the features of a conventional endotracheal tube with those of an esophageal obturator airway. It is appropriate for prehospital, intraoperative, and emergency use and is especially useful for patients in whom direct visualization of the vocal cords is not possible, patients with massive airway bleeding or regurgitation, limited access to the airway, and patients in whom neck movement is contraindicated. Ventilation with the ETC is possible with either tracheal or esophageal intubation, as its distal cuff seals off the esophagus to prevent aspiration of gastric contents. The ETC has a 6.9% incidence of placement failure and a failed ventilation rate of 21.1%.
The Laryngeal Tube Suction (LTS; VBM Medizintechnik; King Systems, Noblesville, IN) is a supra-glottic airway device designed to provide a more effective seal than the LMA, thus eliminating problems 3-5 described above. The insertion of the standard laryngeal tube is generally easy. The reported success rate of insertion of, and ventilation through, the laryngeal tube ranges from 92-100% for the earlier prototype and 97-100% for the newest version. It is a flexible, curved tube that passes through the mouth, advances posterior to the epiglottis, and terminates in the upper esophagus. The multi-use, double-lumen, silicon LTS is designed with ventilation outlets located between an oropharyngeal and an esophageal, low-pressure cuff. The second lumen allows for an orogastric tube to be passed through for gastric drainage and pressure release. Patients at risk of regurgitation now have an alternative to tracheal intubation. This device has been used in a number of patients by anesthesiologists in Europe. There are many published scientific abstracts in the use of the LTS. A disposable version of the LTS is now available, the LTS-D. The LTS-D offers the same benefits as the LTS, but being disposable, it also eliminates the risk of cross-infection.
The ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) is the pre-existing double-lumen supra-glottic device that allows gastric drainage and pressure release. Its design is based on the LMA with an added lumen. It is reusable. The ProSeal exhibits an unsuccessful ventilation rate of 9%, and a first time insertion failure of 12.7%. Currently, the ProSeal exhibits a 3% incidence of foldover during insertion that prevents it from functioning properly. Due to differences in design, we postulate that the LTS-D will have a lower incidence of foldover than the PLMA.
This clinical study has been designed to compare the ProSeal, ETC and LTS-D as to the ease of placement and ventilation during controlled ventilation, proper positioning, the seal pressure with each placement, the patency of the drain tube by suctioning and measuring stomach contents, and finally, any complications with their use. Fiberoptic observations through each device will provide information in relation to the epiglottis and the distal opening of the device.
- Conditions
- Endotracheal Intubation, Supraglottic Airway
- Being tested
- LTS-D, ProSeal Laryngeal Mask Airway, Esophageal Tracheal Combitube (ETC)
- Keywords
- Endotracheal Intubation, Supraglottic Airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTS-DDevice
Also called LTS-D King Systems, Noblesville, IN
supra-glottic airway device
ProSeal Laryngeal Mask AirwayDevice
Also called Laryngeal Mask Airway (PLMA, LMA North America Inc.)
pre-existing double-lumen supra-glottic device
Esophageal Tracheal Combitube (ETC)Device
Also called ETC
disposable double-lumen tube
| Study group | Role | What they receive |
|---|---|---|
| LTS-D | Experimental | All the cases were divided into one of the group LTS-D, PLMA, and ETC Receives: Device: LTS-D |
| ProSeal Laryngeal Mask Airway | Experimental | All patients were divided into either LTS-D, PLMA, or the ETC group. Receives: Device: ProSeal Laryngeal Mask Airway |
| Esophageal Tracheal Combitube (ETC) | Experimental | All patients are divided into one of the group, LTS-D, PLMA, or the ETC. Receives: Device: Esophageal Tracheal Combitube (ETC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Intubation
The time taken to successfully place the device in seconds.
Measured: duration of intubation
Number of Participants With a Successful First Attempt Placement
The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.
Measured: Time taken for successful placement
Number of Patients Who Required Multiple Attempts.
The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.
Measured: Time taken for intubation
Leak Pressures
The maximum leak pressure attained for each device.
Measured: Duration of surgery
Post Operative Morbidity
We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.
Measured: 2 hrs and 24 hrs after surgery
Number of Failed Cases
We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.
Measured: Time taken for successful intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2009
- Study completionApr 2009
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 Endotracheal IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- NCT00581386
- Sponsor's protocol ID
- HSC-MS-04-254
- Status last verified
- Aug 2016
- First submitted
- 20 Dec 2007
- Last updated
- 20 Sep 2016
- 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 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Comparison Of The King Systems Disposable Laryngeal Tube Suction (LTS-D), The Esophageal Tracheal Combitube (ETC) And The Proseal Laryngeal Mask Airway (PLMA) In Adult Patients
- ClinicalTrials.gov ID
- NCT00581386
- Acronym / sponsor ID
- HSC-MS-04-254
- Conditions
- Endotracheal Intubation, Supraglottic Airway
- Keywords
- Endotracheal Intubation, Supraglottic Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 4 Mar 2010
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 evaluate a new supra-glottic airway device, the "Disposable Laryngeal Tube Suction" (LTS-D; King Systems, Noblesville, IN). We propose to test its ease of insertion, position within the airway, patency of drain tube and anatomic sealing properties during spontaneous ventilation in anesthetized patients. The study device will be compared to the ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) and the Esophageal Tracheal Combitube (ETC; Tyco Healthcare/Mallinckrodt Nellcor, Pleasanton, Calif).
Detailed description
During the past decade, several pharyngeal airways have been introduced into clinical practice for airway management, such as the Laryngeal Mask Airway (LMA), the Cuffed Oropharyngeal Airway (COPA), the Esophageal Tracheal Combitube (ETC), and most recently, the Laryngeal Tube (LT). These airway devices have become very popular because of their ability to maintain an airway without perturbing the trachea, and can be used in patients without muscle relaxation and who are only lightly anesthetized.
The LMA generally provides an adequate airway, but certain problems remain. (1) In 8-33% of LMA placements, more than one attempt is required. (2) It is sometimes difficult to advance the LMA without extending the neck (which is contraindicated in some patients). (3) The device does not protect the airway from aspiration of gastric contents. (4) It does not provide an airtight seal around the larynx (the usual pressures causing leakage of gas being 15-20 cm H20). Consequently, the device functions poorly during positive-pressure ventilation. (5) The esophagus is included within the rim of the LMA in 10-15% of patients, directly exposing the esophagus to positive airway pressures. This often results in insufflation of the stomach and postoperative discomfort.
The ETC is a disposable double-lumen tube that combines the features of a conventional endotracheal tube with those of an esophageal obturator airway. It is appropriate for prehospital, intraoperative, and emergency use and is especially useful for patients in whom direct visualization of the vocal cords is not possible, patients with massive airway bleeding or regurgitation, limited access to the airway, and patients in whom neck movement is contraindicated. Ventilation with the ETC is possible with either tracheal or esophageal intubation, as its distal cuff seals off the esophagus to prevent aspiration of gastric contents. The ETC has a 6.9% incidence of placement failure and a failed ventilation rate of 21.1%.
The Laryngeal Tube Suction (LTS; VBM Medizintechnik; King Systems, Noblesville, IN) is a supra-glottic airway device designed to provide a more effective seal than the LMA, thus eliminating problems 3-5 described above. The insertion of the standard laryngeal tube is generally easy. The reported success rate of insertion of, and ventilation through, the laryngeal tube ranges from 92-100% for the earlier prototype and 97-100% for the newest version. It is a flexible, curved tube that passes through the mouth, advances posterior to the epiglottis, and terminates in the upper esophagus. The multi-use, double-lumen, silicon LTS is designed with ventilation outlets located between an oropharyngeal and an esophageal, low-pressure cuff. The second lumen allows for an orogastric tube to be passed through for gastric drainage and pressure release. Patients at risk of regurgitation now have an alternative to tracheal intubation. This device has been used in a number of patients by anesthesiologists in Europe. There are many published scientific abstracts in the use of the LTS. A disposable version of the LTS is now available, the LTS-D. The LTS-D offers the same benefits as the LTS, but being disposable, it also eliminates the risk of cross-infection.
The ProSeal Laryngeal Mask Airway (PLMA, LMA North America Inc.) is the pre-existing double-lumen supra-glottic device that allows gastric drainage and pressure release. Its design is based on the LMA with an added lumen. It is reusable. The ProSeal exhibits an unsuccessful ventilation rate of 9%, and a first time insertion failure of 12.7%. Currently, the ProSeal exhibits a 3% incidence of foldover during insertion that prevents it from functioning properly. Due to differences in design, we postulate that the LTS-D will have a lower incidence of foldover than the PLMA.
This clinical study has been designed to compare the ProSeal, ETC and LTS-D as to the ease of placement and ventilation during controlled ventilation, proper positioning, the seal pressure with each placement, the patency of the drain tube by suctioning and measuring stomach contents, and finally, any complications with their use. Fiberoptic observations through each device will provide information in relation to the epiglottis and the distal opening of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LTS-D | Experimental | Device: LTS-DAll the cases were divided into one of the group LTS-D, PLMA, and ETC |
| ProSeal Laryngeal Mask Airway | Experimental | Device: ProSeal Laryngeal Mask AirwayAll patients were divided into either LTS-D, PLMA, or the ETC group. |
| Esophageal Tracheal Combitube (ETC) | Experimental | Device: Esophageal Tracheal Combitube (ETC)All patients are divided into one of the group, LTS-D, PLMA, or the ETC. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subjects will be adult surgical candidates aged 18-80, ASA I-III, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
- Both male and female patients will be included.
Key exclusion criteria (16 listed)
- Patients will be excluded from the study if they present as Mallampati III or IV, ASA IV-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA ProSeal including:
- Additionally, they will be excluded if they meet one of the contraindication criteria for the Combitube including:
- They will also be excluded if any tracheal disease is present such as tracheal tumors, stenosis or previous tracheal 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 |
|---|---|---|
| LTS-DAlso: LTS-D King Systems, Noblesville, INsupra-glottic airway device | Device | LTS-D |
| ProSeal Laryngeal Mask AirwayAlso: Laryngeal Mask Airway (PLMA, LMA North America Inc.)pre-existing double-lumen supra-glottic device | Device | ProSeal Laryngeal Mask Airway |
| Esophageal Tracheal Combitube (ETC)Also: ETCdisposable double-lumen tube | Device | Esophageal Tracheal Combitube (ETC) |
Primary outcome
Duration of Intubation
Time frame: duration of intubation
The time taken to successfully place the device in seconds.
Number of Participants With a Successful First Attempt Placement
Time frame: Time taken for successful placement
The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.
Number of Patients Who Required Multiple Attempts.
Time frame: Time taken for intubation
The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.
Leak Pressures
Time frame: Duration of surgery
The maximum leak pressure attained for each device.
Post Operative Morbidity
Time frame: 2 hrs and 24 hrs after surgery
We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.
Number of Failed Cases
Time frame: Time taken for successful intubation
We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- 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, 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 study testing LTS-D, ProSeal Laryngeal Mask Airway and Esophageal Tracheal Combitube (ETC) in people with Endotracheal Intubation and 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 2 inclusion and 16 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 20 Sep 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2010). 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?
Duration of Intubation (time frame: duration of intubation). The study lists 6 primary outcomes in all. 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 20 Sep 2016.