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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Memorial Hermann Hospital

    Houston, Texas, 77030

Other trials in United States

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.

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 groups in NCT00581386
Study groupRoleWhat they receive
LTS-DExperimentalAll the cases were divided into one of the group LTS-D, PLMA, and ETC
Receives: Device: LTS-D
ProSeal Laryngeal Mask AirwayExperimentalAll patients were divided into either LTS-D, PLMA, or the ETC group.
Receives: Device: ProSeal Laryngeal Mask Airway
Esophageal Tracheal Combitube (ETC)ExperimentalAll 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.

  1. Duration of Intubation

    The time taken to successfully place the device in seconds.

    Measured: duration of intubation

  2. 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

  3. 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

  4. Leak Pressures

    The maximum leak pressure attained for each device.

    Measured: Duration of surgery

  5. 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

  6. 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.

  1. First posted27 Dec 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

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)
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
Data monitoring committee
No
Individual data sharing
Undecided

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.

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