Clinical trial NCT00581386: Clinical Comparison of the Airway Devices
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Supraglottic Airway
Keywords: Endotracheal Intubation
Supraglottic Airway
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Both male and female patients will be included.

Exclusion Criteria:

* 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:

  1. Obesity
  2. Pregnancy
  3. History of gastric regurgitation, heart burn, ileus or "full stomach"
  4. History of low pulmonary compliance or high pulmonary resistance
  5. Known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
  6. Pharyngeal pathology or
  7. Upper airway obstruction due to laryngeal pathology.
* Additionally, they will be excluded if they meet one of the contraindication criteria for the Combitube including:

  1. Intact gag reflexes
  2. Height \<4 feet
  3. Central airway obstruction
  4. Recent ingestion of caustic substances
  5. Known esophageal pathology, or
  6. Known latex allergy.
* They will also be excluded if any tracheal disease is present such as tracheal tumors, stenosis or previous tracheal surgery.

Primary outcomes:
measure: Duration of Intubation
timeFrame: duration of intubation
measure: Number of Participants With a Successful First Attempt Placement
timeFrame: Time taken for successful placement
measure: Number of Patients Who Required Multiple Attempts.
timeFrame: Time taken for intubation
measure: Leak Pressures
timeFrame: Duration of surgery
measure: Post Operative Morbidity
timeFrame: 2 hrs and 24 hrs after surgery
measure: Number of Failed Cases
timeFrame: Time taken for successful intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Medical School at Houston
name: Carin A. Hagberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: