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Clinical Comparison of the Airway Devices

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00581386
Enrollment
218
Registered
2007-12-27
Start date
2007-05-31
Completion date
2009-04-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation, Supraglottic Airway

Keywords

Endotracheal Intubation, Supraglottic Airway

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.

Interventions

DEVICELTS-D

supra-glottic airway device

pre-existing double-lumen supra-glottic device

DEVICEEsophageal Tracheal Combitube (ETC)

disposable double-lumen tube

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Leak PressuresDuration of surgeryThe maximum leak pressure attained for each device.
Duration of Intubationduration of intubationThe time taken to successfully place the device in seconds.
Number of Participants With a Successful First Attempt PlacementTime taken for successful placementThe 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 taken for intubationThe 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.
Post Operative Morbidity2 hrs and 24 hrs after surgeryWe 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 CasesTime taken for successful intubationWe 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.

Countries

United States

Participant flow

Recruitment details

Patients were recruited from the Memorial Hermann Hospital between 05/30/2007 and 04/15/2009. The patients enrolled were undergoing general anesthesia.

Pre-assignment details

There were no enrolled participants excluded from trial before assignment to groups.

Participants by arm

ArmCount
Disposable Laryngeal Tube Suction (LTS-D)
Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
73
Esophageal Tracheal Combitube(ETC)
Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
73
ProSeal Laryngeal Mask Airway (PLMA)
Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
72
Total218

Baseline characteristics

CharacteristicTotalDisposable Laryngeal Tube Suction (LTS-D)Esophageal Tracheal Combitube(ETC)ProSeal Laryngeal Mask Airway (PLMA)
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
218 Participants73 Participants73 Participants72 Participants
Age, Continuous40.47 years
STANDARD_DEVIATION 14.12
41.84 years
STANDARD_DEVIATION 14.95
39.45 years
STANDARD_DEVIATION 13.73
40.08 years
STANDARD_DEVIATION 13.68
Region of Enrollment
United States
218 participants73 participants73 participants72 participants
Sex: Female, Male
Female
63 Participants23 Participants23 Participants17 Participants
Sex: Female, Male
Male
155 Participants50 Participants50 Participants55 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 730 / 730 / 72
serious
Total, serious adverse events
0 / 730 / 730 / 72

Outcome results

Primary

Duration of Intubation

The time taken to successfully place the device in seconds.

Time frame: duration of intubation

ArmMeasureValue (MEAN)Dispersion
Disposable Laryngeal Tube Suction (LTS-D)Duration of Intubation30.9 secondsStandard Deviation 18.7
Esophageal Tracheal Combitube(ETC)Duration of Intubation30.8 secondsStandard Deviation 23.3
ProSeal Laryngeal Mask Airway (PLMA)Duration of Intubation30.17 secondsStandard Deviation 31.53
Primary

Leak Pressures

The maximum leak pressure attained for each device.

Time frame: Duration of surgery

ArmMeasureValue (MEAN)Dispersion
Disposable Laryngeal Tube Suction (LTS-D)Leak Pressures25.9 cm of H2OStandard Deviation 4.6
Esophageal Tracheal Combitube(ETC)Leak Pressures23.5 cm of H2OStandard Deviation 5.3
ProSeal Laryngeal Mask Airway (PLMA)Leak Pressures24.4 cm of H2OStandard Deviation 5.09
p-value: 0.006t-test, 2 sided
Primary

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.

Time frame: Time taken for successful intubation

Population: As per protocol, a case is decided as a failed case when the patient was not able to be intubated with the assigned device after 3 attempts.

ArmMeasureValue (NUMBER)
Disposable Laryngeal Tube Suction (LTS-D)Number of Failed Cases4 Participants
Esophageal Tracheal Combitube(ETC)Number of Failed Cases9 Participants
ProSeal Laryngeal Mask Airway (PLMA)Number of Failed Cases5 Participants
Primary

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.

Time frame: Time taken for successful placement

Population: As per protocol,of all the patients intubated with the assigned specific device number of patients in whom the device was placed successfully in the first attempt.

ArmMeasureValue (NUMBER)
Disposable Laryngeal Tube Suction (LTS-D)Number of Participants With a Successful First Attempt Placement65 Participants
Esophageal Tracheal Combitube(ETC)Number of Participants With a Successful First Attempt Placement49 Participants
ProSeal Laryngeal Mask Airway (PLMA)Number of Participants With a Successful First Attempt Placement52 Participants
Primary

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.

Time frame: Time taken for intubation

Population: As per protocol,the number of cases in whom the device could not be placed successfully in first attempt and required 2nd and 3rd attempts.

ArmMeasureValue (NUMBER)
Disposable Laryngeal Tube Suction (LTS-D)Number of Patients Who Required Multiple Attempts.8 Participants
Esophageal Tracheal Combitube(ETC)Number of Patients Who Required Multiple Attempts.24 Participants
ProSeal Laryngeal Mask Airway (PLMA)Number of Patients Who Required Multiple Attempts.20 Participants
p-value: 0.01395% CI: [1.27, 7.67]Regression, Logistic
p-value: 0.00395% CI: [1.57, 9.29]Odds ratio
Primary

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.

Time frame: 2 hrs and 24 hrs after surgery

Population: As per protocol,all the patients were followed up at 2 hrs and 24hrs to check for any postoperative hoarseness, sorethroat and difficulty swallowing. The numbers represent the number of patients who complained of postoperative morbidity.

ArmMeasureValue (NUMBER)
Disposable Laryngeal Tube Suction (LTS-D)Post Operative Morbidity10 participants
Esophageal Tracheal Combitube(ETC)Post Operative Morbidity39 participants
ProSeal Laryngeal Mask Airway (PLMA)Post Operative Morbidity5 participants
p-value: 0.00395% CI: [1.728, 14.99]Regression, Logistic
p-value: 0.000495% CI: [2.419, 21.527]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026