Intubation Clinical Trial
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).
Status | Completed |
Enrollment | 218 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Hermann Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of Intubation | The time taken to successfully place the device in seconds. | duration of intubation | No |
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 taken for successful placement | No |
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 taken for intubation | No |
Primary | Leak Pressures | The maximum leak pressure attained for each device. | Duration of surgery | No |
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. | 2 hrs and 24 hrs after surgery | No |
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 taken for successful intubation | No |
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