N/A
Completed N=218
Clinical Comparison of the Airway Devices
Endotracheal Intubation · Supraglottic Airway
Source: ClinicalTrials.gov NCT00581386 ↗
Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Duration of Intubation — 30.9; 30.8; 30.17 seconds
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Intubation |
30.9; 30.8; 30.17 | — |
| PRIMARY Number of Participants With a Successful First Attempt Placement |
65; 49; 52 | — |
| PRIMARY Number of Patients Who Required Multiple Attempts. |
8; 24; 20 | 0.013 sig |
| PRIMARY Leak Pressures |
25.9; 23.5; 24.4 | 0.006 sig |
| PRIMARY Post Operative Morbidity |
10; 39; 5 | 0.003 sig |
| PRIMARY Number of Failed Cases |
4; 9; 5 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
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:
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT00581386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.