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| Name | Class |
|---|---|
| Hospital Italiano de Buenos Aires | OTHER |
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The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.
Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD.
To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supreme Laryngeal Mask Airway | Active Comparator | Supreme Laryngeal Mask Airway |
|
| Laryngeal Tube Suction Disposable | Active Comparator | Laryngeal Tube Suction Disposable |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supreme Laryngeal Mask Airway | Device | Supreme Laryngeal Mask Airway |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary outcome oropharyngeal seal pressures, in cm H2O | Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of the 3 liters minute. The airway pressure at which an equilibrium was reached was noted( maximun allowed 40 cm H2O) | 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| Fiberoptic position | Scoring system of the fiberoptic view: ranged from grade 4 (full view of arytenoids and glottis), 3 (arytenoids and glottis partly visible), 2 (view of arytenoids, glottis or epiglottis), and 1 (no part of larynx identifiable). | 5 min |
| Measure | Description | Time Frame |
|---|---|---|
| Sore throat | Sore throat was assessed subjetively by the patient using the 0-10 Numeric Pain Rating Scale | 30 minutes after admission in Post Anesthetic Operative Unit ( PACU) and 24 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis A Gaitini, M.D. | Bnai Zion Medical Center and Hospital Italiano de Buenos Aires | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27716165 | Derived | Somri M, Vaida S, Garcia Fornari G, Mendoza GR, Charco-Mora P, Hawash N, Matter I, Swaid F, Gaitini L. A randomized prospective controlled trial comparing the laryngeal tube suction disposable and the supreme laryngeal mask airway: the influence of head and neck position on oropharyngeal seal pressure. BMC Anesthesiol. 2016 Oct 6;16(1):87. doi: 10.1186/s12871-016-0237-7. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 14, 2016 | |
| Unrelease | Yes | |
| Release | Aug 15, 2016 | |
| Reset | Oct 5, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2016 | Yes | |||
| Aug 15, 2016 |
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| Laryngeal Tube Suction Disposable | Device | Laryngeal Tube Suction Disposable |
|
| Oct 5, 2016 |