## Protocol Section
### Identification Module
**NCT ID:** NCT03033979

**Brief Title:** Prolonged Laryngeal Mask Airway ProSealTM Use

**Official Title:** Prolonged Use of the Laryngeal Mask Airway ProSealTM: a Report of Seven Cases Lasting 5-11 Hours

#### Organization Study ID Info
**ID:** Schulthess_Anä_9
#### Organization
**Class:** OTHER
**Full Name:** Schulthess Klinik
### Status Module
#### Completion Date
**Date:** 2015-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01-01

**Type:** ACTUAL

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2017-01-27
**Type:** ESTIMATED
**Study First Submit Date:** 2017-01-25
**Study First Submit QC Date:** 2017-01-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Schulthess Klinik

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The investigators conclude that use of the LMA ProSealTM for prolonged procedures is feasible. In principle, it should be safer and more effective than the LMA ClassicTM provided basic guidelines are followed.

**Detailed Description:** There is controversy concerning use of the classic laryngeal mask airway (LMA ClassicTM) for prolonged procedures, particularly over 2 hours, as some clinicians consider it unsuitable for positive pressure ventilation (needed to counter the alleged progressive respiratory fatigue with time) and/or unsuitable for airway protection (needed to counter the alleged progressive increase in aspiration risk with time). The LMA ProSealTM is a laryngeal mask device with a modified cuff to facilitate ventilation and a drain tube to provide airway protection. In principle, the LMA ProSealTM should be more suitable than the LMA ClassicTM for prolonged procedures; however, there are only four reports and one case series.

### Conditions Module

**Conditions:**

- Airway Management

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Oropharyngeal leak pressure

**Measure:** Feasibility of the LMA ProSealTM for prolonged use

**Time Frame:** 30 Minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* ASA 1 - 3
* Age 19-85 yr
* Written informed consent

Exclusion Criteria:

* Difficult airway
* Non fasted
* BMI \> 35

**Maximum Age:** 85 Years

**Minimum Age:** 19 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** We describe the use of the LMA ProSealTM in seven patients in a variety of clinical situations for procedures lasting more than 5 hours.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zürich

**Country:** Switzerland

**Facility:** Christian Keller MD, M.Sc.

**Zip:** 8008

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
