Laryngeal Masks for Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

A Randomized Comparative Study on Proseal LMATM and Supreme LMATM for Bariatric Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01724970
• Other study ID #: 2276P
• Status: Recruiting
• Phase: Phase 3
• First received: September 14, 2012
• Last updated: November 7, 2012
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2012
• Source: University of Padova
• Contact: Michele Carron, MD
• Phone: +39 049 821 3090
• Email: michele.carron[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Obese people pose specific problems as far as the management of airway during surgery. The study aims to compare efficacy and safety of two LMA devices.

Description:

The study will investigate two types of LMA devices endowed of different constructive features. The two devices share common features as far as providing access to the stomach and reducing morbidity of the upper airway. The two device differ in regard to ease of insertion and sealing of the airway and these features are particularly important in the obese patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA class I-III

• candidates to bariatric surgery

Exclusion Criteria:

• uncontrolled psychiatric symptomatology

• known or presumed pregnancy

• history of surgery on the airway or esophagus

• gastroesophageal reflux

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• ProSeal
Patients will be ventilated with PLMA
• Supreme LMA
Patients will be ventilated with SLMA

Locations

Country	Name	City	State
Italy	University of Padua	Padua	PD

Sponsors (2)

Lead Sponsor	Collaborator
University of Padova	Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	insertion time		up to 10 minutes	Yes
Primary	oropharyngeal leak pressure		intraoperatively, up to 3 hours	Yes
Secondary	total anesthetic and analgesic drug dosages		intraoperatively and postoperatively, up to 24 hours from end of surgery	No
Secondary	pulse oximetry saturation		intraoperatively and postoperatively, up to 24 hours from end of surgery	Yes
Secondary	time to post-anesthetic discharge scoring system (PADSS) > 8		in PACU up 72 hours	Yes
Secondary	EKG monitoring		postoperatively up to 72 hours	Yes
Secondary	satisfaction of the surgeon (ad hoc questionnaire)		day 1	No
Secondary	satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)		day 1	No
Secondary	gastric distension		intraoperatively up to 3 hours	Yes
Secondary	levels of pain and nausea (Visual Analogue Scale)		postoperatively up to 24 hours	Yes
Secondary	metilen's blue		before end of surgery up to 3 hours	Yes
Secondary	total dosage of analgesic and antihemetic drugs		intra and postoperatively up to 24 hours	Yes