Laryngeal Masks for Bariatric Surgery

Phase 3

• Conditions: Morbid Obesity
• Interventions: Device: ProSeal; Device: Supreme LMA

• Registration Number: NCT01724970
• Lead Sponsor: University of Padova

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-09-14
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-07
• Last Update Submitted: 2012-11-07
• Study First Posted: 2012-11-12
• Last Update Posted: 2012-11-12
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLMA	ProSeal	ProSeal
SLMA	Supreme LMA	Supreme LMA

Primary Outcome Measures

Name	Time	Method
oropharyngeal leak pressure	intraoperatively, up to 3 hours

Secondary Outcome Measures

Name	Time	Method
satisfaction of the surgeon (ad hoc questionnaire)	day 1
total dosage of analgesic and antihemetic drugs	intra and postoperatively up to 24 hours
total anesthetic and analgesic drug dosages	intraoperatively and postoperatively, up to 24 hours from end of surgery
satisfaction of the patient (Iowa Satisfaction with Anesthesia Scale)	day 1
time to post-anesthetic discharge scoring system (PADSS) > 8	in PACU up 72 hours
EKG monitoring	postoperatively up to 72 hours
gastric distension	intraoperatively up to 3 hours
levels of pain and nausea (Visual Analogue Scale)	postoperatively up to 24 hours
pulse oximetry saturation	intraoperatively and postoperatively, up to 24 hours from end of surgery
metilen's blue	before end of surgery up to 3 hours

Trial Locations

Locations (1)

University of Padua; 🇮🇹 Padua, PD, Italy