NCT01724970

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

2 years

First QC Date

September 14, 2012

Last Update Submit

November 7, 2012

Conditions

Morbid Obesity

Keywords

anesthesiapostanesthetic recoveryventilationbariatric surgery

Outcome Measures

Primary Outcomes (1)

  • oropharyngeal leak pressure

    intraoperatively, up to 3 hours

Secondary Outcomes (10)

  • total anesthetic and analgesic drug dosages

    intraoperatively and postoperatively, up to 24 hours from end of surgery

  • pulse oximetry saturation

    intraoperatively and postoperatively, up to 24 hours from end of surgery

  • time to post-anesthetic discharge scoring system (PADSS) > 8

    in PACU up 72 hours

  • EKG monitoring

    postoperatively up to 72 hours

  • satisfaction of the surgeon (ad hoc questionnaire)

    day 1

  • +5 more secondary outcomes

Other Outcomes (1)

  • insertion time

    up to 10 minutes

Study Arms (2)

PLMA

EXPERIMENTAL

ProSeal

Device: ProSeal

SLMA

EXPERIMENTAL

Supreme LMA

Device: Supreme LMA

Interventions

ProSealDEVICE

Patients will be ventilated with PLMA

PLMA
Supreme LMADEVICE

Patients will be ventilated with SLMA

SLMA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class I-III
  • candidates to bariatric surgery

You may not qualify if:

  • uncontrolled psychiatric symptomatology
  • known or presumed pregnancy
  • history of surgery on the airway or esophagus
  • gastroesophageal reflux

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Padua

Padua, PD, 35121, Italy

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidRespiratory Aspiration

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Officials

  • Michele Carron, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Carron, MD

CONTACT

+39 049 821 3090michele.carron@unipd.it

Ulderico Freo, MD

CONTACT

+39 049 821 3090ulderico.freo@unipd.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2012

First Posted

November 12, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

IT(1)