NCT00402870

Brief Summary

The ProSeal laryngeal mask airway is a relatively new airway device with a modified cuff to increase the seal and a drain tube to provide a channel for regurgitated fluid, prevention of gastric insufflation and insertion of a gastric tube. In the following randomized prospective double-blind trial, we test the hypothesis that the postoperative analgesic requirements is higher for the ProSeal laryngeal mask airway than the tracheal tube.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 20, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

December 4, 2007

Status Verified

December 1, 2007

First QC Date

November 20, 2006

Last Update Submit

December 3, 2007

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    24 hrs

Interventions

ProSeal LMADEVICE

ProSeal LMA vs Tracheal Tube

ProSeal LMA, Tracheal TubeDEVICE

ProSeal LMA vs Tracheal Tube

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • ASA I-II
  • Age 18-75
  • Elective laparoscopic surgery

You may not qualify if:

  • Known or predicted difficult airway
  • Oropharyngeal pathology
  • Mouth opening \< 3.0 cm
  • A body mass index \> 35 kg m-2
  • Increased risk of aspiration
  • Inability to communicate or understand the visual analogue scale
  • Analgesics within 24 hours of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesia

Innsbruck, Innsbruck, 6020, Austria

Location

Study Officials

  • Christian Keller, MD, M.Sc.

    Dept of Anesthesia, Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 20, 2006

First Posted

November 22, 2006

Study Start

August 1, 2007

Study Completion

September 1, 2007

Last Updated

December 4, 2007

Record last verified: 2007-12

Locations

AU(1)