NCT00972491

Brief Summary

Laryngeal mask airway (LMA) is routinely used for some patients who have surgery under general anesthesia. LMA is placed in the mouth and allow the anesthesia to be given without having to put a breathing tube in the throat. Previous studies have focused on the effect of different anesthesia medicines on optimal condition for LMA use. The objective of the present study is to find the optimal time for LMA insertion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 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

Study Start

First participant enrolled

September 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

4.3 years

First QC Date

September 3, 2009

Last Update Submit

December 3, 2013

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Ease of Mouth opening

    From Induction of general anesthesia to satisfactory LMA insertion

Study Arms (1)

0 sec, 60 sec, 90 sec

OTHER

LMA will be inserted at 0, 60, and 90 seconds after eyelash reflex disappears

Procedure: Insertion of Laryngeal Mask Airway

Interventions

Insertion of Laryngeal Mask AirwayPROCEDURE

The LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia

Also known as: Laryngeal Mask Airway
0 sec, 60 sec, 90 sec

Eligibility Criteria

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

You may qualify if:

  • subjects 18 years or older
  • ASA status 1-3

You may not qualify if:

  • high risk of aspiration
  • anticipated difficult airway
  • use of sedative drugs
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, IntratrachealAirway ManagementTherapeuticsIntubationInvestigative TechniquesMasksProtective DevicesEquipment and SuppliesPersonal Protective EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Pei-shan Zhao, MD,PhD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2009

First Posted

September 7, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)