NCT01346384

Brief Summary

The purpose of this study is to investigate the time-related intracuff pressure and volume change (which reflects the pharyngeal pressure) of the LT during anesthesia with N2O.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2011

Completed
Last Updated

May 5, 2011

Status Verified

April 1, 2011

Enrollment Period

1.6 years

First QC Date

April 25, 2011

Last Update Submit

May 3, 2011

Conditions

Adult Disease

Keywords

intracuff pressurelaryngeal tubenitrous oxide

Outcome Measures

Primary Outcomes (1)

  • intracuff pressure

    measured intracuff pressure of LT with N2O during intraoperative period

    1-4 hours

Study Arms (1)

intracuff pressure N2O

measured intracuff pressure of LT with N2o during operative period

Device: laryngeal tube (VBM Medizintechnik)

Interventions

laryngeal tube (VBM Medizintechnik)DEVICE

laryngeal tube number 4

Also known as: The laryngeal tube (VBM Medizintechnik, Sulz, Germany)
intracuff pressure N2O

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with general anesthesia

You may qualify if:

  • American Society of Anesthesiologist physical status I or II
  • Undergoing elective orthopedic surgery and surgery of breast under general anesthesia with an expected duration of 60 min or more

You may not qualify if:

  • Height was \< 155 or \>180 cm (for the use of laryngeal tube size 4)
  • Body mass index ≥35 kg/m2
  • Preexisting laryngotracheal disease
  • Risk of pulmonary aspiration of gastric contents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2011

First Posted

May 3, 2011

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 5, 2011

Record last verified: 2011-04

Locations

TH(1)