NCT00778219

Brief Summary

60 patients, in three group of 20 patients each, scheduled for surgery needing general anesthesia will be researched. Group A: tracheal intubation of single lumen tube using laryngoscope. Group B: single lumen tube using lightwand. Group C: double lumen endobronchial cath. During general anesthesia, the spectral power of heart rate variability at three periods: (1) preoperation baseline (2) pre-intubation and (3) post-intubation will be calculated and compared to investigate the autonomic stimulation effect of different tracheal intubation methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

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

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

October 22, 2008

Last Update Submit

December 14, 2009

Conditions

Keywords

heart rate variability, tracheal intubation

Outcome Measures

Primary Outcomes (1)

  • spectral power of heart rate variability

    5 minutes

Study Arms (3)

A

Patients needing intubation of single lumen tracheal tube and performed using laryngoscope

Device: devices for tracheal intubation

B

Patients needing intubation of single lumen tracheal tube and performed using lightwand

Device: devices for tracheal intubation

C

Patients needing intubation of double lumen endobronchial cath and performed using laryngoscope

Device: devices for tracheal intubation

Interventions

tracheal intubation by laryngoscope or lightwand

ABC

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

60 ASA class I-II patients , age 18-65, scheduled for surgery and need general anesthesia with tracheal intubation

You may qualify if:

  • ASA class I-II, age 18-65, scheduled for surgery needing general anesthesia with tracheal intubation

You may not qualify if:

  • history of major systemic diseases such as cardiovascular, pulmonary, renal and other diseases which affect autonomic activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Interventions

Equipment and SuppliesIntubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Hui-Hsun Huang, MD, PhD

    Department of anesthesiology, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations