Comparison of Heart Rate Variability Among Tracheal Intubation Methods - Full Text View

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00778219

Purpose

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.

Condition	Intervention
Intubation, Endotracheal	Device: devices for tracheal intubation

MedlinePlus related topics: Anesthesia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Comparison of Autonomic Stimulation Among Different Tracheal Intubation Methods -- Using Non-Invasive Heart Rate Variability Spectral Power as an Indicator

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

spectral power of heart rate variability [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Patients needing intubation of single lumen tracheal tube and performed using laryngoscope	Device: devices for tracheal intubation tracheal intubation by laryngoscope or lightwand
B Patients needing intubation of single lumen tracheal tube and performed using lightwand	Device: devices for tracheal intubation tracheal intubation by laryngoscope or lightwand
C Patients needing intubation of double lumen endobronchial cath and performed using laryngoscope	Device: devices for tracheal intubation tracheal intubation by laryngoscope or lightwand

Detailed Description:

Tracheal intubation is a common practice during general anesthesia. Laryngoscope and lightwand are two commonly used methods of tracheal intubation. The autonomic stimulation of tracheal intubation may have adverse effect to the patients and have been investigated since many years ago. Conventional methods for assessing autonomic activity include measurement of blood catecholamine levels or measuring changes of the hemodynamic variables such as heart rate and blood pressure. The former is invasive and noncontinuous, and the latter is nonspecific and not accurate. Heart rate variability, a parameter derived from the spectral power of RR interval sequence in the ECG, is a non-invasive but direct measurement of autonomic activity. It is ideal and we will use this in the current research for comparing the autonomic activation during tracheal intubation of the two different methods.

Totally 60 ASA class I-II patients aged 18-65 years will be recruited. 40 of these are scheduled for various kind of surgery needing general anesthesia with tracheal intubation of single lumen tube. These 40 patients will be randomly assigned into group A and B, each with 20 patients. In group A the tracheal intubation will be performed by laryngoscope, and in group B the intubation performed by lightwand. The other 20 patients of the study, the group C, are scheduled for operations needing intubation of double lumen endobronchial cath. The intubation will be performed by laryngoscope.

ECG wil be recorded from at least 5 minutes before induction of general anesthesia and continue to at least 10 minutes after tracheal intubation. The induction and maintenance of anesthesia will performed as routine practice. The ECG records wil be analyzed offline. Power spectrum wil be generated by time-frequency analysis and the heart rate variability parameters at three periods (1)preoperation baseline (2) pre-intubation and (3) immediately post-intubation will be calculated and compared among the three groups.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778219

Contacts

Contact: Hui-Hsun Huang, MD, PhD

886-2-23123456 ext 65515

hhh@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Hui-Hsun Huang, MD, PhD 886-2-23123456 ext 65515 hhh@ntu.edu.tw
Principal Investigator: Hui-Hsun Huang, MD, PhD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Hui-Hsun Huang, MD, PhD

Department of anesthesiology, National Taiwan University Hospital

More Information

Responsible Party:	National Taiwan University Hospital, department of anesthesiology ( Hui-Hsun Huang, visiting staff )
Study ID Numbers:	200808060R
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778219
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

heart rate variability, tracheal intubation

ClinicalTrials.gov processed this record on January 14, 2009