Comparison of Heart Rate Variability Among Tracheal Intubation Methods

Intubation, Endotracheal Clinical Trial

Official title:

Comparison of Autonomic Stimulation Among Different Tracheal Intubation Methods -- Using Non-invasive Heart Rate Variability Spectral Power as an Indicator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778219
• Other study ID #: 200808060R
• Status: Completed
• Phase: N/A
• First received: October 22, 2008
• Last updated: December 14, 2009
• Start date: October 2008
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intubation, Endotracheal

Intervention

Device:
• devices for tracheal intubation
tracheal intubation by laryngoscope or lightwand

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spectral power of heart rate variability		5 minutes	No