Heart Rate Variability for Prediction of Perioperative Events

Status Completed

Clinical Trial Summary

Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability. To investigate whether differences of HRV parameters predict perioperative cardiovascular events.

Clinical Trial Description

Hypotension and bradycardia following induction of anesthesia may result in insufficient organ perfusion. Patients with underlying cardiovascular disease are at high risk of perioperative cardiovascular events and death. Hemodynamic variables are controlled by the autonomic nervous system reflected by Heart Rate Variability (HRV). Several authors demonstrated depressed long-term HRV in patients with underlying cardiovascular disease. Depressed 24 hours HRV proved to be highly predictive for cardiovascular morbidity and mortality Recently, short-term analysis was demonstrated to be a reliable tool to predict hypotension after spinal anesthesia. No data are available, however, with respect to preoperative HRV values and incidence of postoperative cardiovascular events. To investigate the prognostic value of HRV in patients with underlying cardiovascular disease. Hypothesise i) differences in pre-operative HRV are present in patients with underlying cardiovascular disease, ii) depressed preoperative HRV indicates high risk of post-operative cardiac ischemia, iii) depressed preoperative HRV is associated with longer postoperative hospital stay and adverse cardiac events after hospital discharge.

First, patients are assigned to one of two groups depending on the presence or absence of postoperative cardiac ischemia; second, a predictive model will be built to confirm our findings prospectively in another group of patients.

Patients: 100 patients (ASA physical status class II - IV) scheduled for general anesthesia. Inclusion criteria:evidence of high perioperative cardiovascular risk based on the Revised Cardiac Risk Index (RCRI >3).Exclusion criteria: lack of sinus rhythm, emergency cases, postoperative admission to an intensive care unit and age under 18 years. Time and frequency domain parameters of HRV will be recorded at the day of surgery before induction of anesthesia. Cardiovascular events and outcome will be analyzed. ;

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00481234
Study type	Observational
Source	University of Schleswig-Holstein
Contact
Status	Completed
Phase	N/A
Start date	June 2002
Completion date	December 2006

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04580030` - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting	`NCT04279054` - Decreased Neuraxial Morphine After Cesarean Delivery	Early Phase 1
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Recruiting	`NCT04099693` - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated	`NCT02481999` - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed	`NCT04235894` - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting	`NCT05525104` - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).	N/A
Recruiting	`NCT05024084` - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth	Phase 4
Completed	`NCT04204785` - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions	N/A
Completed	`NCT03277872` - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope	N/A
Terminated	`NCT03940651` - Cardiac and Renal Biomarkers in Arthroplasty Surgery	Phase 4
Terminated	`NCT02529696` - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Terminated	`NCT03704285` - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting	`NCT05259787` - EP Intravenous Anesthesia in Hysteroscopy	Phase 4
Completed	`NCT02894996` - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?	N/A
Completed	`NCT05386082` - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated	`NCT03567928` - Laryngeal Mask in Upper Gastrointestinal Procedures	N/A
Recruiting	`NCT06074471` - Motor Sparing Supraclavicular Block	N/A
Completed	`NCT04163848` - CARbon Impact of aNesthesic Gas

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.