Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CardioPulmonary Variability Assessment.
- Who it may be relevant to
- Registry conditions: Thoracic Cancer, Complication,Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Major thoracic surgery is high risk as it carries a significant risk of postoperative Adverse Events (AEs), where patients experience complications and do not recover as expected. These AEs can increase the risk of mortality, hospital length of stay, as well as healthcare costs. The investigators' aim is to improve surgical safety by pioneering a marked advance in preoperative prediction of postoperative AEs that will enable individualized targeted perioperative pathways to prevent postoperative AEs. Given that illness and stress are associated with a loss in physiologic variability (e.g. heart and respiration rate), the investigators will use heart and lung variability assessments to improve prediction of postoperative AEs. Therefore, this study aims to assess the feasibility of implementing a preoperative CardioPulmonary variability assessment; determine if preoperative CardioPulmonary variability is associated with postoperative AEs; and determine if this variability assessment is superior and complementary to existing measures of risk and frailty.
Interventions
- Other CardioPulmonary Variability Assessment
The Preoperative CardioPulmonary Variability Assessment (CPVA) will assess baseline HRV \& RRV and the ability to tolerate mild physiologic stress. The assessment will involve a a Philips MP50 monitor that will collect continuous ECG (Lead II) and CO2-based respiratory waveform data with intermittent blood pressure (BP) measurements over a test of less than 60 minutes. We will measure the response to mild physiological stress which reflects adaptability, autonomic function and functional mobilit
Primary outcome measures
- Feasibility of implementing CPVA testing in thoracic surgery patients [Time frame: Upon study completion, 10 months after study initiation]
- Statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs [Time frame: Upon study completion, 10 months after study initiation]
Secondary outcome measures (1)
- Assess predictive power of CPVA indices [Time frame: Upon study completion, 10 months after study initiation]
Eligibility criteria
Inclusion criteria
- Adult patient (≥18 years of age)
- Patients undergoing major thoracic resection for lung, esophageal or gastric cancer or mediastinal tumour (at least lobectomy, pneumonectomy, esophagectomy, gastrectomy, or mediastinal tumour resection)
Exclusion criteria
- Urgent/emergent cases
- Patients with pre-existing atrial fibrillation or arrhythmia (persistent/paroxysmal)
- Patients that are pacemaker dependent
- Patients unable to participate in preoperative testing protocol (CardioPulmonary Variability Assessment)
- Patients that are pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- The Ottawa Hospital — Ottawa
Identifiers
NCT: NCT07016022 · 20250214-01H