Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery (CPVA)

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Cancer; Complication,Postoperative
• Intervention / Treatment: Other: CardioPulmonary Variability Assessment

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Andrew JE Seely, MD,PhD,FRSCS; Phone Number: 74052 713-737-8899; Email: aseely@toh.ca
• Study Contact Backup: Name: Daniel G Jones, MD,MPH,FRCSC; Phone Number: 74053 613-737-8899; Email: danijones@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Contact: Anna Fazekas; Phone Number: 72841 613-737-8899; Email: afazekas@toh.ca
      • Contact: Dora Kusevic, BSc; Phone Number: 74020 613-737-8899; Email: dkusevic@toh.ca
      • Principal Investigator: Andrew JE Seely, MD,PhD,FRSCS
      • Sub-Investigator: Daniel G Jones, MD,MPH,FRCSC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing major thoracic surgery who have no history of atrial fibrillation or arrhythmia, are not pacemaker dependent, and are not pregnant.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing CPVA testing in thoracic surgery patients	Implementing CPVA testing in thoracic surgery patients will be considered feasible if: >50% of identified eligible patients are enrolled and consented, >90% of consented and enrolled patients complete CPVA testing protocol There is adequate data analysis from the CPVA in >90% of patients that complete the CPVA protocol >95% of CRFs are complete	Upon study completion, 10 months after study initiation
Statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs	The statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs will be determined by separating the patient's into subgroups based on (a) any AEs (any class), (b) serious AEs (Class III and above), (c) the type of AEs they experience (including POPCs, atrial fibrillation, air leak) and performing statistical analyses to determine if there is a significance between patients who experience AEs and those who don't based on the CPVA metrics.	Upon study completion, 10 months after study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess predictive power of CPVA indices	A simple univariate logistic regression model will be created for each variability metric and literature-based thresholds will be used for the CPVA indices to assess their predictive power, which will be compared to that of the current predictor for the 3 types of AEs (POPC, arrhythmia, air leak). For each AE, a multiple logistic regression using the original predictors and variability features will also be performed to assess the added value of the variability features.	Upon study completion, 10 months after study initiation

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Andrew JE Seely, MD, PhD, FRSCS, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 3, 2025
• First Submitted That Met QC Criteria: June 3, 2025
• First Posted (Actual): June 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 20250214-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No