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

NCT ID: NCT07016022

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-07-01

Brief Summary

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.

Conditions

Thoracic Cancer; Complication,Postoperative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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 mobility by having the participant perform certain tasks such as sitting, standing, deep breathing, valsalva manoeuvres, and marching.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew JE Seely, MD, PhD, FRSCS

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Central Contacts

Andrew JE Seely, MD,PhD,FRSCS

Role: CONTACT

aseely@toh.ca

713-737-8899 ext. 74052

Daniel G Jones, MD,MPH,FRCSC

Role: CONTACT

danijones@toh.ca

613-737-8899 ext. 74053

Other Identifiers

20250214-01H

Identifier Type: -

Identifier Source: org_study_id