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

NCT07016022 | Recruiting

• 1 other identifier: 20250214-01H
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Assess predictive power of CPVA indices

  Upon study completion, 10 months after study initiation

Interventions

CardioPulmonary Variability Assessment OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew JE Seely, MD, PhD, FRSCS

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew JE Seely, MD,PhD,FRSCS

CONTACT

713-737-8899; aseely@toh.ca

Daniel G Jones, MD,MPH,FRCSC

CONTACT

613-737-8899; danijones@toh.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)