Recruiting

CardioPulmonary Variability

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT07016022

Conditions

Thoracic Cancer

Complication,Postoperative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CardioPulmonary Variability Assessment

Study Details

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 ID

NCT07016022

Start date

Jul 1, 2025

Status verified date

Apr, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

May 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

130 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Andrew JE Seely, MD,PhD,FRSCS

713-737-8899aseely@toh.ca

Daniel G Jones, MD,MPH,FRCSC

613-737-8899danijones@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Principal Investigator:

Andrew JE Seely, MD,PhD,FRSCS

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-05-01.