Clinical trial NCT07016022: Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
Official title: Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Thoracic Cancer
Complication,Postoperative
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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. Our 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), we 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.


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

Primary outcomes:
measure: Feasibility of implementing CPVA testing in thoracic surgery patients
timeFrame: Upon study completion, 10 months after study initiation
measure: Statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs
timeFrame: Upon study completion, 10 months after study initiation
Secondary outcomes:
measure: Assess predictive power of CPVA indices
timeFrame: Upon study completion, 10 months after study initiation
Other outcomes:
Locations:
Study officials:
affiliation: The Ottawa Hospital
name: Andrew JE Seely, MD, PhD, FRSCS
role: PRINCIPAL_INVESTIGATOR
References: