Pre-surgery heart and breathing variability to spot risk of complications after major thoracic cancer surgery.
Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
This project will test whether a quick pre-surgery check of heart and breathing variability can help predict which adults having major thoracic cancer operations are more likely to have postoperative complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT07016022 on ClinicalTrials.gov |
What this trial studies
This observational study will perform a preoperative CardioPulmonary Variability Assessment—measuring heart rate and respiratory variability—on adults scheduled for major thoracic resections for lung, esophageal, gastric cancer, or mediastinal tumors. Researchers will follow patients through surgery and the postoperative period to record adverse events, length of stay, and other outcomes. The aims are to test feasibility of the preoperative measure, determine whether reduced cardio-pulmonary variability is associated with postoperative adverse events, and explore whether the measure improves risk prediction beyond current clinical factors. Key exclusions include urgent/emergent cases, pre-existing atrial arrhythmias or pacemaker dependence, pregnancy, and inability to complete the preoperative testing protocol.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for major thoracic cancer operations such as lobectomy, pneumonectomy, esophagectomy, gastrectomy, or mediastinal tumor resection who can complete the preoperative variability testing.
Not a fit: Patients with pre-existing atrial fibrillation or other arrhythmias, pacemaker dependence, urgent/emergent operations, pregnancy, or who cannot complete the preoperative test are unlikely to benefit from this assessment.
Why it matters
Potential benefit: If successful, this could let clinicians identify higher-risk patients before surgery so they can tailor perioperative care to reduce complications and shorten hospital stays.
How similar studies have performed: Prior studies have linked reduced heart-rate and respiratory variability to worse outcomes in critical illness and some surgical settings, but applying a combined CardioPulmonary variability check specifically to predict postoperative events after thoracic cancer surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Andrew JE Seely, MD, PhD, FRSCS — The Ottawa Hospital
- Study coordinator: Andrew JE Seely, MD,PhD,FRSCS
- Email: aseely@toh.ca
- Phone: 713-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.