Thoracic CancerCPVANCT07016022
Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
An observational study of Thoracic Cancer and Complication,Postoperative, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Cancer, Complication,Postoperative
- What is being tested?
- CardioPulmonary Variability Assessment
- How many people
- 130 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Anna Fazekas, 613-737-8899 ext. 72841, afazekas@toh.ca
Dora Kusevic, BSc, 613-737-8899 ext. 74020, dkusevic@toh.ca
About this study
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
- Being tested
- CardioPulmonary Variability Assessment
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioPulmonary Variability AssessmentOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Upon study completion, 10 months after study initiation
Secondary outcomes (1)
Assess predictive power of CPVA indices
A simple univariate logistic regression model will be created for each variability metric and literature-based thresholds will be used for the CPVA indices to assess their predictive power, which will be compared to that of the current predictor for the 3 types of AEs (POPC, arrhythmia, air leak). For each AE, a multiple logistic regression using the original predictors and variability features will also be performed to assess the added value of the variability features.
Measured: Upon study completion, 10 months after study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jul 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew JE Seely, MD, PhD, FRSCS, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016022
- Sponsor's protocol ID
- 20250214-01H
- Acronym
- CPVA
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability and Post-op AEs: Does Preoperative CardioPulmonary Variability Assessment Identify Risk of Postoperative Adverse Events Following Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07016022
- Acronym / sponsor ID
- CPVA / 20250214-01H
- Conditions
- Thoracic Cancer, Complication,Postoperative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioPulmonary Variability AssessmentThe 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. | Other | – |
Primary outcome
Feasibility of implementing CPVA testing in thoracic surgery patients
Time frame: Upon study completion, 10 months after study initiation
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
Statistical association between preoperative HRV and RRV and major cardiac and pulmonary postoperative AEs
Time frame: Upon study completion, 10 months after study initiation
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.
1 secondary outcome
Assess predictive power of CPVA indices
Time frame: Upon study completion, 10 months after study initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew JE Seely, MD, PhD, FRSCS principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Cancer and Complication,Postoperative, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew JE Seely, MD,PhD,FRSCS (713-737-8899 ext. 74052, aseely@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing CPVA testing in thoracic surgery patients (time frame: Upon study completion, 10 months after study initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.