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Not Yet RecruitingNCT07016022

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
130 (estimated)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERCardioPulmonary 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.

Timeline

Start date
2025-07-01
Primary completion
2026-05-01
Completion
2026-07-01
First posted
2025-06-11
Last updated
2025-06-19

Source: ClinicalTrials.gov record NCT07016022. Inclusion in this directory is not an endorsement.