NCT Number: NCT07016022
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ottawa, Ontario, K1H 8L6, Canada
Location status: Recruiting
Andrew JE Seely, MD,PhD,FRSCS
PRINCIPAL_INVESTIGATOR
Anna Fazekas
CONTACT
613-737-8899 ext. 72841
Daniel G Jones, MD,MPH,FRCSC
SUB_INVESTIGATOR
Dora Kusevic, BSc
CONTACT
613-737-8899 ext. 74020
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
Time frame: Upon study completion, 10 months after study initiation
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.
Contact information is provided by the study sponsor or research team.
Andrew JE Seely, MD,PhD,FRSCS
CONTACT
713-737-8899 ext. 74052
Daniel G Jones, MD,MPH,FRCSC
CONTACT
613-737-8899 ext. 74053
Ottawa Hospital Research Institute
Other
Acronym: CPVA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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