An Open-label Clinical Study of Brief Submaximal Cardiopulmonary Testing in Pre-surgical Evaluation: Feasibility of implementation

Abstract

Objectives: We tested the logistic feasibility of integrating brief submaximal cardiopulmonary exercise testing (smCPET) in a pre-surgical evaluation (PSE) clinic. Design: Prospective open-label clinical device trial. Setting: Pre-surgical evaluation clinic. Participants: 43 participants who met criteria of i) age > 60 years old, ii) revised cardiac risk index of <2, iii) self-reported metabolic equivalents (METs) of >4.6 (i.e. ability to climb 2 flights of stairs), and iv) presenting for noncardiac surgery. Interventions: Pre-intervention self-reported METs, Duke Activity Status Index (DASI) surveys, smCPET trial, Borg survey of perceived exertion, and post-intervention survey. Measurements: Feasibility endpoints were 1) operational efficiency as measured by length of time of experimental session < 20 minutes, 2) no more than moderate perceived physical exertion as quantified by a modified Borg survey of perceived exertion of <7 in the absence of observed complications, 3) high participant satisfaction with smCPET task execution, represented as a score of >8, and 4) high patient satisfaction with scheduling of smCPET testing, represented as a score of >8. Results: Session time was 16.9 minutes (+/-6.8). Post-test modified Borg survey was 5.35 (+/-1.8), corresponding to moderate perceived exertion. Satisfaction [on a scale of 1 (worst) to 10 (best)] regarding ease of smCPET tasks was 9.6 (+/-0.7) and mean patient satisfaction with smCPET scheduling was 9.5 (+/-1.5). Operational efficiency was achieved after 10-15 experimental sessions. Conclusions: Our findings suggest that smCPET integration in a PSE clinic; 1) is time efficient 2) shows high participant satisfaction with task, and 3) rapidly achieved operational efficiency.

Competing Interest Statement

The listed authors would like to disclose the following affiliations or involvements: ZJC receives partial funding from Shape Medical Systems, Inc. (Minnesota, USA) related to the present work. RBS reports owning stock in Johnson and Johnson unrelated to the present work. RBS reports that Yale University has received funding from Merck for a study in which he was involved, unrelated to the present work. PH reported receiving research support grants from Edwards Lifesciences and consulting and/or royalty fees from Baudax Bio, Fire1Foundry, Cardiage LLC, and Edwards Lifesciences. related to the present work. RBS reports owning stock in Johnson and Johnson unrelated to the 319 present work. RBS reports that Yale University has received funding from Merck for a study in 320 which he was involved, unrelated to the present work. PH reported receiving research support 321 grants from Edwards Lifesciences and consulting and/or royalty fees from Baudax Bio, 322 Fire1Foundry, Cardiage LLC, and Edwards Lifesciences.

Clinical Trial

ClinicalTrials.gov Registry. #NCT05743673

Funding Statement

This study was partially supported by Shape Medical Systems, Inc. (Minnesota, USA).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This is an ongoing prospective open-label clinical device trial approved by the Yale University Institutional Review Board (IRB#2000033885; ClinicalTrials.gov Registry. #NCT05743673. Principal Investigator: Zyad J. Carr, M.D. Date of Registration: 5-12-2023).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

All data produced in the present study are available upon reasonable request to the authors

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