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.
Trial Registration ClinicalTrials.gov Registration: #NCT05743673. Principal Investigator: Zyad J. Carr, M.D. Date of Registration: 5-12-2023.
Strengths and limitations of this study
We examined patient-and logistic-centered acceptance of study procedures within the environment of a high-volume preoperative surgical evaluation clinic.
Study procedures were well tolerated, and participants readily accepted submaximal cardiopulmonary exercise testing with high satisfaction with device use, scheduling, and perceived exertion.
User operational efficiency developed over 10-15 sessions of use.
This feasibility study met our proposed endpoints but is comprised of a small sample of participants, limiting its generalizability to larger populations.
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.
Yes
Data Availability
All data produced in the present study are available upon reasonable request to the authors