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

ObjectivesWe tested the logistic feasibility of integrating brief submaximal cardiopulmonary exercise testing (smCPET) in a pre-surgical evaluation (PSE) clinic. DesignProspective open-label clinical device trial. SettingPre-surgical evaluation clinic. Participants43 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. InterventionsPre-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. ResultsSession 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. ConclusionsOur 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 RegistrationClinicalTrials.gov Registration: #NCT05743673. Principal Investigator: Zyad J. Carr, M.D. Date of Registration: 5-12-2023. Strengths and limitations of this studyO_LIWe examined patient-and logistic-centered acceptance of study procedures within the environment of a high-volume preoperative surgical evaluation clinic. C_LIO_LIStudy procedures were well tolerated, and participants readily accepted submaximal cardiopulmonary exercise testing with high satisfaction with device use, scheduling, and perceived exertion. C_LIO_LIUser operational efficiency developed over 10-15 sessions of use. C_LIO_LIThis feasibility study met our proposed endpoints but is comprised of a small sample of participants, limiting its generalizability to larger populations. C_LI