Work

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

Year: 2024

Type: preprint

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.

Source: medRxiv

DOI: 10.1101/2024.01.24.24301611