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Cardiac disease complicated by respiratory insufficiency comprises the most frequent indication for cardiac intensive care unit (CICU) admission, with nearly one-third patients requiring advanced respiratory support and over 20% patients requiring invasive mechanical ventilation (IMV). IMV among patients with impaired cardiovascular reserve is further compounded by the adverse impact of positive pressure ventilation (PPV) and systemic sedation on intracardiac hemodynamics, pulmonary vascular mechanics and consequently end-organ perfusion. Despite widespread use, evidence guiding optimal ventilatory practices and mode selection in cardiovascular intensive care unit patients remains limited. Pressure-controlled and volume-controlled ventilation may differ in their effects on patient-ventilator synchrony, sedation requirements, and hemodynamic impact, but comparative data among patients with critical cardiac disease remains inconclusive. This pilot study will evaluate the feasibility of implementing a pragmatic cluster-randomized crossover trial comparing ventilatory modes in a contemporary cardiovascular intensive care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pressure Controlled Ventilation | Active Comparator | During invasive mechanical ventilation in the cardiac ICU, pressure-controlled ventilation will be used as the mode for continuous mandatory ventilation. |
|
| Volume-Controlled Ventilation | Active Comparator | During invasive mechanical ventilation in the cardiac ICU, volume-controlled ventilation will be used as the mode for continuous mandatory ventilation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volume Controlled Mode | Other | Volume-controlled mode for continuous mandatory ventilation with preset inspiratory flow and tidal volume. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherance to assigned study mode (Feasibility Outcome) | Percentage of time spent on the assigned study mode while receiving invasive mechanical ventilation in the cardiac ICU between enrollment and 48 hours after enrollment. | Enrollment to 48 hours |
| Time From Enrollment to Initiation of Assigned Mode of Mechanical Ventilation (Feasibility Outcome) | Time (number of hours) taken to initiate participants from enrollment (cardiac ICU admission) to initiation of assigned study mode of invasive mechanical ventilation upto 48 hours after enrollment. | Enrollment to 48 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital Mortality (Exploratory Clinical Outcome) | All-cause, 28-day, in-hospital mortality, defined as death from any cause occurring between enrollment and 28 days after enrollment. | Enrollment to Study Day 28 |
| Ventilator-Free Days (Exploratory Clinical Outcome) |
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Inclusion Criteria:
Eligible adults ≥ 18 years of age admitted to the cardiac ICU with need for invasive mechanical ventilation of expected duration >12 hours.
Pre-Specified Subgroups for exploratory outcomes:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic, 1216 Second Street SW | Recruiting | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39417127 | Background | Seitz KP, Lloyd BD, Wang L, Shotwell MS, Qian ET, Muhs AL, Richardson RK, Rooks JC, Hennings-Williams V, Sandoval CE, Richardson WD, Morgan TL, Thompson AN, Hastings PG, Ring TP, Stollings JL, Talbot EM, Krasinski DJ, DeCoursey BR, Marvi TK, DeMasi SC, Gibbs KW, Self WH, Mixon AS, Rice TW, Semler MW; Pragmatic Critical Care Research Group. Effect of Ventilator Mode on Ventilator-Free Days in Critically Ill Adults: A Randomized Trial. medRxiv [Preprint]. 2024 Oct 9:2024.10.08.24314961. doi: 10.1101/2024.10.08.24314961. | |
| 34117278 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D016638 | Critical Illness |
| D012770 | Shock, Cardiogenic |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| Pressure Controlled Mode | Other | Pressure-controlled mode for continuous mandatory ventilation with preset inspiratory pressure above positive end-expiratory pressure. |
|
The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation. |
| Enrollment to Study Day 28 |
| Organ Failure Free Survival Days (Exploratory Clinical Outcome) | The number of calendar days between enrollment and 28 days after enrollment, on which the patient is alive and free of invasive mechanical ventilation, renal replacement therapy, mechanical circulatory and vasoactive medication support. | Enrollment to Study Day 28 |
| Vasoactive-inotrope score (Exploratory Hemodynamic Outcome) | The Vasoactive-Inotropic Score (VIS) is a quantitative measure of the total cardiovascular support a patient receives through vasopressors and inotropes, by a standardized conversion to per-kilogram per-minute units. Higher VIS indicates greater dependence on pharmacologic support and is associated with worse outcomes. | Enrollment to 48 hours |
| Intensive Care Unit Length of Stay (Exploratory Clinical Outcome) | Number of days between enrollment and 28 days after enrollment, on which the patient is alive and free from intensive care unit admission after the final transfer out of the intensive care unit | Enrollment to Study Day 28 |
| Patient Ventilator Dyssynchrony Events | Number of participants with flow, trigger or cycle dyssynchrony during assigned study mode for invasive mechanical ventilation. | Enrollment to 48 hours |
| Exhaled Tidal Volume (mL/kg Predicted Body Weight) (Exploratory Ventilatory Outcome) | Measured in mL/kg of predicted body weight | Enrollment to 48 hours |
| Median RASS Score (Exploratory Safety Outcome) | RASS is a 10-point scale of agitation or sedation ranging from -5 (most sedated, comatose) to +4 (most agitated, combative). The sedation requirement for each ventilator mode will be assessed via RASS score. | Enrollment to 48 hours |
| Background |
| Zhou Y, Holets SR, Li M, Cortes-Puentes GA, Meyer TJ, Hanson AC, Schulte PJ, Oeckler RA. Etiology, incidence, and outcomes of patient-ventilator asynchrony in critically-ill patients undergoing invasive mechanical ventilation. Sci Rep. 2021 Jun 11;11(1):12390. doi: 10.1038/s41598-021-90013-z. |
| 24447503 | Background | Al Shehri AM, El-Tahan MR, Al Metwally R, Qutub H, El Ghoneimy YF, Regal MA, Zien H. Right ventricular function during one-lung ventilation: effects of pressure-controlled and volume-controlled ventilation. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):880-4. doi: 10.1053/j.jvca.2013.09.012. Epub 2014 Jan 18. |
| 27581657 | Background | Kim KN, Kim DW, Jeong MA, Sin YH, Lee SK. Comparison of pressure-controlled ventilation with volume-controlled ventilation during one-lung ventilation: a systematic review and meta-analysis. BMC Anesthesiol. 2016 Aug 31;16(1):72. doi: 10.1186/s12871-016-0238-6. |
| 38105126 | Background | Li XF, Mao WJ, Jiang RJ, Yu H, Zhang MQ, Yu H. Effect of Mechanical Ventilation Mode Type on Postoperative Pulmonary Complications After Cardiac Surgery: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Feb;38(2):437-444. doi: 10.1053/j.jvca.2023.11.024. Epub 2023 Nov 19. |
| 25927671 | Background | Rittayamai N, Katsios CM, Beloncle F, Friedrich JO, Mancebo J, Brochard L. Pressure-Controlled vs Volume-Controlled Ventilation in Acute Respiratory Failure: A Physiology-Based Narrative and Systematic Review. Chest. 2015 Aug;148(2):340-355. doi: 10.1378/chest.14-3169. |
| 30236315 | Background | Alviar CL, Miller PE, McAreavey D, Katz JN, Lee B, Moriyama B, Soble J, van Diepen S, Solomon MA, Morrow DA; ACC Critical Care Cardiology Working Group. Positive Pressure Ventilation in the Cardiac Intensive Care Unit. J Am Coll Cardiol. 2018 Sep 25;72(13):1532-1553. doi: 10.1016/j.jacc.2018.06.074. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
| D012769 | Shock |