Distensibility Index of Inferior Vena Cava in Assessing Fluid Responsiveness: The Impact of Spont… (NCT07644494) | Clinical Trial Compass
CompletedNot Applicable
Distensibility Index of Inferior Vena Cava in Assessing Fluid Responsiveness: The Impact of Spontaneous Respiratory Effort
China50 participantsStarted 2024-06-01
Plain-language summary
This study explored how inspiratory effort affects the accuracy of the distensibility index of inferior vena cava (dIVC) in assessing fluid responsiveness (FR).This prospective observational study was conducted in an intensive care unit of a university hospital and included shock patients receiving ventilation with spontaneous breathing activity. Hemodynamic parameters were collected before and after fluid challenge by the pulse indicator continuous cardiac output. dIVC was calculated by ultrasound, and respiratory effort was assessed using airway occlusion pressure (P0.1) and end-expiratory occlusion pressure (Pocc) before fluid administration. Responders were defined by a ≥10% increase in cardiac output (CO) after 250 mL saline infused in 10 minutes. The dIVC \> 18% was considered indicative of FR. Predictive performance was evaluated using area under receiver operating characteristic curves (AUROC), stratified by P0.1 and Pocc.
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion criteria
. defined as shock who has the presence of systolic blood pressure (SBP) ≤ 90 or a \> 40 mmHg decline of SBP in patients known to be hypertensive or mean arterial pressure (MAP) ≤ 70 mmHg or requiring vasopressors to maintain SBP \> 90 mmHg or MAP \> 70 mmHg, along with signs of hypoperfusion (urinary flow \< 0.5 ml/kg/min for \> 2 h, or presence of skin mottling or blood lactate concentration ≥ 2.0 mmol/L);
. received mechanical ventilation;
. had the Pulse Indicator Continuous Cardiac Output (PiCCO) catheter for hemodynamic monitoring；
. had the sign of fluid administration which include: (a) MAP \< 65 mmHg and/or SBP \< 90 mmHg; (b) the need for vasopressors; (c) urinary flow \< 0.5 ml/kg/min for \>2 h; (d) tachycardia; (e) lactic acidosis; or (f) delayed capillary refilling.
Exclusion criteria
Questions worth asking your doctor
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
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3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
inspiratory effort affects the accuracy of the distensibility index of inferior vena cava in assessing fluid responsiveness
. could not have spontaneous respiratory drive or effort measured;
. had intra-abdominal pressure ≥ 16 cmH₂O \[15\];
. had conditions affecting dIVC measurement, such as ECMO cannulation;
. had factors precluding clear ultrasound imaging;
. defined as right ventricular dysfunction who has (a) tricuspid annular plane systolic excursion \< 16 mm; (b) moderate or greater tricuspid regurgitation; (c) moderate or greater pulmonary artery hypertension\[16\];