Distensibility Index of Inferior Vena Cava in Assessing Fluid Responsiveness: The Impact of Spontaneous Respiratory Effort

NCT07644494 | Completed

• 1 other identifier: 2022ZDSYLL328-P01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shock

Keywords

Shock, Fluid Responsiveness, Inferior Vena Cava, Spontaneous Breathing Effort, Ultrasound

Outcome Measures

Primary Outcomes (1)

• inspiratory effort affects the accuracy of the distensibility index of inferior vena cava in assessing fluid responsiveness

  immediate

Interventions

explored how inspiratory effort affects the accuracy of the distensibility index of inferior vena cava in assessing fluid responsiveness BEHAVIORAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• were pregnant;
• were younger than 18 years of age;
• 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\[16\];
• expected to die within 24 hours;
• had family members of the patient declined enrollment.

Sponsors & Collaborators

• Jingyuan,Xu: lead

Study Sites (1)

Zhongda hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Zhongda Hospital

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

CN (1)