ClinicalTrials.gg
CompletedNCT07644494Updated Jun 12, 2026

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

An observational study in Shock, sponsored by Jingyuan,Xu. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Jingyuan,Xu · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Shock

Browse trials for

Keywords

  • Shock, Fluid Responsiveness, Inferior Vena Cava, Spontaneous Breathing Effort, Ultrasound
03

In context

Shock

487 studies on the registry are indexed under Shock; 107 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 247 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Jingyuan,Xu is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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);
  2. received mechanical ventilation;
  3. had the Pulse Indicator Continuous Cardiac Output (PiCCO) catheter for hemodynamic monitoring;
  4. 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

Exclusion Criteria:

  1. were pregnant;
  2. were younger than 18 years of age;
  3. could not have spontaneous respiratory drive or effort measured;
  4. had intra-abdominal pressure ≥ 16 cmH₂O [15];
  5. had conditions affecting dIVC measurement, such as ECMO cannulation;
  6. had factors precluding clear ultrasound imaging;
  7. 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];
  8. expected to die within 24 hours;
  9. had family members of the patient declined enrollment.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • Behavioralexplored how inspiratory effort affects the accuracy of the distensibility index of inferior vena cava in assessing fluid responsiveness
06

What researchers measure

Primary outcomes

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

    Time frame: immediate

07

Study locations

1 site
  • Zhongda hospital
    Nanjing, Jiangsu, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Mar 2025, 9 months.

Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's 9 months is below that.

Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2026
First posted
Jun 12, 2026
StartActual
Jun 1, 2024
Primary completionActual
Mar 31, 2025
CompletionActual
May 31, 2025
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07644494
Lead sponsor
Jingyuan,Xu
Responsible party
Jingyuan,Xu (Zhongda Hospital, Southeast University, China) — Sponsor-investigator
First posted
Jun 12, 2026
Start date
Jun 1, 2024
Primary completion
Mar 31, 2025
Completion
May 31, 2025
Last update
Jun 12, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion