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Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation

NCT04924920 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-02

No results posted yet for this study

Summary

The application of a brief SIGH of 4 seconds at 35 cmH20 has shown to reliably predict fluid responsiveness in critically ill patients undergoing pressure support ventilation.

The end-expiratory occlusion test (EEOT) has been also used in the same type of patients, with the same purpose, but in a limited amount of studies.

The aim of this study is to compare the reliability of the the two test in assessing fluid responsiveness.

Conditions

  • Critically Ill Patients
  • Hemodynamic Instability
  • Mechanical Ventilation Pressure High

Interventions

DIAGNOSTIC_TEST

SIGH

To add the Sigh35 to PSV, the ventilator is set in pressure controlled synchronized intermittent mandatory ventilation plus PSV \[SIMV (PC) + PS mode\], with SIMV rate set a 1/min and inspiratory time of 4 seconds. SIMV (PC) = 35 cmH20 of total inspiratory support (PEEP + PS).

DIAGNOSTIC_TEST

EEOT

• The EEOT is performed by interrupting the mechanical ventilation for 15 seconds, by using and end-expiratory hold on the ventilator. The ventilator trigger is set at 2 L/min.

DIAGNOSTIC_TEST

Fluid challenge

Bolus of fluids of 4 ml/kg given within 10 minutes

Sponsors & Collaborators

  • Humanitas Clinical and Research Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04924920 on ClinicalTrials.gov