CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Tidal volume challenge +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04457739
NCT04457739N/ACompleted
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Evaluation of Tidal Volume Challenge to Detect Preload-responsiveness in Patients With Acute Respiratory Distress Syndrome (ARDS) During Prone Position

Bicetre Hospital·observational·Posted Jul 7, 2020·Updated Mar 2, 2022

In Brief

An observational study evaluating Tidal volume challenge, End-expiratory occlusion test, and 1 other intervention for Acute Respiratory Distress Syndrome and 2 related conditions. Completed, enrolled 58 participants across 1 site.

Detailed Summary

Evaluation of preload responsiveness in ARDS patients during prone position is difficult and only one study showed Trendelenburg manoeuvre can be used in this group of patients. This study aims to investigate whether end-expiratory occlusion test, tidal volume challenge (using the changes in PPV) can be used to evaluate preload responsiveness in patients with ARDS ventilated with a low tidal volume and who underwent a PP session.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome, Septic Shock, Hemodynamic Instability
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 7, 2020
Enrollment StartJan 8, 2019
Primary CompletionMay 6, 2021
Study CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.0 years ago

Interventions

Tidal volume challengeother

Increasing tidal volume from 6 to 8 mL/kg during 1 min

End-expiratory occlusion testother

Interrupting the ventilator at end-expiration for 15-30 s and assessing the resulting changes in cardiac output

Trendelenburg maneuverother

Patients remained in prone position with a 13° upward bed angulation throughout the study and then be positioned in a declining position at -12 ° for 1 minute