CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
EBC-assistedother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03721237
NCT03721237N/ACompleted
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Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study

Azienda Ospedaliero Universitaria Maggiore della Carita·interventional·Posted Oct 26, 2018·Updated Sep 4, 2019

In Brief

A clinical study evaluating EBC-assisted for Respiratory Failure and Mechanical Ventilation Pressure High. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Esophageal balloon calibration (EBC) has been proposed during controlled mechanical ventilation in intubated patients in order to optimize esophageal pressure (Pes) signal. Actually, at our knowledge, no data exist about EBC during assisted ventilatory modes such as Pressure Support Ventilation (PSV). The primary endpoint of the present investigation is to assess the feasibility of EBC during PSV and PSV plus Sigh.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Failure, Mechanical Ventilation Pressure High
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 26, 2018
Enrollment StartNov 15, 2018
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.7 years ago

Interventions

EBC-assistedother

After definitive catheter positioning, esophageal balloon calibration will be performed in: 1. volume-controlled mode with tidal volume set to obtain 6-8 lm/kg of ideal body weight (reference), 2. pressure support ventilation (PSV) with support set to obtain a tidal volume ranging between 6-8 ml/kg of ideal body weight at equal PEEP of volume control mode (PSV baseline); 3. PSV + sigh ventilation (sigh setting: total inspiratory pressure equal to 35 cmH2O at a rate of 1/ minute; inspiratory time equal to 4 seconds).