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Esophageal Balloon Calibration in Assisted Ventilation Mode

Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03721237
Acronym
EBC-PSV+Sigh
Enrollment
20
Registered
2018-10-26
Start date
2018-11-15
Completion date
2019-08-01
Last updated
2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Pressure High, Respiratory Failure

Keywords

Esophageal catheter calibration, Assisted mechanical ventilation

Brief 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.

Detailed description

Assisted ventilatory modes, nowadays, have been proved to reduce complications related to controlled mechanical ventilation. With these modes, ventilatory cycling is under the patient's control to an extent depending on the type of ventilatory modality. Sigh improves oxygenation and lung mechanics during pressure control ventilation and pressure support ventilation (PSV) in patients with acute respiratory distress syndrome. In order to better quantify the effects of both PSV and PSV plus Sigh on respiratory mechanics, the esophageal pressure monitoring could be helpful. However, esophageal pressure (Pes) assessment requires esophageal ballon calibration (EBC) as demonstrated in intubated patients under controlled mechanical ventilation. At our knowledge, no data exist about EBC during assisted ventilatory modes. The primary aim of the present study is to evaluate the effects of PSV and PSV plus Sigh ventilation on esophageal balloon best volume in patients admitted to the intensive care unit for acute respiratory failure. .

Interventions

OTHEREBC-assisted

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).

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients older than 18 years; * undergoing mechanical ventilation for more than 24 hours (in volume-controlled mode) and with readiness to run assisted ventilation;

Exclusion criteria

* severe COPD with air trapping clinical suspicion; * hemodynamic instability requiring inotropic or vasopressor support; * any contraindications to esophageal catheter positioning

Design outcomes

Primary

MeasureTime frameDescription
Effects of ventilatory mode on calibrated esophageal ballon best volumeOver 120 minutes in PSVEvaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes
Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + SighOver 30 minutes in PSV + SighEvaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh

Secondary

MeasureTime frameDescription
Changes of respiratory mechanics indices in PSVover 30 minutes in PSVlung, chest wall and respiratory system elastance (cmH2O/l)
Changes of respiratory mechanics indices in PSV + sighover 30 minutes in PSV + Sighlung, chest wall and respiratory system elastance (cmH2O/l)
Gas exchangeover 30 minutes during each trialPaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026