Esophageal Balloon Calibration in Assisted Ventilation Mode

Not Applicable

Completed

• Conditions: Respiratory Failure; Mechanical Ventilation Pressure High
• Interventions: Other: EBC-assisted

• Registration Number: NCT03721237
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

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Study Timeline

• Study First Submitted: 2018-10-19
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Study Start: 2018-11-15
• Status Verified: 2018-12
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EBC-assisted	EBC-assisted	A nasogastric tube, equipped with esophageal and gastric balloons, will be inserted in each patient enrolled in the study. After definitive catheter positioning has been obtained, Esophageal ballon calibration will be run in volume-controlled ventilation, pressure support ventilation and sigh + pressure support ventilation.

Primary Outcome Measures

Name	Time	Method
Effects of ventilatory mode on calibrated esophageal ballon best volume	Over 120 minutes in PSV	Evaluation 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 + Sigh	Over 30 minutes in PSV + Sigh	Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh

Secondary Outcome Measures

Name	Time	Method
Gas exchange	over 30 minutes during each trial	PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs.
Changes of respiratory mechanics indices in PSV + sigh	over 30 minutes in PSV + Sigh	lung, chest wall and respiratory system elastance (cmH2O/l)
Changes of respiratory mechanics indices in PSV	over 30 minutes in PSV	lung, chest wall and respiratory system elastance (cmH2O/l)

Trial Locations

Locations (1)

A.O.U Maggiore della Carità; 🇮🇹 Novara, Italy