Esophageal Balloon Calibration in Assisted Ventilation Mode

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


Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Source 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.


Overall Status Completed
Start Date November 15, 2018
Completion Date August 1, 2019
Primary Completion Date August 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Effects of ventilatory mode on calibrated esophageal ballon best volume Over 120 minutes in PSV
Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh Over 30 minutes in PSV + Sigh
Secondary Outcome
Measure Time Frame
Changes of respiratory mechanics indices in PSV over 30 minutes in PSV
Changes of respiratory mechanics indices in PSV + sigh over 30 minutes in PSV + Sigh
Gas exchange over 30 minutes during each trial
Enrollment 20

Intervention Type: Other

Intervention Name: EBC-assisted

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

Arm Group Label: EBC-assisted



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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Gianmaria Cammarota, MD,PhD Principal Investigator "Maggiore della Carità" Hospital, Novara
Facility: A.O.U Maggiore della Carità
Location Countries


Verification Date

December 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita

Investigator Full Name: Gianmaria Cammarota

Investigator Title: Physician in staff of the ICU

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: EBC-assisted

Type: Experimental

Description: 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.

Acronym EBC-PSV+Sigh
Patient Data Undecided
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)