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Completed

NCT Number: NCT03721237

Esophageal Balloon Calibration in Assisted Ventilation Mode

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.O.U Maggiore della Carità

Novara, 28100, Italy

About this study

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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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EBC-assisted

Other

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).

Primary outcomes

  1. Effects of ventilatory mode on calibrated esophageal ballon best volume

    Time frame: Over 120 minutes in PSV

    Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes

  2. Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh

    Time frame: Over 30 minutes in PSV + Sigh

    Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh

Secondary outcomes

  1. Changes of respiratory mechanics indices in PSV

    Time frame: over 30 minutes in PSV

    lung, chest wall and respiratory system elastance (cmH2O/l)

  2. Changes of respiratory mechanics indices in PSV + sigh

    Time frame: over 30 minutes in PSV + Sigh

    lung, chest wall and respiratory system elastance (cmH2O/l)

  3. Gas exchange

    Time frame: over 30 minutes during each trial

    PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Official study title

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

Acronym: EBC-PSV+Sigh

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 26, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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