Clinical trial NCT03721237: Esophageal Balloon Calibration in Assisted Ventilation Mode
Official title: Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Mechanical Ventilation Pressure High
Keywords: Esophageal catheter calibration
Assisted mechanical ventilation
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2018-10-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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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Eligibility criteria: 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

Primary outcomes:
measure: Effects of ventilatory mode on calibrated esophageal ballon best volume
timeFrame: Over 120 minutes in PSV
measure: Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh
timeFrame: Over 30 minutes in PSV + Sigh
Secondary outcomes:
measure: Changes of respiratory mechanics indices in PSV
timeFrame: over 30 minutes in PSV
measure: Changes of respiratory mechanics indices in PSV + sigh
timeFrame: over 30 minutes in PSV + Sigh
measure: Gas exchange
timeFrame: over 30 minutes during each trial
Other outcomes:
Locations:
city: Novara
country: Italy
facility: A.O.U Maggiore della Carità
Study officials:
affiliation: "Maggiore della Carità" Hospital, Novara
name: Gianmaria Cammarota, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pelosi P, Bottino N, Chiumello D, Caironi P, Panigada M, Gamberoni C, Colombo G, Bigatello LM, Gattinoni L. Sigh in supine and prone position during acute respiratory distress syndrome. Am J Respir Crit Care Med. 2003 Feb 15;167(4):521-7. doi: 10.1164/rccm.200203-198OC. Epub 2002 Dec 18.
citation: Patroniti N, Foti G, Cortinovis B, Maggioni E, Bigatello LM, Cereda M, Pesenti A. Sigh improves gas exchange and lung volume in patients with acute respiratory distress syndrome undergoing pressure support ventilation. Anesthesiology. 2002 Apr;96(4):788-94. doi: 10.1097/00000542-200204000-00004.
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citation: Bellani G, Grasselli G, Teggia-Droghi M, Mauri T, Coppadoro A, Brochard L, Pesenti A. Do spontaneous and mechanical breathing have similar effects on average transpulmonary and alveolar pressure? A clinical crossover study. Crit Care. 2016 Apr 28;20(1):142. doi: 10.1186/s13054-016-1290-9.
citation: Mojoli F, Iotti GA, Torriglia F, Pozzi M, Volta CA, Bianzina S, Braschi A, Brochard L. In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable. Crit Care. 2016 Apr 11;20:98. doi: 10.1186/s13054-016-1278-5.
citation: Mauri T, Cambiaghi B, Spinelli E, Langer T, Grasselli G. Spontaneous breathing: a double-edged sword to handle with care. Ann Transl Med. 2017 Jul;5(14):292. doi: 10.21037/atm.2017.06.55.