Esophageal Balloon Calibration in Assisted Ventilation Mode

Respiratory Failure Clinical Trial

— EBC-PSV+Sigh  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03721237
• Other study ID #: CE 111/18
• Status: Completed
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: December 2018
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation Pressure High
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• EBC-assisted
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).

Locations

Country	Name	City	State
Italy	A.O.U Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Baydur A, Behrakis PK, Zin WA, Jaeger M, Milic-Emili J. A simple method for assessing the validity of the esophageal balloon technique. Am Rev Respir Dis. 1982 Nov;126(5):788-91. — View 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. — View Citation

Gattinoni L, Chiumello D, Carlesso E, Valenza F. Bench-to-bedside review: chest wall elastance in acute lung injury/acute respiratory distress syndrome patients. Crit Care. 2004 Oct;8(5):350-5. Epub 2004 May 7. Review. — View 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. Review. — View 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. — View 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. — View 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. Epub 2002 Dec 18. — View Citation

Ranieri VM, Brienza N, Santostasi S, Puntillo F, Mascia L, Vitale N, Giuliani R, Memeo V, Bruno F, Fiore T, Brienza A, Slutsky AS. Impairment of lung and chest wall mechanics in patients with acute respiratory distress syndrome: role of abdominal distension. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1082-91. — View Citation

Talmor D, Sarge T, O'Donnell CR, Ritz R, Malhotra A, Lisbon A, Loring SH. Esophageal and transpulmonary pressures in acute respiratory failure. Crit Care Med. 2006 May;34(5):1389-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of ventilatory mode on calibrated esophageal ballon best volume	Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes	Over 120 minutes in PSV
Primary	Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh	Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh	Over 30 minutes in PSV + Sigh
Secondary	Changes of respiratory mechanics indices in PSV	lung, chest wall and respiratory system elastance (cmH2O/l)	over 30 minutes in PSV
Secondary	Changes of respiratory mechanics indices in PSV + sigh	lung, chest wall and respiratory system elastance (cmH2O/l)	over 30 minutes in PSV + Sigh
Secondary	Gas exchange	PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs.	over 30 minutes during each trial