Esophageal Balloon Calibration in Assisted Ventilation Mode (EBC-PSV+Sigh)

• ClinicalTrials.gov Identifier: NCT03721237
• Recruitment Status: Completed
• First Posted: October 26, 2018
• Last Update Posted: September 4, 2019
• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
• Information provided by (Responsible Party): Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Failure; Mechanical Ventilation Pressure High	Other: EBC-assisted	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study
• Actual Study Start Date: November 15, 2018
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: August 1, 2019

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Italy

A.O.U Maggiore della Carità

Novara, Italy, 28100

Sponsors and Collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

• Principal Investigator: Gianmaria Cammarota, MD,PhD; "Maggiore della Carità" Hospital, Novara

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

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.

• Responsible Party: Gianmaria Cammarota, Physician in staff of the ICU, Azienda Ospedaliero Universitaria Maggiore della Carita
• ClinicalTrials.gov Identifier: NCT03721237
• Other Study ID Numbers: CE 111/18
• First Posted: October 26, 2018
• Last Update Posted: September 4, 2019
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Gianmaria Cammarota, Azienda Ospedaliero Universitaria Maggiore della Carita:

Esophageal catheter calibration; Assisted mechanical ventilation

Additional relevant MeSH terms:

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases