Esophageal Balloon Calibration in Assisted Ventilation Mode (EBC-PSV+Sigh)
Primary Purpose
Respiratory Failure, Mechanical Ventilation Pressure High
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EBC-assisted
Sponsored by
About this trial
This is an interventional other trial for Respiratory Failure focused on measuring Esophageal catheter calibration, Assisted mechanical ventilation
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
Sites / Locations
- A.O.U Maggiore della Carità
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EBC-assisted
Arm 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.
Outcomes
Primary Outcome Measures
Effects of ventilatory mode on calibrated esophageal ballon best volume
Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes
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
Secondary Outcome Measures
Changes of respiratory mechanics indices in PSV
lung, chest wall and respiratory system elastance (cmH2O/l)
Changes of respiratory mechanics indices in PSV + sigh
lung, chest wall and respiratory system elastance (cmH2O/l)
Gas exchange
PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs.
Full Information
NCT ID
NCT03721237
First Posted
October 19, 2018
Last Updated
September 3, 2019
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
1. Study Identification
Unique Protocol Identification Number
NCT03721237
Brief Title
Esophageal Balloon Calibration in Assisted Ventilation Mode
Acronym
EBC-PSV+Sigh
Official Title
Esophageal Balloon Calibration During Assisted Ventilation Modes and Sigh: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Mechanical Ventilation Pressure High
Keywords
Esophageal catheter calibration, Assisted mechanical ventilation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EBC-assisted
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
EBC-assisted
Intervention 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).
Primary Outcome Measure Information:
Title
Effects of ventilatory mode on calibrated esophageal ballon best volume
Description
Evaluation of changes of esophageal balloon best volume (ml) induced by ventilatory modes
Time Frame
Over 120 minutes in PSV
Title
Number of patients in who esophageal balloon calibration is performed (feasibility) during PSV + Sigh
Description
Evaluate the feasibility of esophageal catheter calibration during assisted ventilation modes during PSV + Sigh
Time Frame
Over 30 minutes in PSV + Sigh
Secondary Outcome Measure Information:
Title
Changes of respiratory mechanics indices in PSV
Description
lung, chest wall and respiratory system elastance (cmH2O/l)
Time Frame
over 30 minutes in PSV
Title
Changes of respiratory mechanics indices in PSV + sigh
Description
lung, chest wall and respiratory system elastance (cmH2O/l)
Time Frame
over 30 minutes in PSV + Sigh
Title
Gas exchange
Description
PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs.
Time Frame
over 30 minutes during each trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianmaria Cammarota, MD,PhD
Organizational Affiliation
"Maggiore della Carità" Hospital, Novara
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.U Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12493644
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.
Results Reference
background
PubMed Identifier
11964584
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.
Results Reference
background
PubMed Identifier
9351606
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. doi: 10.1164/ajrccm.156.4.97-01052.
Results Reference
background
PubMed Identifier
15469597
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. doi: 10.1186/cc2854. Epub 2004 May 7.
Results Reference
background
PubMed Identifier
16540960
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. doi: 10.1097/01.CCM.0000215515.49001.A2.
Results Reference
background
PubMed Identifier
7149443
Citation
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. doi: 10.1164/arrd.1982.126.5.788.
Results Reference
background
PubMed Identifier
27160458
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.
Results Reference
background
PubMed Identifier
27063290
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.
Results Reference
background
PubMed Identifier
28828367
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.
Results Reference
background
Learn more about this trial
Esophageal Balloon Calibration in Assisted Ventilation Mode
We'll reach out to this number within 24 hrs