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Respiratory FailureEBC-PSV+SighNCT03721237

Esophageal Balloon Calibration in Assisted Ventilation Mode

A study testing EBC-assisted in people with Respiratory Failure and Mechanical Ventilation Pressure High, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
EBC-assisted
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
15 Nov 2018to 1 Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients older than 18 years;
  • undergoing mechanical ventilation for more than 24 hours (in volume-controlled mode) and with readiness to run assisted ventilation;

Who cannot join

  • severe COPD with air trapping clinical suspicion;
  • hemodynamic instability requiring inotropic or vasopressor support;
  • any contraindications to esophageal catheter positioning

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • A.O.U Maggiore della Carità

    Novara, 28100

Other trials in Italy

About this study

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

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.

Read the 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.

.

Being tested
EBC-assisted
Keywords
Esophageal catheter calibration, Assisted mechanical ventilation
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EBC-assistedOther

    After definitive catheter positioning, esophageal balloon calibration will be performed in:

    1. volume-controlled mode with tidal volume set to obtain 6-8 lm/kg of ideal body weight (reference),
    2. 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);
    3. PSV + sigh ventilation (sigh setting: total inspiratory pressure equal to 35 cmH2O at a rate of 1/ minute; inspiratory time equal to 4 seconds).
Study groups in NCT03721237
Study groupRoleWhat they receive
EBC-assistedExperimentalA 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.
Receives: Other: EBC-assisted

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Over 120 minutes in PSV

  2. 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

    Measured: Over 30 minutes in PSV + Sigh

Secondary outcomes (3)

  1. Changes of respiratory mechanics indices in PSV

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

    Measured: over 30 minutes in PSV

  2. Changes of respiratory mechanics indices in PSV + sigh

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

    Measured: over 30 minutes in PSV + Sigh

  3. Gas exchange

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

    Measured: over 30 minutes during each trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2018
  2. Study start15 Nov 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03721237
Sponsor's protocol ID
CE 111/18
Acronym
EBC-PSV+Sigh
Status last verified
Dec 2018
First submitted
19 Oct 2018
Last updated
4 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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. doi: 10.1164/rccm.200203-198OC. Epub 2002 Dec 18.

    PubMed 12493644

  • 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.

    PubMed 11964584

  • 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.

    PubMed 9351606

  • 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.

    PubMed 15469597

  • 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.

    PubMed 16540960

  • 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.

    PubMed 7149443

  • 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.

    PubMed 27160458

  • 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.

    PubMed 27063290

  • 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.

    PubMed 28828367

Questions about this trial

What is this clinical trial studying?

A study testing EBC-assisted in people with Respiratory Failure and Mechanical Ventilation Pressure High, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of ventilatory mode on calibrated esophageal ballon best volume (time frame: Over 120 minutes in PSV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03721237, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.

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