Intensive Care UnitPESCANCT06584604
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation
An observational study of Intensive Care Unit and Mechanical Ventilation, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit, Mechanical Ventilation, Critical Illness
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Dec 2024to Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: ICU patients who are on mechanical ventilation with a esophageal balloon catheter in situ according to the current LUMC protocol. Expected mechanical ventilation time \> 24 hrs. RASS between -3 and -5;
Who may be able to join
- 18 years or older.
- Mechanically ventilated in spontaneous mode.
- Sedated (Richmond Agitation Sedation Scale (RASS) between -3 and -5).
- Pes catheter in situ according to the protocol used in the LUMC (Insertion of a Pes catheter is mandatory if it is suspected that te patient will be ventilated for more than 24 hrs.).
Who cannot join
- Medical condition that excludes the placement of a Pes catheter.
- Allergic reaction against rocuronium in the past.
- Pregnant.
- RASS \> -3
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abraham Schoe, MD, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
Willem Snoep, BSc, +31715262164, j.w.m.snoep@lumc.nl
About this study
Official title: Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation (PESCA)
Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.
Read the detailed description
In mechanical ventilation the esophageal pressure (Pes) is used to calculate the transpulmonary pressure (PL). The transpulmonary pressure is used to set the positive end expiratory pressure (PEEP) and the inspiratory pressure. In spontaneous mechanical ventilation the transpulmonary pressure swing (which is the difference between the maximum and minimum transpulmonary pressure) is used as a measure of patient effort. Too much patient effort is perhaps detrimental in patients with early, severe ARDS, leading to additional lung damage and possibly a prolonged ICU stay.
The Pes is measured using a separate or integrated (feeding tube and Pes catheter) esophageal balloon catheter. The catheter is placed in the right position and has to be inflated to produce a readable pressure signal. The Pes balloon needs calibration before measurement to be sure that the readings are trustworthy. When calibrating one should take the compliance of the esophagus into account, together with the calibration curve, and with that, the filling volume of the patient changes from patient to patient. A calibration study of the Pes catheter has only been performed in passive mechanically ventilated patients, i.e. in patients without any breathing efforts.
In spontaneous breathing patients who still needs support from the ventilator, the forces within the thorax differ considerably in comparison with passive patients. When initiating a breath the diaphragm of the patient will move downwards and the Pes will become negative. In passive patient the ventilator initiates the breath and the diaphragm will be pushed downwards but the Pes will become more positive. It is probable that the calibration methods used in passive patients is not feasible in patients who exhibit a breathing effort. It is therefore necessary to study the calibration of the esophageal balloon catheter in patients that breath spontaneously with the support of a mechanical ventilator.
The hypothesis is that the calibration method, and therefore the filling pressure of the balloon is different from the values when the patient would be ventilated in a passive mode. Wrong calibration leads to wrong values, which could possibly lead to wrong interpretation of the obtained values with possible harm for the patient.
- Being tested
- There is no intervention
- Keywords
- Esophageal Pressure, Esophageal Balloon Catheter, Transpulmonary Pressure, Mandatory Ventilation, Support Ventilation
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal pressures (in cmH2O) measured by the balloon catheter at different filling volumes (in ml)
To obtain a calibration method for the oesophageal balloon catheter in patients ventilated with a support mode and breathing spontaneously. Two, often used balloon catheters will be tested.
Measured: 45 minutes
Secondary outcomes (1)
The difference of optimal filling volume in spontaneously breathing and in passive ventilation (in cmH2O)
After measurements of the esophageal balloon were done during spontaneously breathing patients, measurements were done during mandatory ventilation while patient is passive. The measurements are the values and the optimal filling volume of the esophageal balloon in spontaneously breathing and in a passive mode.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start29 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Medical AG
- Responsible party
- Principal investigator, Abraham Schoe, MD, PhD., Leiden University Medical Center
- Investigators
- Abraham Schoe, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584604
- Sponsor's protocol ID
- NL83335.058.24
- Acronym
- PESCA
- Status last verified
- Apr 2025
- First submitted
- 2 Sep 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon request with researchers.
Publications
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 27063290Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PubMed 19001507Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
PubMed 30776290Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
PubMed 27786562Yoshida T, Grieco DL, Brochard L, Fujino Y. Patient self-inflicted lung injury and positive end-expiratory pressure for safe spontaneous breathing. Curr Opin Crit Care. 2020 Feb;26(1):59-65. doi: 10.1097/MCC.0000000000000691.
PubMed 31815775
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation (PESCA)
- ClinicalTrials.gov ID
- NCT06584604
- Acronym / sponsor ID
- PESCA / NL83335.058.24
- Keywords
- Esophageal Pressure, Esophageal Balloon Catheter, Transpulmonary Pressure, Mandatory Ventilation, Support Ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Hamilton Medical AG
- Study start
- 29 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Calibration of the esophageal balloon catheter (Pes catheter) is important for the right measurement of the esophageal pressure (Pes) and subsequent interpretation of the derived transpulmonary pressures during mechanical ventilation. Both relative changes and absolute values of Pes can be affected by inappropriate filling of the esophageal balloon and by the elastance of the esophagus wall. Therefore one should calibrate the balloon to determine the best filling pressure. Calibration of the Pes catheter has only been validated in mandatory ventilation but not in support modes in which the patient triggers the ventilator and is supported by the mechanical ventilator. Because the forces in the thoracic cage behave differently in comparison with a controlled mode, it is to be expected that the calibration process in a support mode yields different filling volumes in comparison with the calibration process in a controlled mode. This would lead to a more reliable filling volume in support mechanical ventilation and a more reliable derivation of transpulmonary pressure and therefore to a better treatment of patients.
Detailed description
In mechanical ventilation the esophageal pressure (Pes) is used to calculate the transpulmonary pressure (PL). The transpulmonary pressure is used to set the positive end expiratory pressure (PEEP) and the inspiratory pressure. In spontaneous mechanical ventilation the transpulmonary pressure swing (which is the difference between the maximum and minimum transpulmonary pressure) is used as a measure of patient effort. Too much patient effort is perhaps detrimental in patients with early, severe ARDS, leading to additional lung damage and possibly a prolonged ICU stay.
The Pes is measured using a separate or integrated (feeding tube and Pes catheter) esophageal balloon catheter. The catheter is placed in the right position and has to be inflated to produce a readable pressure signal. The Pes balloon needs calibration before measurement to be sure that the readings are trustworthy. When calibrating one should take the compliance of the esophagus into account, together with the calibration curve, and with that, the filling volume of the patient changes from patient to patient. A calibration study of the Pes catheter has only been performed in passive mechanically ventilated patients, i.e. in patients without any breathing efforts.
In spontaneous breathing patients who still needs support from the ventilator, the forces within the thorax differ considerably in comparison with passive patients. When initiating a breath the diaphragm of the patient will move downwards and the Pes will become negative. In passive patient the ventilator initiates the breath and the diaphragm will be pushed downwards but the Pes will become more positive. It is probable that the calibration methods used in passive patients is not feasible in patients who exhibit a breathing effort. It is therefore necessary to study the calibration of the esophageal balloon catheter in patients that breath spontaneously with the support of a mechanical ventilator.
The hypothesis is that the calibration method, and therefore the filling pressure of the balloon is different from the values when the patient would be ventilated in a passive mode. Wrong calibration leads to wrong values, which could possibly lead to wrong interpretation of the obtained values with possible harm for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients who are on mechanical ventilation with a esophageal balloon catheter in situ according to the current LUMC protocol. Expected mechanical ventilation time \> 24 hrs. RASS between -3 and -5;
Key inclusion criteria (4 listed)
- 18 years or older.
- Mechanically ventilated in spontaneous mode.
- Sedated (Richmond Agitation Sedation Scale (RASS) between -3 and -5).
- Pes catheter in situ according to the protocol used in the LUMC (Insertion of a Pes catheter is mandatory if it is suspected that te patient will be ventilated for more than 24 hrs.).
Key exclusion criteria (4 listed)
- Medical condition that excludes the placement of a Pes catheter.
- Allergic reaction against rocuronium in the past.
- Pregnant.
- RASS \> -3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionThere is no intervention | Other | – |
Primary outcome
Esophageal pressures (in cmH2O) measured by the balloon catheter at different filling volumes (in ml)
Time frame: 45 minutes
To obtain a calibration method for the oesophageal balloon catheter in patients ventilated with a support mode and breathing spontaneously. Two, often used balloon catheters will be tested.
1 secondary outcome
The difference of optimal filling volume in spontaneously breathing and in passive ventilation (in cmH2O)
Time frame: 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Results publication: PubMed 27063290Mojoli 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 publication: PubMed 19001507Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
- Results publication: PubMed 30776290Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Results publication: PubMed 27786562Yoshida T, Fujino Y, Amato MB, Kavanagh BP. Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management. Am J Respir Crit Care Med. 2017 Apr 15;195(8):985-992. doi: 10.1164/rccm.201604-0748CP.
- Results publication: PubMed 31815775Yoshida T, Grieco DL, Brochard L, Fujino Y. Patient self-inflicted lung injury and positive end-expiratory pressure for safe spontaneous breathing. Curr Opin Crit Care. 2020 Feb;26(1):59-65. doi: 10.1097/MCC.0000000000000691.
- Individual participant dataSharing planned: Undecided. Data will be shared upon request with researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abraham Schoe, MD, PhD contact
Abraham Schoe, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit and Mechanical Ventilation, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Apr 2025. 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Willem Snoep, BSc (+31 (0)71-5262164, j.w.m.snoep@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressures (in cmH2O) measured by the balloon catheter at different filling volumes (in ml) (time frame: 45 minutes). 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 NCT06584604, which also lists 5 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 22 Apr 2025.