Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation

NCT06584604 | Recruiting DMC

• 1 other identifier: NL83335.058.24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intensive Care Unit; Mechanical Ventilation; Critical Illness

Keywords

Esophageal Pressure; Esophageal Balloon Catheter; Transpulmonary Pressure; Mandatory Ventilation; Support Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  45 minutes

Secondary Outcomes (1)

• The difference of optimal filling volume in spontaneously breathing and in passive ventilation (in cmH2O)

  45 minutes

Interventions

There is no intervention OTHER

There is no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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;

You may qualify if:

• 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.).

You may not qualify if:

• Medical condition that excludes the placement of a Pes catheter.
• Allergic reaction against rocuronium in the past.
• Pregnant.
• RASS \> -3

Sponsors & Collaborators

• Leiden University Medical Center: lead
• Hamilton Medical AG: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Related Publications (5)

• 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.

  PMID: 27063290 BACKGROUND

• Talmor 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.

  PMID: 19001507 BACKGROUND

• Beitler 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.

  PMID: 30776290 BACKGROUND

• Yoshida 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.

  PMID: 27786562 BACKGROUND

• Yoshida 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.

  PMID: 31815775 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Abraham Schoe, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Willem Snoep, BSc

CONTACT

+31 (0)71-5262164; j.w.m.snoep@lumc.nl

Abraham Schoe, MD, PhD

CONTACT

a.schoe@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 5, 2024
• Study Start: December 29, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

NL (1)