In vivo calibration of esophageal pressure in the mechanically ventilated patient makes measurements reliable.
Francesco Mojoli, Giorgio Antonio Iotti, Francesca Torriglia...
https://pubmed.ncbi.nlm.nih.gov/27063290Actively Recruiting
Age: 18Years +
All Genders
ID06584604
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation (PESCA)
Led by Leiden University Medical Center · Updated on 2025-04-22
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
H
Hamilton Medical AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the calibration of the esophageal balloon catheter (Pes catheter) used during mechanical ventilation to measure esophageal pressure (Pes) and calculate transpulmonary pressure (PL). This measurement helps set ventilator pressures and assess patient breathing effort, which is important in managing patients with conditions like early, severe ARDS. Calibration has been validated only in passive ventilation but not in spontaneous breathing with ventilator support, where chest forces differ and may affect calibration accuracy and patient care.
CONDITIONS
Brief Title
Calibration of Esophageal Balloon Catheter in Spontaneous and Mandatory Mechanical Ventilation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Mechanically ventilated in spontaneous mode
- Sedated with Richmond Agitation Sedation Scale (RASS) between -3 and -5
- Pes catheter placed according to the LUMC protocol
You will not qualify if you...
- Medical condition that prevents placement of a Pes catheter
- History of allergic reaction to rocuronium
- Pregnant
- Richmond Agitation Sedation Scale (RASS) greater than -3
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 45 minutes
Participants undergo calibration of the esophageal balloon catheter to measure esophageal pressures at different filling volumes while on mechanical ventilation.
1 visit (in-person)
Long-term Monitoring
Duration - No specific duration defined
Participants are observed to compare differences in optimal filling volume between spontaneous breathing and passive ventilation modes.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
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Research Team
W
Willem Snoep, BSc
A
Abraham Schoe, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Mechanical ventilation guided by esophageal pressure in acute lung injury.
Daniel Talmor, Todd Sarge, Atul Malhotra...
https://pubmed.ncbi.nlm.nih.gov/19001507Effect 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.
Jeremy R Beitler, Todd Sarge, Valerie M Banner-Goodspeed...
https://pubmed.ncbi.nlm.nih.gov/30776290Fifty Years of Research in ARDS. Spontaneous Breathing during Mechanical Ventilation. Risks, Mechanisms, and Management.
Takeshi Yoshida, Yuji Fujino, Marcelo B P Amato...
https://pubmed.ncbi.nlm.nih.gov/27786562Patient self-inflicted lung injury and positive end-expiratory pressure for safe spontaneous breathing.
Takeshi Yoshida, Domenico L Grieco, Laurent Brochard...
https://pubmed.ncbi.nlm.nih.gov/31815775