Ventilation and Esophageal Pressure Changes

Recruiting

• Conditions: Mechanical Ventilation

• Registration Number: NCT05859672
• Lead Sponsor: University of California, Davis

Brief Summary

A study to observe the effect of variations in ventilator settings including tidal volume and PEEP on transpulmonary pressure monitored with an esophageal balloon catheter and to correlate intraoperative transpulmonary pressure variations and intraoperative stroke volume variation changes.

Detailed Description

This study seeks to observe the effects of variations in ventilator settings on transpulmonary and intrathoracic pressures. More specifically, to observe the impact of variations in tidal volume from 6 mL/kg to 8 mL/kg and PEEP from 0 cm of water (H2O) to 5 cm H2O on transpulmonary and intrathoracic pressures monitored with an esophageal balloon catheter. The impact of this recommended decrease in tidal volume on the clinical utility of stroke volume variation (SVV) as a guide for fluid administration has not been previously examined.

Study Timeline

• Study Start: 2022-06-16
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients scheduled for elective surgery requiring general anesthesia and endotracheal intubation.
• Age ≥ 18

Exclusion Criteria

• Patients undergoing planned esophageal surgery
• Patients with significant nasal or esophageal pathology
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intrathoracic Pressure	Intra-operative	Measure the intrathoracic pressure changes monitored with an esophageal pressure balloon catheter associated with intraoperative changes in mechanical ventilation parameters such as tidal volume and PEEP

Secondary Outcome Measures

Name	Time	Method
Stroke Volume Variation	Intra-operative	Characterizing the changes in SVV associated with intraoperative changes in mechanical ventilation parameters such as tidal volume and PEEP and the correlations with changes in intrathoracic pressure.

Trial Locations

Locations (1)

UC Davis Medical Center; 🇺🇸 Sacramento, California, United States