Ventilation and Esophageal Pressure Changes

Mechanical Ventilation Clinical Trial

Official title:

A Study of Intraoperative Transpulmonary and Intrathoracic Pressure Changes Associated With Ventilator Management of Tidal Volume and Positive End-expiratory Pressure (PEEP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859672
• Other study ID #: 1903822
• Status: Recruiting
• Start date: June 16, 2022
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: University of California, Davis
• Contact: Neal Fleming, MD, PhD
• Phone: 916 734-5046
• Email: nwfleming[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrathoracic Pressure	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	Intra-operative
Secondary	Stroke Volume Variation	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.	Intra-operative