Esophageal Balloon Measurements to Better Characterize Thoraco-abdominal Interrelationship Mechanics.

Mechanical Ventilation Guided By Transpulmonary and Airway Driving Pressures in the Setting of Intra-abdominal Hypertension

Esophageal pressure measurements in surgical patients requiring mechanical ventilation during abdominal laparoscopic or robotic surgeries requiring intra-abdominal insufflation.

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Other: Esophageal pressure measurement guided ventilation

Detailed Description

Decades of research and clinical observation in mechanical ventilation have demonstrated unequivocally that tidal volume (VT), plateau pressure (PPLAT) and PEEP (positive end-expiratory pressure) influence ventilator induced lung injury. Clinicians, however, have struggled in the attempt to find a single indicator of safety and risk. Recent analyses of the large multi-center randomized trials database suggest that Airway Driving Pressure (ADP) and Trans pulmonary Driving Pressure (DTP) are the variables of greatest importance and therefore the best single parameters on which to focus. In attempting to define their optimal values and their correlation between each other in the setting of intra-abdominal hypertension, we would like to compare standard of care mechanical ventilation (control) with mechanical ventilation guided by DTP and ADP (intervention) in patients undergoing abdominal laparoscopic surgery.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients requiring mechanical ventilation for abdominal laparoscopic and robotic surgeries.
• Patients who are passively ventilated (no respiratory efforts) as a result of the sedation plan determined entirely by the primary anesthesia team --research team will not influence or participate on the sedation protocol plan or implementation.
• Patients who are clinically stable and able to tolerate the changes in position that are routinely conducted as part of the standard of care in the operative room.
• Patient/responsible family member signing the informed consent must speak English.

Exclusion criteria:

• Patients with open abdomen prior to surgical procedures.
• Females of childbearing age (18-50) with the potential to become pregnant and no clinically documented negative pregnancy test.
• Patients with clinically evident spontaneous breathing efforts (ventilator wave forms) during surgical procedure.
• Patients with clinical suspicion of elevated intra-cranial pressure (requiring head elevation).
• Contraindication to body position change, as dictated by surgery-specific protocol.
• Unstable cardio-respiratory insufficiency.
• Age less than 18 years.
• Cuff leak in endotracheal / tracheostomy tube.
• Patient/responsible family member unable to understand the informed consent in English.

• Patient with contraindication for nasogastric tube placement:

  • Severe midface trauma
  • Recent nasopharyngeal surgery
  • Coagulation abnormality
  • Esophageal varices, stricture, ulcerations, or tumors
  • Recent banding of esophageal varices
  • Alkaline ingestion
  • Diverticulitis,
  • Sinusitis, epistaxis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care mechanical ventilation; Anesthesia and surgical procedures will be performed following standard of care for mechanical ventilation during surgery.
Active Comparator: Transpulmonary pressure guided mechanical ventilation; Same treatment as the control group with the addition of esophageal pressure measurements used to guide mechanical ventilation during surgery.	Other: Esophageal pressure measurement guided ventilation; Use of esophageal pressure measurements to guide mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway driving pressure guided mechanical ventilation determined by esophageal balloon catheter measurements.	Optimizing the relationship between intra-abdominal pressure and both airway driving pressure and trans pulmonary driving pressure utilizing esophageal balloon measurements to guide mechanical ventilation.	Through study completion, an average of one year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Richard A Oeckler, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 26, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 16-007482

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No