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

NCT03624491 | Completed

• 1 other identifier: 16-007482
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of care mechanical ventilation

NO INTERVENTION

Anesthesia and surgical procedures will be performed following standard of care for mechanical ventilation during surgery.

Transpulmonary pressure guided mechanical ventilation

ACTIVE COMPARATOR

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

Interventions

Esophageal pressure measurement guided ventilation OTHER

Use of esophageal pressure measurements to guide mechanical ventilation

Transpulmonary pressure guided mechanical ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Richard A Oeckler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a prospective, open label, randomized study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine and Physiology-Critical Care

Model Details: Randomization to two different groups.

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: August 10, 2018
• Study Start: March 13, 2018
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)