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

NCT ID: NCT03624491

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-13
• Study Completion Date: 2022-02-17

Brief Summary

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

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of care mechanical ventilation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Esophageal pressure measurement guided ventilation

Intervention Type: OTHER

Use of esophageal pressure measurements to guide mechanical ventilation

Interventions

Esophageal pressure measurement guided ventilation

Use of esophageal pressure measurements to guide mechanical ventilation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Richard A. Oeckler, M.D., Ph.D.

Assistant Professor of Medicine and Physiology-Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard A Oeckler, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayoclinic.org/

Mayo Clinic Clinical Trials

Other Identifiers

16-007482

Identifier Type: -

Identifier Source: org_study_id