Clinical trial NCT03624491: Esophageal Balloon Measurements to Better Characterize Thoraco-abdominal Interrelationship Mechanics.
Official title: Mechanical Ventilation Guided By Transpulmonary and Airway Driving Pressures in the Setting of Intra-abdominal Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to two different groups.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Airway driving pressure guided mechanical ventilation determined by esophageal balloon catheter measurements.
timeFrame: Through study completion, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Richard A Oeckler, MD
role: PRINCIPAL_INVESTIGATOR
References: