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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624491
• Other study ID #: 16-007482
• Status: Completed
• Phase: N/A
• Start date: March 13, 2018
• Est. completion date: February 17, 2022

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Esophageal pressure measurement guided ventilation
Use of esophageal pressure measurements to guide mechanical ventilation

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials