Mechanical Ventilation Guided By Transpulmonary and Airway Driving Pressures
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007482
NCT ID: NCT03624491
Sponsor Protocol Number: 16-007482
About this study
The purpose of this study is to test the correspondence between Airway Driving Pressure (DPAW; defined as plateau pressure minus positive end-expiratory pressure) and transpulmonary driving pressure (DPTP)—the quotient of tidal volume and lung compliance (CL), in response to intra-abdominal hypertension and changes in positive end-expiratory pressure during laparoscopic and robotic surgical interventions requiring intra-abdominal insufflation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
- Body mass index (BMI) greater than 35.
- 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 nasal surgery
- Coagulation abnormality
- Esophageal varices or stricture
- Recent banding of esophageal varices
- Alkaline ingestion
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available