SurgeryNCT03624491
Esophageal Balloon Measurements to Better Characterize Thoraco-abdominal Interrelationship Mechanics.
A study testing Esophageal pressure measurement guided ventilation in people with Surgery, run by Mayo Clinic at 1 site in United States.
Trial summary
Esophageal pressure measurements in surgical patients requiring mechanical ventilation during abdominal laparoscopic or robotic surgeries requiring intra-abdominal insufflation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Esophageal pressure measurement guided ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2018to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Mechanical Ventilation Guided By Transpulmonary and Airway Driving Pressures in the Setting of Intra-abdominal Hypertension
Esophageal pressure measurements in surgical patients requiring mechanical ventilation during abdominal laparoscopic or robotic surgeries requiring intra-abdominal insufflation.
Read the 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
- Being tested
- Esophageal pressure measurement guided ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal pressure measurement guided ventilationOther
Use of esophageal pressure measurements to guide mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Esophageal pressure measurement guided ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start13 Mar 2018
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to two different groups.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard A. Oeckler, M.D., Ph.D., Mayo Clinic
- Investigators
- Richard A Oeckler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624491
- Sponsor's protocol ID
- 16-007482
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Ventilation Guided By Transpulmonary and Airway Driving Pressures in the Setting of Intra-abdominal Hypertension
- ClinicalTrials.gov ID
- NCT03624491
- Acronym / sponsor ID
- 16-007482
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to two different groups.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Esophageal pressure measurement guided ventilationSame treatment as the control group with the addition of esophageal pressure measurements used to guide mechanical ventilation during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal pressure measurement guided ventilationUse of esophageal pressure measurements to guide mechanical ventilation | Other | Transpulmonary pressure guided mechanical ventilation |
Primary outcome
Airway driving pressure guided mechanical ventilation determined by esophageal balloon catheter measurements.
Time frame: Through study completion, an average of one year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Oeckler, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophageal pressure measurement guided ventilation in people with Surgery, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway driving pressure guided mechanical ventilation determined by esophageal balloon catheter measurements. (time frame: Through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.