ObesityNCT04329910
Obesity Alters Lung Mechanics in Robotic Surgery
An observational study of Obesity and Surgery, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
Intraoperative lung protective ventilation strategies using standardized tidal volumes based on predicted body weight have proven beneficial, but attempts to standardize positive end expiratory pressure (PEEP) settings have not robustly accounted for body habitus or dynamic surgical conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Surgery, Anesthesia
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2017to 12 Jul 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing robotic assisted laparoscopic abdominal surgery at the University of Vermont Medical Center
Who may be able to join
- Inclusion criteria were presentation for robotic assisted laparoscopic abdominal surgery in the supine position, age ≥ 18 years, and ability to provide informed consent
Who cannot join
- Exclusion criteria included intrinsic lung disease, ≥ 20 pack year smoking history, reactive airways disease, home oxygen requirement, inability to provide informed consent, emergent surgery, or esophageal pathology (i.e., strictures, varices, history of esophageal dilatation or surgery).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vemont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Dynamic Surgical Conditions and Body Habitus Independently Impair Pulmonary Mechanics During Robotic Assisted Laparoscopic Surgery: A Cross-Sectional Study
Intraoperative lung protective ventilation strategies using standardized tidal volumes based on predicted body weight have proven beneficial, but attempts to standardize positive end expiratory pressure (PEEP) settings have not robustly accounted for body habitus or dynamic surgical conditions. Laparoscopic abdominal surgery in Trendelenburg (head-down) is an increasingly common surgical modality that presents a unique physiological challenge to the pulmonary system. In order to delineate the impact of body habitus, pneumoperitoneum, and surgical positioning on intraoperative pulmonary mechanics we conducted an observational study of patients undergoing robotic assisted laparoscopic abdominal surgery in Trendelenburg position. Using esophageal manometry, we partitioned the mechanical properties of the respiratory system into its lung and chest wall components and evaluated the effects of pneumoperitoneum, surgical position, and body mass index (BMI) on transpulmonary pressures, airway and transpulmonary driving pressures, and lung elastance. We hypothesized that increasing BMI would be associated with evidence of increasing atelectasis, increased driving pressures, and elevated lung elastance and that these changes would be exacerbated by pneumoperitoneum and Trendelenburg positioning.
- Conditions
- Obesity, Surgery, Anesthesia
- Being tested
- no intervention
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention - observational only
| Study group | Role | What they receive |
|---|---|---|
| Lean | BMI < 25 Receives: Other: no intervention | |
| overweight | BMI 25 - 29.9 Receives: Other: no intervention | |
| class i obesity | BMI 30 -34.9 Receives: Other: no intervention | |
| class ii obesity | BMI 35 - 39.9 Receives: Other: no intervention | |
| class iii obesity | BMI >= 40 Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transpulmonary pressure
Measured: during the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start22 Nov 2017
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William G Tharp, University of Vermont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329910
- Sponsor's protocol ID
- M18-0048
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Surgical Conditions and Body Habitus Independently Impair Pulmonary Mechanics During Robotic Assisted Laparoscopic Surgery: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT04329910
- Acronym / sponsor ID
- M18-0048
- Conditions
- Obesity, Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 1 Apr 2020 (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.
Intraoperative lung protective ventilation strategies using standardized tidal volumes based on predicted body weight have proven beneficial, but attempts to standardize positive end expiratory pressure (PEEP) settings have not robustly accounted for body habitus or dynamic surgical conditions. Laparoscopic abdominal surgery in Trendelenburg (head-down) is an increasingly common surgical modality that presents a unique physiological challenge to the pulmonary system. In order to delineate the impact of body habitus, pneumoperitoneum, and surgical positioning on intraoperative pulmonary mechanics we conducted an observational study of patients undergoing robotic assisted laparoscopic abdominal surgery in Trendelenburg position. Using esophageal manometry, we partitioned the mechanical properties of the respiratory system into its lung and chest wall components and evaluated the effects of pneumoperitoneum, surgical position, and body mass index (BMI) on transpulmonary pressures, airway and transpulmonary driving pressures, and lung elastance. We hypothesized that increasing BMI would be associated with evidence of increasing atelectasis, increased driving pressures, and elevated lung elastance and that these changes would be exacerbated by pneumoperitoneum and Trendelenburg positioning.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lean | – | Other: no interventionBMI < 25 |
| overweight | – | Other: no interventionBMI 25 - 29.9 |
| class i obesity | – | Other: no interventionBMI 30 -34.9 |
| class ii obesity | – | Other: no interventionBMI 35 - 39.9 |
| class iii obesity | – | Other: no interventionBMI >= 40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing robotic assisted laparoscopic abdominal surgery at the University of Vermont Medical Center
Key inclusion criteria (1 listed)
- Inclusion criteria were presentation for robotic assisted laparoscopic abdominal surgery in the supine position, age ≥ 18 years, and ability to provide informed consent
Key exclusion criteria (1 listed)
- Exclusion criteria included intrinsic lung disease, ≥ 20 pack year smoking history, reactive airways disease, home oxygen requirement, inability to provide informed consent, emergent surgery, or esophageal pathology (i.e., strictures, varices, history of esophageal dilatation or surgery).
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 |
|---|---|---|
| no interventionno intervention - observational only | Other | Lean, class i obesity, class ii obesity, class iii obesity, overweight |
Primary outcome
Transpulmonary pressure
Time frame: during the surgical procedure
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 1 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Surgery, run by University of Vermont Medical Center 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 1 inclusion and 1 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 1 Apr 2020. 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?
Transpulmonary pressure (time frame: during the surgical procedure). 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 1 Apr 2020.