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NCT04329910
Obesity Alters Lung Mechanics in Robotic Surgery
trial testing no intervention in Obesity in 99 participants. Completed in 12 July 2019.
12 July 2019
Quick facts
| Lead sponsor | University of Vermont Medical Center |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 99 |
| Start date | 22 November 2017 |
| Primary completion | 12 July 2019 |
| Estimated completion | 12 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- no intervention
Conditions studied
- Obesity — all drugs for Obesity →
- Surgery — all drugs for Surgery →
- Anesthesia — all drugs for Anesthesia →
Sponsor
University of Vermont Medical Center
Who can join
18 and older, any sex, with Obesity or Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04329910
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04329910 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Vermont Medical Center
- Last refreshed: 1 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04329910.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing