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NCT04329910 · ClinicalTrials.gov registry record

Obesity Alters Lung Mechanics in Robotic Surgery

A clinical trial, sponsored by University of Vermont Medical Center.

Completed
Registry status
99
Enrollment target

NCT04329910: Completed study, sponsored by University of Vermont Medical Center.

NCT04329910 is a clinical trial that has completed, run by University of Vermont Medical Center. The registered enrollment target is 99 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04329910 has completed, sponsored by University of Vermont Medical Center.

COMPLETED
Registry status
99 participants
Enrollment target

Study 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. 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.

Interventions

  • OTHER no intervention

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2017-11-22
Est. Completion 2019-07-12

What the finished NCT04329910 record still lists

NCT04329910 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 99 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which no intervention is the first listed.

NCT04329910 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04329910 about?

NCT04329910 is a clinical study titled "Obesity Alters Lung Mechanics in Robotic Surgery". 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. Lapa...

What is the current status of trial NCT04329910?

This trial is currently completed. The enrollment target is 99 participants. The study started on 2017-11-22. Estimated completion is 2019-07-12.

What interventions are being tested in trial NCT04329910?

The interventions under investigation include: no intervention (OTHER).

Who is sponsoring clinical trial NCT04329910?

This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04329910, the US trial registry maintained by the National Library of Medicine. NCT04329910 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.