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OpenTrials
Completed

NCT Number: NCT04329910

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. 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Vemont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria were presentation for robotic assisted laparoscopic abdominal surgery in the supine position, age ≥ 18 years, and ability to provide informed consent

Exclusion criteria

  • 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).

Treatment and study plan

No intervention

Other

no intervention - observational only

Primary outcomes

  1. Transpulmonary pressure

    Time frame: during the surgical procedure

Sponsors and collaborators

Lead sponsor

University of Vermont Medical Center

Other

Registry information

Official study title

Dynamic Surgical Conditions and Body Habitus Independently Impair Pulmonary Mechanics During Robotic Assisted Laparoscopic Surgery: A Cross-Sectional Study

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2020
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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