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Clinical Trials/NCT04329910
NCT04329910
Completed
Not Applicable

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

University of Vermont Medical Center1 site in 1 country99 target enrollmentNovember 22, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Vermont Medical Center
Enrollment
99
Locations
1
Primary Endpoint
Transpulmonary pressure
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 22, 2017
End Date
July 12, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

William G Tharp

Assistant Professor

University of Vermont Medical Center

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Transpulmonary pressure

Time Frame: during the surgical procedure

Study Sites (1)

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