Obesity Alters Lung Mechanics in Robotic Surgery

NCT04329910 | Completed

• 1 other identifier: M18-0048
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Transpulmonary pressure

  during the surgical procedure

Study Arms (5)

Lean

BMI \< 25

Other: no intervention

overweight

BMI 25 - 29.9

Other: no intervention

class i obesity

BMI 30 -34.9

Other: no intervention

class ii obesity

BMI 35 - 39.9

Other: no intervention

class iii obesity

BMI \>= 40

Other: no intervention

Interventions

no intervention OTHER

no intervention - observational only

Lean; class i obesity; class ii obesity; class iii obesity; overweight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing robotic assisted laparoscopic abdominal surgery at the University of Vermont Medical Center

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

University of Vemont Medical Center

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: November 22, 2017
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)