Obesity Alters Lung Mechanics in Robotic Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329910
• Other study ID #: M18-0048
• Status: Completed
• Start date: November 22, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: March 2020
• Source: University of Vermont Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 12, 2019
• Est. primary completion date: July 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Obesity
• Surgery

Intervention

Other:
• no intervention
no intervention - observational only

Locations

Country	Name	City	State
United States	University of Vemont Medical Center	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transpulmonary pressure		during the surgical procedure