Obesity Alters Lung Mechanics in Robotic Surgery

NCT ID: NCT04329910

Last Updated: 2020-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-22

Study Completion Date

2019-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Surgery Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Lean

BMI \< 25

no intervention

Intervention Type OTHER

no intervention - observational only

overweight

BMI 25 - 29.9

no intervention

Intervention Type OTHER

no intervention - observational only

class i obesity

BMI 30 -34.9

no intervention

Intervention Type OTHER

no intervention - observational only

class ii obesity

BMI 35 - 39.9

no intervention

Intervention Type OTHER

no intervention - observational only

class iii obesity

BMI \>= 40

no intervention

Intervention Type OTHER

no intervention - observational only

Interventions

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no intervention

no intervention - observational only

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Vermont Medical Center

OTHER

Sponsor Role lead

Responsible Party

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William G Tharp

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Vemont Medical Center

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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M18-0048

Identifier Type: -

Identifier Source: org_study_id

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