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Clinical Trials/NCT03746236
NCT03746236
Unknown
Not Applicable

Transpulmonary Pressure Under Conditions of Increased Intra-abdominal Pressure From Pneumoperitoneum and Steep Trendelenburg

Regina Elena Cancer Institute1 site in 1 country20 target enrollmentNovember 14, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ventilator-Induced Lung Injury
Sponsor
Regina Elena Cancer Institute
Enrollment
20
Locations
1
Primary Endpoint
Incidence of postoperative acute complications
Last Updated
6 years ago

Overview

Brief Summary

Study aims to prospectively evaluate if the pressures normally applied during mechanical ventilation in laparoscopic surgery induce stress on the pulmonary wall. To do this is used measure the variation of esophageal pressure, as indirect index of the pleural pressure and therefore of the transpulmonary pressure, in response to changes in airway pressures in a group of patients undergoing robotic assisted radical prostatectomy or videolaparoscopy.

Registry
clinicaltrials.gov
Start Date
November 14, 2018
End Date
December 30, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ester Forastiere

Head of Department of Anaestesiology and Critical Care

Regina Elena Cancer Institute

Eligibility Criteria

Inclusion Criteria

  • ASA (american society of anesthesiologists) score ≤ III
  • Patients underwent laparoscopic prostatectomy

Exclusion Criteria

  • BMI (body mass index) ≥ 30
  • Impossibility to insert nasogastric tube
  • Anatomic rib cage alterations

Outcomes

Primary Outcomes

Incidence of postoperative acute complications

Time Frame: 24 hours

Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization

Dosage of inflammatory mediators

Time Frame: 24 hours

Dosage of metalloproteinase and interleukin 8 in bronchoaspiration

Study Sites (1)

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