Clincosm LogoSign in Get a demo

Transpulmonary Pressure Under Stressing Conditions

Sponsor
Regina Elena Cancer Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT03746236
Collaborator
(none)
20
Enrollment
2
Locations
13.5
Anticipated Duration (Months)
10
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Transpulmonary Pressure Under Conditions of Increased Intra-abdominal Pressure From Pneumoperitoneum and Steep Trendelenburg
    Actual Study Start Date :
    Nov 14, 2018
    Anticipated Primary Completion Date :
    Dec 30, 2019
    Anticipated Study Completion Date :
    Dec 30, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative acute complications [24 hours]

      Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization

    2. Dosage of inflammatory mediators [24 hours]

      Dosage of metalloproteinase and interleukin 8 in bronchoaspiration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regina Elena National Cancer Institute Rome Rm Italy 00153
    2 Regina Elena National Cancer Institute Rome Italy 00154

    Sponsors and Collaborators

    • Regina Elena Cancer Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ester Forastiere, Head of Department of Anaestesiology and Critical Care, Regina Elena Cancer Institute
    ClinicalTrials.gov Identifier:
    NCT03746236
    Other Study ID Numbers:
    • RS1138/18
    First Posted:
    Nov 19, 2018
    Last Update Posted:
    Sep 11, 2019
    Last Verified:
    Nov 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Injury
    Ventilator-Induced Lung Injury

    Study Results

    No Results Posted as of Sep 11, 2019