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NCT03746236 Clinical Trial

Transpulmonary Pressure Under Stressing Conditions

Ventilator-Induced Lung Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03746236
Other study ID # RS1138/18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2018
Est. completion date December 30, 2019

Study information
Verified date November 2018
Source Regina Elena Cancer Institute
Contact Ester Forastiere, chief
Email ester.forastiere@ifo.gov.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Regina Elena National Cancer Institute Rome Rm
Italy Regina Elena National Cancer Institute Rome

Sponsors (1)
Lead Sponsor Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative acute complications Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization 24 hours
Primary Dosage of inflammatory mediators Dosage of metalloproteinase and interleukin 8 in bronchoaspiration 24 hours
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