Transpulmonary Pressure Under Stressing Conditions

• Conditions: Ventilator-Induced Lung Injury

• Registration Number: NCT03746236
• Lead Sponsor: Regina Elena Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study Start: 2018-11-14
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-11
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative acute complications	24 hours	Evaluation of pulmonary alterations using pre and postoperative ultrasonographic visualization
Dosage of inflammatory mediators	24 hours	Dosage of metalloproteinase and interleukin 8 in bronchoaspiration

Trial Locations

Locations (1)

Regina Elena National Cancer Institute; 🇮🇹 Rome, Italy